Class I recalls
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Class II recalls
Date Posted | Recalling Manufacturer | Trade Name/Product | Reason for Recall |
Aug-01-2011 | Philips Medical Systems (Cleveland) Inc | MX8000 Dual v. Exp CT X-Ray System – Vertical Brake Hubs component of the Philips MX8000 Series Dual v. Exp. Computed Tomography System; Serial Numbers: 8008-8413; 80001-800022; Model #728130; 510 (k) #K010817.Product Usag: The MX 8000 series Dual v. Exp are Computed Tomography X-Ray system units intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. These devices may include signal analysis and display equipment; patient; and equipment supports; components and accessories. | Philips Medical Systems decided to conduct a recall/field correction of the patient support vertical brake hub component in all of their CT MX8000 Dual v. Exp Computed Tomography X-Ray System scanners due to a component defect which could cause an unexpected downward motion of the table (couch) while the patient is on the table. This event could occur because the short key connecting the vertical |
Aug-01-2011 | Philips Medical Systems (Cleveland) Inc | GEMINI TF Big Bore – GEMINI TF Big Bore computer tomograph software version 3.6. Catalog #882476; Gantry S/N 9001-9023.The GEMINI TF Big Bore is a diagnostic imaging systems for fixed or mobile installations that combines Positron Emission Tomography (PET) and X-ray Computed Tomography (CT) systems. The CT subsystem produces cross-sectional images of the body by computer reconstruction of x-ray transmission data. The PET subsystem produces images of the distribution of PET radiopharmaceuticals in the patient body (specific radiopharmaceuticals are used for whole body; brain; heart and other organ imaging). Attenuation correction is accomplished by CTAC. The device also provides for list mode; dynamic; and gated acquisitions. Both subsystems (PET and CT) can also be operated independently as fully functional; diagnostic imaging systems including application of the CT scanner as a radiation therapy simulation scanner. | Two non-safety related defects have been found on the Philips GEMINI TF Big Bore running version 3.6; if these defects were to recur; it could impact the performance or reliability of the system. Philips is issuing a software update to all Philips GEMINI TF Big Bore customers to correct these defects. |
Aug-01-2011 | Biomet Microfixation; Inc. | Center Drive Stainless Steel 2.0MM System Screwdriver Blade – "***BIOMET MICROFIXATION***CENTER DRIVE STAINLESS STEEL***2.0MM SYSTEM SCREWDRIVER BLADE***Non-Sterile Product***BIOMET MICROFIXATION 1520 TRADEPORT DRIVE JACKSONVILLE; FL 32218 USA www.biometmicrofixation.com***"Blade used to implant screws. | Biomet Microfixation; Jacksonville; FL is recalling Center Drive Blade; 2.0; Model Number 01-9047; Lot # 064980. Product is non-conforming (blades do not retain screws). |
Aug-01-2011 | Axiobionics; LLC | AxioBionics Wearable Therapy BioSleeve – AxioBionics Wearable Therapy Upper Extremity BioSleeve (Right and Left) that includes 2-16 BioGel Velcro Electrodes in sizes: 2"x2"; 2"x2.5"; 2"x3"; 2"x3.5"; 2"x4"; 2"x5"; 2"x6"; 2"x8"; 1.5"x3"; 1.5"x5"; 1.5"x6"; and 1"x1.5".Cutaneous electrode garments for neuromuscular electrical stimulation. | Premature Device Failure : Failure of the electrode sites to conduct and provide muscle stimulation due to silver fabric component failure. |
Aug-01-2011 | Axiobionics; LLC | AxioBionics Wearable Therapy FreeStep Sleeve – AxioBionics Wearable TherapyFreeStep Sleeve (Right and Left) that includes 2-16 BioGel Velcro Electrodes in sizes: 2"x2"; 2"x2.5"; 2"x3"; 2"x3.5"; 2"x4"; 2"x5"; 2"x6"; 2"x8"; 1.5"x3"; 1.5"x5"; 1.5"x6"; and 1"x1.5".Cutaneous electrode garments for neuromuscular electrical stimulation. | Premature Device Failure : Failure of the electrode sites to conduct and provide muscle stimulation due to silver fabric component failure. |
Aug-01-2011 | Axiobionics; LLC | AxioBionics Wearable Therapy BioShorts – AxioBionics Wearable Therapy BioShorts that includes 2-16 BioGel Velcro Electrodes in sizes: 2"x2"; 2"x2.5"; 2"x3"; 2"x3.5"; 2"x4"; 2"x5"; 2"x6"; 2"x8"; 1.5"x3"; 1.5"x5"; 1.5"x6"; and 1"x1.5".Cutaneous electrode garments for neuromuscular electrical stimulation. | Premature Device Failure : Failure of the electrode sites to conduct and provide muscle stimulation due to silver fabric component failure. |
Aug-01-2011 | Axiobionics; LLC | AxioBionics Wearable Therapy BioVest/Unitard – AxioBionics Wearable Therapy BioVest/Unitard that includes 2-16 BioGel Velcro Electrodes in sizes: 2"x2"; 2"x2.5"; 2"x3"; 2"x3.5"; 2"x4"; 2"x5"; 2"x6"; 2"x8"; 1.5"x3"; 1.5"x5"; 1.5"x6"; and 1"x1.5".Cutaneous electrode garments for neuromuscular electrical stimulation. | Premature Device Failure : Failure of the electrode sites to conduct and provide muscle stimulation due to silver fabric component failure. |
Aug-01-2011 | The Anspach Effort; Inc. | Anspach Single Use; Sterile Bone Cutting Burrs – ***REF MCA5-1SB; QTY: 1***1 mm Fluted Ball; 5.6 cm. Use with Micro Curved Attachment (MCA).***Sterilized using Irradiation***RX Only***ANSPACH Manufacturer***Made in USA***The Anspach Effort; Inc. 4500 Riverside Drive Palm Beach Gardens; FL 33410; USA Tel: (800) 327 6887 / + 1 561 627 1080***Anspach Europe Ltd. Aston Court; Kingsmead Business Park Frederick Place High Wycombe; HP 11 1LA United Kingdom Tel: +441494 616126******REF MCA7-1SB; QTY: 1***1 mm Fluted Ball; 7.3 cm. Use with Micro Curved Attachment (MCA).***Sterilized using Irradiation***RX Only***ANSPACH Manufacturer***Made in USA***The Anspach Effort; Inc. 4500 Riverside Drive Palm Beach Gardens; FL 33410; USA Tel: (800) 327 6887 / + 1 561 627 1080***Anspach Europe Ltd. Aston Court; Kingsmead Business Park Frederick Place High Wycombe; HP 11 1LA United Kingdom Tel: +441494 616126***Cutting and Shaping bone including bones of the spine and cranium | On July 30th; 2010 the Anspach Effort; Inc. initiated a voluntary recall on their Anspach Single Use; Sterile Bone Cutting Burrs. A complaint was recieved stating that the product had failed during a procedure. |
Aug-01-2011 | The Anspach Effort; Inc. | Anspach Single Use; Sterile Bone Cutting Burrs – ***REF MCA5-2SB; QTY: 1***2 mm Fluted Ball; 5.6 cm. Use with Micro Curved Attachment (MCA).***Sterilized using Irradiation***RX Only***ANSPACH Manufacturer***Made in USA***The Anspach Effort; Inc. 4500 Riverside Drive Palm Beach Gardens; FL 33410; USA Tel: (800) 327 6887 / + 1 561 627 1080***Anspach Europe Ltd. Aston Court; Kingsmead Business Park Frederick Place High Wycombe; HP 11 1LA United Kingdom Tel: +441494 616126******REF MCA7-2SB; QTY: 1***2 mm Fluted Ball; 7.3 cm. Use with Micro Curved Attachment (MCA).***Sterilized using Irradiation***RX Only***ANSPACH Manufacturer***Made in USA***The Anspach Effort; Inc. 4500 Riverside Drive Palm Beach Gardens; FL 33410; USA Tel: (800) 327 6887 / + 1 561 627 1080***Anspach Europe Ltd. Aston Court; Kingsmead Business Park Frederick Place High Wycombe; HP 11 1LA United Kingdom Tel: +441494 616126***Cutting and Shaping bone including bones of the spine and cranium | On July 30th; 2010 the Anspach Effort; Inc. initiated a voluntary recall on their Anspach Single Use; Sterile Bone Cutting Burrs. A complaint was recieved stating that the product had failed during a procedure. |
Aug-01-2011 | The Anspach Effort; Inc. | Anspach Single Use; Sterile Bone Cutting Burrs – ***REF MCA5-1SD; QTY: 1***1 mm Diamond Ball; 5.6 cm. Use with Micro Curved Attachment (MCA).***Sterilized using Irradiation***RX Only***ANSPACH Manufacturer***Made in USA***The Anspach Effort; Inc. 4500 Riverside Drive Palm Beach Gardens; FL 33410; USA Tel: (800) 327 6887 / + 1 561 627 1080***Anspach Europe Ltd. Aston Court; Kingsmead Business Park Frederick Place High Wycombe; HP 11 1LA United Kingdom Tel: +441494 616126******REF MCA7-1SD; QTY: 1***1 mm Diamond Ball; 7.3 cm. Use with Micro Curved Attachment (MCA).***Sterilized using Irradiation***RX Only***ANSPACH Manufacturer***Made in USA***The Anspach Effort; Inc. 4500 Riverside Drive Palm Beach Gardens; FL 33410; USA Tel: (800) 327 6887 / + 1 561 627 1080***Anspach Europe Ltd. Aston Court; Kingsmead Business Park Frederick Place High Wycombe; HP 11 1LA United Kingdom Tel: +441494 616126***Cutting and Shaping bone including bones of the spine and cranium | On July 30th; 2010 the Anspach Effort; Inc. initiated a voluntary recall on their Anspach Single Use; Sterile Bone Cutting Burrs. A complaint was recieved stating that the product had failed during a procedure. |
Aug-01-2011 | The Anspach Effort; Inc. | Anspach Single Use; Sterile Bone Cutting Burrs – ***REF MCA5-2SD; QTY: 1***2 mm Diamond Ball; 5.6 cm. Use with Micro Curved Attachment (MCA).***Sterilized using Irradiation***RX Only***ANSPACH Manufacturer***Made in USA***The Anspach Effort; Inc. 4500 Riverside Drive Palm Beach Gardens; FL 33410; USA Tel: (800) 327 6887 / + 1 561 627 1080***Anspach Europe Ltd. Aston Court; Kingsmead Business Park Frederick Place High Wycombe; HP 11 1LA United Kingdom Tel: +441494 616126******REF MCA7-2SD; QTY: 1***2 mm Diamond Ball; 7.3 cm. Use with Micro Curved Attachment (MCA).***Sterilized using Irradiation***RX Only***ANSPACH Manufacturer***Made in USA***The Anspach Effort; Inc. 4500 Riverside Drive Palm Beach Gardens; FL 33410; USA Tel: (800) 327 6887 / + 1 561 627 1080***Anspach Europe Ltd. Aston Court; Kingsmead Business Park Frederick Place High Wycombe; HP 11 1LA United Kingdom Tel: +441494 616126***Cutting and Shaping bone including bones of the spine and cranium | On July 30th; 2010 the Anspach Effort; Inc. initiated a voluntary recall on their Anspach Single Use; Sterile Bone Cutting Burrs. A complaint was recieved stating that the product had failed during a procedure. |
Aug-01-2011 | The Anspach Effort; Inc. | Anspach Single Use; Sterile Bone Cutting Burrs – ***REF MCA5-05SD; QTY: 1***0.5 mm Diamond Ball; 5.6 cm. Use with Micro Curved Attachment (MCA).***Sterilized using Irradiation***RX Only***ANSPACH Manufacturer***Made in USA***The Anspach Effort; Inc. 4500 Riverside Drive Palm Beach Gardens; FL 33410; USA Tel: (800) 327 6887 / + 1 561 627 1080***Anspach Europe Ltd. Aston Court; Kingsmead Business Park Frederick Place High Wycombe; HP 11 1LA United Kingdom Tel: +441494 616126******REF MCA7-05SD; QTY: 1***0.5 mm Diamond Ball; 7.3 cm. Use with Micro Curved Attachment (MCA).***Sterilized using Irradiation***RX Only***ANSPACH Manufacturer***Made in USA***The Anspach Effort; Inc. 4500 Riverside Drive Palm Beach Gardens; FL 33410; USA Tel: (800) 327 6887 / + 1 561 627 1080***Anspach Europe Ltd. Aston Court; Kingsmead Business Park Frederick Place High Wycombe; HP 11 1LA United Kingdom Tel: +441494 616126***Cutting and Shaping bone including bones of the spine and cranium | On July 30th; 2010 the Anspach Effort; Inc. initiated a voluntary recall on their Anspach Single Use; Sterile Bone Cutting Burrs. A complaint was recieved stating that the product had failed during a procedure. |
Aug-01-2011 | The Anspach Effort; Inc. | Anspach Single Use; Sterile Bone Cutting Burrs – ***REF MCA5-06SD; QTY: 1***0.6 mm Diamond Ball; 5.6 cm. Use with Micro Curved Attachment (MCA).***Sterilized using Irradiation***RX Only***ANSPACH Manufacturer***Made in USA***The Anspach Effort; Inc. 4500 Riverside Drive Palm Beach Gardens; FL 33410; USA Tel: (800) 327 6887 / + 1 561 627 1080***Anspach Europe Ltd. Aston Court; Kingsmead Business Park Frederick Place High Wycombe; HP 11 1LA United Kingdom Tel: +441494 616126******REF MCA7-06SD; QTY: 1***0.6 mm Diamond Ball; 7.3 cm. Use with Micro Curved Attachment (MCA).***Sterilized using Irradiation***RX Only***ANSPACH Manufacturer***Made in USA***The Anspach Effort; Inc. 4500 Riverside Drive Palm Beach Gardens; FL 33410; USA Tel: (800) 327 6887 / + 1 561 627 1080***Anspach Europe Ltd. Aston Court; Kingsmead Business Park Frederick Place High Wycombe; HP 11 1LA United Kingdom Tel: +441494 616126***Cutting and Shaping bone including bones of the spine and cranium | On July 30th; 2010 the Anspach Effort; Inc. initiated a voluntary recall on their Anspach Single Use; Sterile Bone Cutting Burrs. A complaint was recieved stating that the product had failed during a procedure. |
Aug-01-2011 | The Anspach Effort; Inc. | Anspach Single Use; Sterile Bone Cutting Burrs – ***REF MCA5-07SD; QTY: 1***0.7 mm Diamond Ball; 5.6 cm. Use with Micro Curved Attachment (MCA).***Sterilized using Irradiation***RX Only***ANSPACH Manufacturer***Made in USA***The Anspach Effort; Inc. 4500 Riverside Drive Palm Beach Gardens; FL 33410; USA Tel: (800) 327 6887 / + 1 561 627 1080***Anspach Europe Ltd. Aston Court; Kingsmead Business Park Frederick Place High Wycombe; HP 11 1LA United Kingdom Tel: +441494 616126******REF MCA7-07SD; QTY: 1***0.7 mm Diamond Ball; 7.3 cm. Use with Micro Curved Attachment (MCA).***Sterilized using Irradiation***RX Only***ANSPACH Manufacturer***Made in USA***The Anspach Effort; Inc. 4500 Riverside Drive Palm Beach Gardens; FL 33410; USA Tel: (800) 327 6887 / + 1 561 627 1080***Anspach Europe Ltd. Aston Court; Kingsmead Business Park Frederick Place High Wycombe; HP 11 1LA United Kingdom Tel: +441494 616126***Cutting and Shaping bone including bones of the spine and cranium | On July 30th; 2010 the Anspach Effort; Inc. initiated a voluntary recall on their Anspach Single Use; Sterile Bone Cutting Burrs. A complaint was recieved stating that the product had failed during a procedure. |
Aug-01-2011 | The Anspach Effort; Inc. | Anspach Single Use; Sterile Bone Cutting Burrs – ***REF MCA5-08SD; QTY: 1***0.8 mm Diamond Ball; 5.6 cm. Use with Micro Curved Attachment (MCA).***Sterilized using Irradiation***RX Only***ANSPACH Manufacturer***Made in USA***The Anspach Effort; Inc. 4500 Riverside Drive Palm Beach Gardens; FL 33410; USA Tel: (800) 327 6887 / + 1 561 627 1080***Anspach Europe Ltd. Aston Court; Kingsmead Business Park Frederick Place High Wycombe; HP 11 1LA United Kingdom Tel: +441494 616126******REF MCA7-08SD; QTY: 1***0.8 mm Diamond Ball; 7.3 cm. Use with Micro Curved Attachment (MCA).***Sterilized using Irradiation***RX Only***ANSPACH Manufacturer***Made in USA***The Anspach Effort; Inc. 4500 Riverside Drive Palm Beach Gardens; FL 33410; USA Tel: (800) 327 6887 / + 1 561 627 1080***Anspach Europe Ltd. Aston Court; Kingsmead Business Park Frederick Place High Wycombe; HP 11 1LA United Kingdom Tel: +441494 616126***Cutting and Shaping bone including bones of the spine and cranium | On July 30th; 2010 the Anspach Effort; Inc. initiated a voluntary recall on their Anspach Single Use; Sterile Bone Cutting Burrs. A complaint was recieved stating that the product had failed during a procedure. |
Aug-01-2011 | The Anspach Effort; Inc. | Anspach Single Use; Sterile Bone Cutting Burrs – "***REF MCA5-15SB QTY: 1***1.5 mm Fluted Ball; 5.6 cm. Use with Micro Curved Attachment (MCA).***Sterilized using Irradiation***RX Only***ANSPACH Manufacture The Anspach Effort; Inc. 4500 Riverside DrivePalm Beach Gardens; FL 33410; USA Tel: (800) 327 6887 / + 1 561 627 1080***Anspach Europe Ltd. Aston Court; Kingsmead Business Park Frederick Place High Wycombe; Hp 11 1LA United Kingdom Tel: +441494 616126***""***REF MCA7-15SB QTY: 1***1.5 mm Fluted Ball; 7.3 cm. Use with Micro Curved Attachment (MCA).***Sterilized using Irradiation***RX Only***ANSPACH Manufacture The Anspach Effort; Inc. 4500 Riverside DrivePalm Beach Gardens; FL 33410; USA Tel: (800) 327 6887 / + 1 561 627 1080***Anspach Europe Ltd. Aston Court; Kingsmead Business Park Frederick Place High Wycombe; Hp 11 1LA United Kingdom Tel: +441494 616126***"Cutting and Shaping bone including bones of the spine and cranium | On July 30th; 2010 the Anspach Effort; Inc. initiated a voluntary recall on their Anspach Single Use; Sterile Bone Cutting Burrs. A complaint was recieved stating that the product had failed during a procedure. |
Aug-01-2011 | The Anspach Effort; Inc. | Anspach Single Use; Sterile Bone Cutting Burrs – ***REF MCA5-15SD; QTY: 1***1.5 mm Diamond Ball; 5.6 cm. Use with Micro Curved Attachment (MCA).***Sterilized using Irradiation***RX Only***ANSPACH Manufacturer***Made in USA***The Anspach Effort; Inc. 4500 Riverside Drive Palm Beach Gardens; FL 33410; USA Tel: (800) 327 6887 / + 1 561 627 1080***Anspach Europe Ltd. Aston Court; Kingsmead Business Park Frederick Place High Wycombe; HP 11 1LA United Kingdom Tel: +441494 616126******REF MCA7-15SD; QTY: 1***1.5 mm Diamond Ball; 7.3 cm. Use with Micro Curved Attachment (MCA).***Sterilized using Irradiation***RX Only***ANSPACH Manufacturer***Made in USA***The Anspach Effort; Inc. 4500 Riverside Drive Palm Beach Gardens; FL 33410; USA Tel: (800) 327 6887 / + 1 561 627 1080***Anspach Europe Ltd. Aston Court; Kingsmead Business Park Frederick Place High Wycombe; HP 11 1LA United Kingdom Tel: +441494 616126***Cutting and Shaping bone including bones of the spine and cranium | On July 30th; 2010 the Anspach Effort; Inc. initiated a voluntary recall on their Anspach Single Use; Sterile Bone Cutting Burrs. A complaint was recieved stating that the product had failed during a procedure. |
Aug-02-2011 | Spacelabs Healthcare; Llc | Vital Sign elance Monitor; Model 93300 – Vital Sign elance Monitor; Model 93300Spacelabs Healthcare; Llc.A vital signs patient monitor with arrhythmia detection. | Model 93300 Vital Signs Monitor may stop operating while in use; and when this occurs; the monitor may also fail to power ON. The resulting situation may cause a loss of monitoring for the patient. |
Aug-03-2011 | Cardiac Science Corporation | Powerheart AED; G2 – Automated External Defibrillator (non-wearable). Model number 9200; 9200N; 9200DN; 9200RD; 9210N; 9210RD; and CardioVive 92530.The battery component is warranted for 5 years; and electrodes have a shelf life of 2 years.The Powerheart AED G2 and CardioVive 92530 are intended to acquire the ECG rhythm for the detection of; and to provide treatment for; ventricular tachyarrhythmias of patients who are at risk of sudden cardiac arrest. The device is intended to be used in medically supervised environments by trained personnel; in which patients are under the direct care of physicians and/or medical persons authorized by the state; province; or country regulations in which they practice. | Cardiac Science Corporation (CSC) intent to end service support and discontinue accessory sales of Powerheart G2 Automated External Defibrillators. Customers are recommended to choose a replacement AED prior to the current AED displaying any "Service Required" self test messages. |
Aug-03-2011 | Baxter Healthcare Corp. | Baxter Solution Set with Duo-Vent Spike – Baxter Solution Set with Duo-Vent Spike; 109" (2.8 m); Male Luer Lock Adapter 10 drops/mL.Baxter Healthcare Corporation.A sterile; single use; nonpyrogenic fluid pathway for use with rigid nonvented and flexible containers. | The Solution Sets are being recalled because the position of the slide clamp and roller clamp may have been reversed during assembly. The reversed orientation of the slide clamp and roller clamp will cause the set to be incorrectly loaded into an infusion pump; resulting in fluid flow from the patient to the pump; rather than from the pump to the patient. |
Aug-03-2011 | Stryker Medical Division of Stryker Corporation | Stryker Medical 1105 Prime 5th Wheel – Stryker Medical Stretcher Model 1105 Prime 5th WheelA wheeled stretcher consists of a platform mounted on a wheeled frame that is designed to transport patients in a horizontal position. The device has siderails and supports for fluid infusion equipment. | Stryker Medical has determined that some Prime Brake Pad Assembly components were manufactured with brake shoes that did not meet specifications. Accordingly some brake shoes used within the Prime Brake Pad Assembly may wear prematurely; over the life of the product. Reduced braking force may result in a patient fall or caregiver muscle strain; either of which may require medical intervention. |
Aug-03-2011 | Intuitive Surgical; Inc. | Intuitive Surgical da Vinci Si Surgical System (IS3000) – Intuitive Surgical da Vinci Si Surgical System (IS3000);Mfg by: Intuitive Surgical; Sunnyvale; CA 94086Product Usage: Intended to assist in the accurate control of Intuitive Surgical Endoscopic Endo Wrist Instruments and Accessories. The system is indicated for adult and pediatric use (except for transoral otolaryngology surgical procedures). It is intended for use for trained physicians in an operating room environment in accordance with the representative; specific procedures set forth in the Professional Instructions for Use. | Potential failure of the retention component of the Master Tool Manipulator (MTM) of the Intuitive Surgical da Vinci Si Surgical System which could cause uncontrolled movement. |
Aug-03-2011 | Stryker Medical Division of Stryker Corporation | Stryker Medical 1115 Prime Big Wheel – Stryker Medical Stretcher Model 1115 Prime Big WheelA wheeled stretcher consists of a platform mounted on a wheeled frame that is designed to transport patients in a horizontal position. The device has siderails and supports for fluid infusion equipment. | Stryker Medical has determined that some Prime Brake Pad Assembly components were manufactured with brake shoes that did not meet specifications. Accordingly some brake shoes used within the Prime Brake Pad Assembly may wear prematurely; over the life of the product. Reduced braking force may result in a patient fall or caregiver muscle strain; either of which may require medical intervention. |
Aug-03-2011 | Stryker Medical Division of Stryker Corporation | 1125 Prime Zoom Stryker Medical Stretcher – 1125 Prime Zoom Stryker Medical StretcherA wheeled stretcher consists of a platform mounted on a wheeled frame that is designed to transport patients in a horizontal position. The device has siderails and supports for fluid infusion equipment. | Stryker Medical has determined that some Prime Brake Pad Assembly components were manufactured with brake shoes that did not meet specifications. Accordingly some brake shoes used within the Prime Brake Pad Assembly may wear prematurely; over the life of the product. Reduced braking force may result in a patient fall or caregiver muscle strain; either of which may require medical intervention. |
Aug-03-2011 | Stryker Medical Division of Stryker Corporation | Stryker Medical Stretcher Model 748 Transport – Stryker Medical Stretcher Model 748 TransportA wheeled stretcher consists of a platform mounted on a wheeled frame that is designed to transport patients in a horizontal position. The device has siderails and supports for fluid infusion equipment. | Stryker Medical has determined that some Prime Brake Pad Assembly components were manufactured with brake shoes that did not meet specifications. Accordingly some brake shoes used within the Prime Brake Pad Assembly may wear prematurely; over the life of the product. Reduced braking force may result in a patient fall or caregiver muscle strain; either of which may require medical intervention. |
Aug-03-2011 | Stryker Medical Division of Stryker Corporation | Stryker Medical 1037 Trauma – Stryker Medical Stretcher Model 1037 TraumaA wheeled stretcher consists of a platform mounted on a wheeled frame that is designed to transport patients in a horizontal position. The device has siderails and supports for fluid infusion equipment. | Stryker Medical has determined that some Prime Brake Pad Assembly components were manufactured with brake shoes that did not meet specifications. Accordingly some brake shoes used within the Prime Brake Pad Assembly may wear prematurely; over the life of the product. Reduced braking force may result in a patient fall or caregiver muscle strain; either of which may require medical intervention. |
Aug-03-2011 | Stryker Medical Division of Stryker Corporation | Stryker Medical Stretcher Model 1089 Eye Surgery – Stryker Medical Stretcher Model 1089 Eye SurgeryA wheeled stretcher consists of a platform mounted on a wheeled frame that is designed to transport patients in a horizontal position. The device has siderails and supports for fluid infusion equipment. | Stryker Medical has determined that some Prime Brake Pad Assembly components were manufactured with brake shoes that did not meet specifications. Accordingly some brake shoes used within the Prime Brake Pad Assembly may wear prematurely; over the life of the product. Reduced braking force may result in a patient fall or caregiver muscle strain; either of which may require medical intervention. |
Aug-03-2011 | Stryker Medical Division of Stryker Corporation | Stryker Medical Stretcher Model 747 Transport – Stryker Medical Stretcher Model 747 TransportA wheeled stretcher consists of a platform mounted on a wheeled frame that is designed to transport patients in a horizontal position. The device has siderails and supports for fluid infusion equipment. | Stryker Medical has determined that some Prime Brake Pad Assembly components were manufactured with brake shoes that did not meet specifications. Accordingly some brake shoes used within the Prime Brake Pad Assembly may wear prematurely; over the life of the product. Reduced braking force may result in a patient fall or caregiver muscle strain; either of which may require medical intervention. |
Aug-03-2011 | Boston Scientific Corporation | Pinnacle Pelvic Floor Repair Kit–Anterior/Apical; and Pinnacle Pelvic Floor Repair Kit–Posterior – Pinnacle Pelvic Floor Repair Kit–Anterior/Apical STERILE; and Pinnacle Pelvic Floor Repair Kit–Posterior STERILE.Boston Scientific; Corp.Indicated for tissue reinforcement and stabilization of fascial structures of the pelvic floor for vaginal wall prolapse; where surgical treatment is intended; either as mechanical support or bridging material for the fascial defect. | The device may exhibit low tensile strength between the needle and suture and lead to needle detachment during mesh leg placement. |
Aug-03-2011 | Teleflex Medical | RUSCH – RUSCH; GB: Female Catheter; All Purpose PVC; 08 Fr. 18 cm; Distributed by Teleflex Medical; Research Triangle Park; NCProduct Usage: Catheter that is inserted through the urethra and used to pass fluids to or from the urinary tract. | Pin holes were detected in the packaging therefore sterility of the device can not be guaranteed. |
Aug-03-2011 | Teleflex Medical | RUSCH – RUSCH; GB: Robinson/Nelaton Catheter; All Purpose PVC 40 Fr. 40 cm; Distributed by Teleflex Medical; Research Triangle Park; NC.Product Usage: Catheter that is inserted through the urethra and used to pass fluids to or from the urinary tract. | Pin holes were detected in the packaging therefore sterility of the device can not be guaranteed. |
Aug-03-2011 | Teleflex Medical | RUSCH – RUSCH; GB: Robinson/Nelaton Catheter; All Purpose PVC 22 Fr. 40 cm; Distributed by Teleflex Medical; Research Triangle Park; NC.Product Usage: Catheter that is inserted through the urethra and used to pass fluids to or from the urinary tract. | Pin holes were detected in the packaging therefore sterility of the device can not be guaranteed. |
Aug-03-2011 | Teleflex Medical | RUSCH – RUSCH; GB: Robinson/Nelaton Catheter; All Purpose PVC 20 Fr. 40 cm; Distributed by Teleflex Medical; Research Triangle Park; NCProduct Usage: Catheter that is inserted through the urethra and used to pass fluids to or from the urinary tract. | Pin holes were detected in the packaging therefore sterility of the device can not be guaranteed. |
Aug-03-2011 | Teleflex Medical | RUSCH – RUSCH; GB: Female Catheter; All Purpose PVC; 10 Fr. 18 cm; Distributed by Teleflex Medical; Research Triangle Park; NCProduct Usage: Catheter that is inserted through the urethra and used to pass fluids to or from the urinary tract. | Pin holes were detected in the packaging therefore sterility of the device can not be guaranteed. |
Aug-03-2011 | Teleflex Medical | RUSCH – RUSCH; GB: Female Catheter; All Purpose PVC; 12 Fr. 18 cm; Distributed by Teleflex Medical; Research Triangle Park; NCProduct Usage: Catheter that is inserted through the urethra and used to pass fluids to or from the urinary tract. | Pin holes were detected in the packaging therefore sterility of the device can not be guaranteed. |
Aug-03-2011 | Teleflex Medical | RUSCH – RUSCH; GB: Female Catheter; All Purpose PVC; 14 Fr. 18 cm; Distributed by Teleflex Medical; Research Triangle Park; NCProduct Usage: Catheter that is inserted through the urethra and used to pass fluids to or from the urinary tract. | Pin holes were detected in the packaging therefore sterility of the device can not be guaranteed. |
Aug-03-2011 | Teleflex Medical | RUSCH – RUSCH; GB: Female Catheter; All Purpose PVC; 16 Fr. 18 cm; Distributed by Teleflex Medical; Research Triangle Park; NCProduct Usage: Catheter that is inserted through the urethra and used to pass fluids to or from the urinary tract. | Pin holes were detected in the packaging therefore sterility of the device can not be guaranteed. |
Aug-03-2011 | Teleflex Medical | RUSCH – RUSCH; GB: Robinson/Nelaton Catheter; All Purpose PVC 10 Fr. 40 cm; Distributed by Teleflex Medical; Research Triangle Park; NCProduct Usage: Catheter that is inserted through the urethra and used to pass fluids to or from the urinary tract. | Pin holes were detected in the packaging therefore sterility of the device can not be guaranteed. |
Aug-03-2011 | Teleflex Medical | RUSCH – RUSCH; GB: Robinson/Nelaton Catheter; All Purpose PVC 12 Fr. 40 cm; Distributed by Teleflex Medical; Research Triangle Park; NC.Product Usage: Catheter that is inserted through the urethra and used to pass fluids to or from the urinary tract. | Pin holes were detected in the packaging therefore sterility of the device can not be guaranteed. |
Aug-03-2011 | Teleflex Medical | RUSCH – RUSCH; GB: Robinson/Nelaton Catheter; All Purpose PVC 14 Fr. 40 cm; Distributed by Teleflex Medical; Research Triangle Park; NCProduct Usage: Catheter that is inserted through the urethra and used to pass fluids to or from the urinary tract. | Pin holes were detected in the packaging therefore sterility of the device can not be guaranteed. |
Aug-03-2011 | Teleflex Medical | RUSCH – RUSCH; GB: Robinson/Nelaton Catheter; All Purpose PVC 16 Fr. 40 cm; Distributed by Teleflex Medical; Research Triangle Park; NC.Product Usage: Catheter that is inserted through the urethra and used to pass fluids to or from the urinary tract. | Pin holes were detected in the packaging therefore sterility of the device can not be guaranteed. |
Aug-03-2011 | Teleflex Medical | RUSCH – RUSCH; GB: Robinson/Nelaton Catheter; All Purpose PVC 18 Fr. 40 cm; Distributed by Teleflex Medical; Research Triangle Park; NC.Product Usage: Catheter that is inserted through the urethra and used to pass fluids to or from the urinary tract. | Pin holes were detected in the packaging therefore sterility of the device can not be guaranteed. |
Aug-03-2011 | Remel Inc | remel Haemophilus Test Medium (Agar) – remel Haemophilus Test Medium (Agar); 100mm plates; 10/pk; Ref. #R01503. The firm name on the label is Remel; Lenexa; KS.For use in qualitative procedures by the Clinical and Laboratory Standards Institute (CLSI) as the growth medium for antimicrobial disk diffusion tests with Haemophilus species. | Organism strains may fail to consistently produce confluent growth |
Aug-03-2011 | Remel Inc | remel Haemophilus Test Medium (Agar) – remel Haemophilus Test Medium (Agar); 150mm plates; 10/pk; Ref. #R04033. The firm name on the label is Remel; Lenexa; KS.For use in qualitative procedures by the Clinical and Laboratory Standards Institute (CLSI) as the growth medium for antimicrobial disk diffusion tests with Haemophilus species. | Organism strains may fail to consistently produce confluent growth |
Aug-03-2011 | Welch Allyn Protocol; Inc | Aruba Wireless Access Points; Model 65 – Aruba Wireless Network Access Points; Model 65 utilized by the Acuity Central Monitoring System.Welch Allyn Protocol; Inc.Intended for use by clinicians for the central monitoring of neonatal; pediatric and adult patients in health care facilities. The system connects to a network of patient monitors to record and analyze physiological data being acquired by the monitors. | Aruba Wireless Network Access Points; Model Number 65; experienced a higher than expected incidence of dropouts due to external RF interference. |
Aug-03-2011 | Computerized Medical Systems Inc | XiO Radiation Treatment Planning System – XiO Radiation Treatment Planning System; XiO versions equal to or greater than 2.4.0 and less than 4.63.0The XiO RTP System is used to create treatment plans for any cancer patient for whom external beam radiation therapy or brachytherapy has been prescribed. | The XiO Software currently prompts for entry of CT to ED data for a studyset. No indication is given that the Electron Density data should only be used for Photon and Electron calculations and either Relative Stopping Power or Mass Density should be used for Proton calculations (depending on the algorithm). |
Aug-04-2011 | Spectranetics Corporation | Laser Guide Catheter – Spectranetics Turbo-Booster Laser Guide Catheter; 7 Fr; REF 518-043; Sterile EO; Spectranetics Corporation; 96 Talamine Court; Colorado Springs; CO 80907.Designed for directing and supporting Spectranetics laser catheters for use in the treatment of infrainguinal stenoses and occlusions. | Packaging integrity may be compromised; thus sterility can not be assured. |
Aug-04-2011 | Spectranetics Corporation | Laser Guide Catheter – Spectranetics Turbo-Booster Laser Guide Catheter; 8 Fr; REF 518-063; Sterile EO; Spectranetics Corporation; 96 Talamine Court; Colorado Springs; CO 80907.Designed for directing and supporting Spectranetics laser catheters for use in the treatment of infrainguinal stenoses and occlusions. | Packaging integrity may be compromised; thus sterility can not be assured. |
Aug-04-2011 | Terumo Cardiovascular Corporation | CAPIOX Flexible Venous Reservoir – CAPIOX¿ Flexible Venous Reservoirs; 1500 mL; product codes: CXFVR1500X and CXFVRI500XC; used singly or packaged as components in cardiovascular procedure trays labeled in part ***Terumo Caerdiovascular Systems Corporation; Elkton; MD 21921***Product Usage: The reservoir bag is intended for use as a blood collection and storage device during cardiopulmonary bypass procedures. The device is intended for use in conjunction with blood-gas oxygenators in the extra-corporeal circuit. The device may be used in procedures lasting up to 6 hours. | Reservoir blood bag used in cardiovascular procedures may leak. |
Aug-04-2011 | Vascular Solutions; Inc. | Vascular Solutions; Pronto¿ V4; Extraction Catheter – Vascular Solutions; Pronto¿ V4; Extraction Catheter; Sterilized using ethylene oxide; Rx Only. The following sizes/model numbers are affected: 5.5F( 4005); 6F(4006; 7F(4007; 8F(4008) are involved in the recall.The Pronto catheter is indicated for the removal of fresh; soft emboli and thrombi from vessels in the coronary and peripheral vasculature. | Vascular Solutions ; Inc recently discovered that there was a manufacturing defect with Pronto V4 extraction catheters (Models 4005; 4006; 4007; 4008). Use of this defective product could lead to a tip separation. This maycause injury and/or procedural delay; resulting in a deteriorating hemodynamic condition of the patientwhich may require medical intervention. |
Aug-04-2011 | Philips Medical Systems | BrightView XCT Gamma Camera; 3/8". – BrightView XCT Gamma Camera; 3/8".Philips Medical Systems; Inc.Intended to produce images depicting the anatomical distributions of single photon emitting radioisotopes within the human body for interpretation by medical personnel. | Non-conformances with BrightView X/XCT systems running version 2.0.1 including data transfer; XCT acquisition; Pixel Mask for image reconstruction and table moving incorrectly. |
Aug-04-2011 | Philips Medical Systems | BrightView X Gamma Camera; 3/8". – BrightView X Gamma Camera; 3/8".Philips Medical Systems; Inc.Intended to produce images depicting the anatomical distributions of single photon emitting radioisotopes within the human body for interpretation by medical personnel. | Non-conformances with BrightView X/XCT systems running version 2.0.1 including data transfer; XCT acquisition; Pixel Mask for image reconstruction and table moving incorrectly. |
Aug-04-2011 | Philips Medical Systems | BrightView XCT Gamma Camera; 3/4". – BrightView XCT Gamma Camera; 3/4".Philips Medical Systems; Inc.Intended to produce images depicting the anatomical distributions of single photon emitting radioisotopes within the human body for interpretation by medical personnel. | Non-conformances with BrightView X/XCT systems running version 2.0.1 including data transfer; XCT acquisition; Pixel Mask for image reconstruction and table moving incorrectly. |
Aug-04-2011 | Biomet; Inc. | Vanguard PS Open Box Femoral 70MM Left Interlok – Vanguard PS Open Box Femoral 70 MM Left Interlock; " FOR CEMENTED USE ONLY" CO-CR-MO ALLOY.Biomet; Inc.A knee joint replacement prosthesis non-coated femoral indicated for cemented application only. | The recalled device was manufactured with two distal pegs but package labeling indicates the device is pegless. |
Aug-05-2011 | Haemonetics Corporation | Haemonetics cardioPAT -Cardiovascular Perioperative Autotransfusion System – Haemonetics cardioPAT -Cardiovascular Perioperative Autotransfusion SystemModel 2050 USModels Out-Side the US:02050-UK; 02050-ES; 02050-IT; 02050-NL; 02050-GE; 02050-FR; 02050-JAThe Haemonetics¿ Cardiovascular Perioperative Autotransfusion Systemfor Use (cardioPAT) is indicated for use to salvage red blood cells from blood lost intraoperatively and postoperatively during cardiovascular surgicalprocedures; where the expected rate of processing of salvaged blood and fluidaspirated from the surgical site is less than or equal to two liters per hour. | Updated Operations Manual for the deployment of the spill collection system and cleaning |
Aug-05-2011 | St. Jude Medical | Supreme Electrophysiology Extension Cable – Supreme Electrophysiology Extension Cable; REF 401984; For use with Hexapolar Catheters; Sterile EO; Rx only; St Jude Medical; 14901 DeVeau Place; Minnetonka; MN 55345.Supreme Electrophysiology Extension Cable used to connect Electrophysiology catheters to external diagnostic or therapeutic equipment. The section indexing connector located a t the distal end of the cable will only connect to SMJ Electrophysiology catheters. | St. Jude Medical is recalling a single lot (3334664) of Supreme Electrophysiology Extension Cable which were packaged with a Quadripolar cable instead of a hexapolar Cable. St. Jude Medical has determined that the incorrectly labeled product poses no safety risk since the extension cable can be safely used with a corresponding Quadripolar catheter but cannot be incorrectly connected to a Hexap |
Aug-05-2011 | International Technidyne Corp. | Hemochron JR. Microcoagulation Systems Prothrombin Time (PT). – Hemochron JR. Microcoagulation Systems Prothrombin Time (PT). International Ethidine Corp (ITC)-Nexus Dx.A unitized mlcrocoagulation test intended for use in performing one-stage prothrombin time. | Certain lots of Hemochron Jr. PT Cuvettes (J201) demonstrate a higher bias than historically observed when compared to laboratory reference instruments. |
Aug-05-2011 | International Technidyne Corp. | IL GEM PCL/PCL Plus – Gem Test PT Cartridge – IL GEM PCL/PCL Plus – Gem Test PT CartridgeITC-Nexus Dx A unitized mlcrocoagulation test intended for use in performing one-stage prothrombin time. | Certain lots of Hemochron Jr. PT Cuvettes (J201) and GEM Test PT cartridges demonstrate a higher bias than historically observed when compared to laboratory reference. instruments. |
Aug-08-2011 | Baxter Healthcare Corp. | Colleague CX Infusion Pump – Baxter Colleague CX Infusion Pump; Single Channel Volumetric Infusion Pumps. Baxter Healthcare Corporation; Medication Delivery Division; Deerfield; IL 60015. Product Code: 2M8161. Product Usage: Intended for use in a wide variety of patient environments for adult; pediatric and neonatal patients. Electronic infusion pumps indicated for continuous or intermittent delivery of solution through clinically acceptable routes of administration; such as intravenous (IV); intra-arterial (IA); subcutaneous; epidural or irrigation of fluid spaces applications. | Baxter’s Service Center tested and returned to the user the Colleague infusion pump that did not meet PSIG (Pounds-force per Square Inch) specifications |
Aug-08-2011 | Greiner Bio-One North America; Inc. | HOLDEX Single-Use Holder PP – HOLDEX Single-Use Holder PP closed pack. Greiner Bio-One Austria Gmbh. A sterile single-use disposable holder with an off-center female luer at the top of the holder and epoxy bonded stainless steel needle on the underside of the holder; recommended for use with commercially available butterfly and luer needles in routine venipuncture procedures. | At removal of the tube from the holder; the needle may dislodge and blood spill can occur. |
Aug-09-2011 | Haag-Streit USA Inc | Lenstar LS 900 EyeSuite Biometry version i2.000; – Lenstar LS 900 EyeSuite Biometry version i2.000; Four (4) Protective Cardboard Containers Per Each System.Haag-Streit USA; Inc.A non-invasive; non-contact OLCR (Optical Low Coherence Reflectometer) Biometer used for obtaining ocular measurements and performing calculations to assist in determination of the appropriate power and type of IOL (Intraocular Lens) for implantation after removal of the natural crystalline lens following cataract removal. | A patient record may be linked to an incorrect/inconsistent set of calculation results under specific circumstances when using EyeSuite Software version i2.000. |
Aug-09-2011 | AMO Manufacturing USA; LLC | STAR S4 IR Excimer Laser System; Software Version 5.01 – STAR S4 IR Excimer Laser System; Software Version 5.01Mfg by : AMO Manufacturing USA; LLC510 Cottonwood DriveMilpitas; CA 95035Iris registration is designed to compensate for pupil centroid shift and cycloration; both of Which may occur because of patient characteristics and the different environments at the time of measurement and at the time of treatment. | Reports of lower success rates with Iris Registration (IR) image capture with the STAR S4 IR Excimer Laser System v 5.3 that with previous version. |
Aug-09-2011 | AMO Manufacturing USA; LLC | STAR S4 IR Excimer Laser System; Software Version 5.02 – STAR S4 IR Excimer Laser System; Software Version 5.02Mfg by : AMO Manufacturing USA; LLC510 Cottonwood DriveMilpitas; CA 95035Iris registration is designed to compensate for pupil centroid shift and cycloration; both of Which may occur because of patient characteristics and the different environments at the time of measurement and at the time of treatment. | Reports of lower success rates with Iris Registration (IR) image capture with the STAR S4 IR Excimer Laser System v 5.3 that with previous version. |
Aug-09-2011 | AMO Manufacturing USA; LLC | STAR S4 IR Excimer Laser System; Software Version 5.10 – STAR S4 IR Excimer Laser System; Software Version 5.10Mfg by : AMO Manufacturing USA; LLC510 Cottonwood DriveMilpitas; CA 95035Iris registration is designed to compensate for pupil centroid shift and cycloration; both of Which may occur because of patient characteristics and the different environments at the time of measurement and at the time of treatment. | Reports of lower success rates with Iris Registration (IR) image capture with the STAR S4 IR Excimer Laser System v 5.3 that with previous version. |
Aug-09-2011 | AMO Manufacturing USA; LLC | STAR S4 IR Excimer Laser System; Software Version 5.15 – STAR S4 IR Excimer Laser System; Software Version 5.15Mfg by : AMO Manufacturing USA; LLC510 Cottonwood DriveMilpitas; CA 95035Iris registration is designed to compensate for pupil centroid shift and cycloration; both of Which may occur because of patient characteristics and the different environments at the time of measurement and at the time of treatment. | Reports of lower success rates with Iris Registration (IR) image capture with the STAR S4 IR Excimer Laser System v 5.3 that with previous version. |
Aug-09-2011 | AMO Manufacturing USA; LLC | STAR S4 IR Excimer Laser System; Software Version 5.18 – STAR S4 IR Excimer Laser System; Software Version 5.18Mfg by : AMO Manufacturing USA; LLC510 Cottonwood DriveMilpitas; CA 95035Iris registration is designed to compensate for pupil centroid shift and cycloration; both of Which may occur because of patient characteristics and the different environments at the time of measurement and at the time of treatment. | Reports of lower success rates with Iris Registration (IR) image capture with the STAR S4 IR Excimer Laser System v 5.3 that with previous version. |
Aug-09-2011 | AMO Manufacturing USA; LLC | STAR S4 IR Excimer Laser System; Software Version 5.20 – STAR S4 IR Excimer Laser System; Software Version 5.20Mfg by : AMO Manufacturing USA; LLC510 Cottonwood DriveMilpitas; CA 95035Iris registration is designed to compensate for pupil centroid shift and cycloration; both of Which may occur because of patient characteristics and the different environments at the time of measurement and at the time of treatment. | Reports of lower success rates with Iris Registration (IR) image capture with the STAR S4 IR Excimer Laser System v 5.3 that with previous version. |
Aug-09-2011 | AMO Manufacturing USA; LLC | STAR S4 IR Excimer Laser System; Software Version 5.21 – STAR S4 IR Excimer Laser System; Software Version 5.21Mfg by : AMO Manufacturing USA; LLC510 Cottonwood DriveMilpitas; CA 95035Iris registration is designed to compensate for pupil centroid shift and cycloration; both of Which may occur because of patient characteristics and the different environments at the time of measurement and at the time of treatment. | Reports of lower success rates with Iris Registration (IR) image capture with the STAR S4 IR Excimer Laser System v 5.3 that with previous version. |
Aug-09-2011 | AMO Manufacturing USA; LLC | STAR S4 IR Excimer Laser System; Software Version 5.22 – STAR S4 IR Excimer Laser System; Software Version 5.22Mfg by : AMO Manufacturing USA; LLC510 Cottonwood DriveMilpitas; CA 95035Iris registration is designed to compensate for pupil centroid shift and cycloration; both of Which may occur because of patient characteristics and the different environments at the time of measurement and at the time of treatment. | Reports of lower success rates with Iris Registration (IR) image capture with the STAR S4 IR Excimer Laser System v 5.3 that with previous version. |
Aug-09-2011 | AMO Manufacturing USA; LLC | STAR S4 IR Excimer Laser System; Software Version 5.30 – STAR S4 IR Excimer Laser System; Software Version 5.30Mfg by : AMO Manufacturing USA; LLC510 Cottonwood DriveMilpitas; CA 95035Iris registration is designed to compensate for pupil centroid shift and cycloration; both of Which may occur because of patient characteristics and the different environments at the time of measurement and at the time of treatment. | Reports of lower success rates with Iris Registration (IR) image capture with the STAR S4 IR Excimer Laser System v 5.3 that with previous version. |
Aug-09-2011 | AMO Manufacturing USA; LLC | STAR S4 IR Excimer Laser System; Software Version 5.00 – STAR S4 IR Excimer Laser System; Software Version 5.00Mfg by : AMO Manufacturing USA; LLC510 Cottonwood DriveMilpitas; CA 95035Iris registration is designed to compensate for pupil centroid shift and cycloration; both of Which may occur because of patient characteristics and the different environments at the time of measurement and at the time of treatment. | Reports of lower success rates with Iris Registration (IR) image capture with the STAR S4 IR Excimer Laser System v 5.3 that with previous version. |
Aug-09-2011 | AMO Manufacturing USA; LLC | STAR S4 IR Excimer Laser System; Software Version 5.16 – STAR S4 IR Excimer Laser System; Software Version 5.16Mfg by : AMO Manufacturing USA; LLC510 Cottonwood DriveMilpitas; CA 95035Iris registration is designed to compensate for pupil centroid shift and cycloration; both of Which may occur because of patient characteristics and the different environments at the time of measurement and at the time of treatment. | Reports of lower success rates with Iris Registration (IR) image capture with the STAR S4 IR Excimer Laser System v 5.3 that with previous version. |
Aug-10-2011 | Philips Healthcare Inc. | Philips Medical Allura Xper Systems – Allura Xper Systems Models:Allura Xper FD10 (F/C)-Biplane Fixed Allura Xper FD10/10 (incl. OR table)Allura Xper FD20- High resolution fixed-x rayAllura Xper FD20/10Allura Xper FD20/20Allura CV20The Allura Xper F010; FD10/10; FD20; FD20/10 and FD20/20 Use From Labeling): is intended for use in cardiovascular and vascular X-ray imaging applications. including diagnostic;interventional procedures (such as PTCA; stent placement and atherectomies); pacemaker implantations and ElectroPhysiology (EP). The Allura Xper is intended for: Dedicated vascular and neurovascular imaging applications; including diagnostic and interventional procedures. This includes; e.g. peripheral; cerebral. thoracic and abdominal angiography; as well as PTCAs. stent placements; embolisations and thrombolysis. and Cardiac imaging applications including diagnostics; interventional procedures (such as PTCA; stent placing; atherectomies); pacemaker implantations and Electrophysiology (EP). Non-vascular interventions such as drainages; biopsies and vertebroplasties procedures. Use of the Allura Xper FD Series in the OR environment is restricted; the system should only be used for minimally invasive procedures. (Endovascular) | System freezes from 20 seconds up to one minute. No fluoroscopy exposure and no geometry movements during this time period. |
Aug-10-2011 | North Coast Medi-Tek Inc | North Coast Medi-Tek Inc Biopsy Trays – Biopsy Trays (CT; Puncture & Prep); Packaged individually in header bags; 10 per case.Sterile; Disposable Convenience Kits used for diagnostic radiology procedures. A diagnostic radiology kit used in CT and general biopsies | During routine bioburden testing; unusually high results were found for a Bioburden Test done on 4/19/11. Bioburden Level reported as >150;000 CFU. Our Alert Level is 17;000 CFU and the Action Level is 23;000 CFU. |
Aug-10-2011 | Applied Medical Resources Corp | Direct Drive Grasper – Direct Drive Grasper; VARIOUS KITS CONTAINING EITHER C4130OR C4140Intended Usage: The grasper is indicated for grasping and manipulating tissue during general or laparoscopic surgery. The instrument is not intended for use when minimally invasive techniques are contraindicated. Complications which have been reported secondary to surgical grasping and manipulation include; but are not limited to: local trauma; injury; and tissue necrosis. | The recall was initiated because Applied Medical has confirmed specific lot numbers of the DirectDrive? Grasper (model numbers C4130 and C4140) due to a potential weakness in the locking trigger; which could result in the trigger fracturing and the jaw locking in the closed position. |
Aug-10-2011 | Applied Medical Resources Corp | Direct Drive Grasper – Direct Drive Grasper; Model number C4140; 5MM X 45CM DIRECT DRIVEGRASPER 10/BXIntended Usage: The grasper is indicated for grasping and manipulating tissue during general or laparoscopic surgery. The instrument is not intended for use when minimally invasive techniques are contraindicated. Complications which have been reported secondary to surgical grasping and manipulation include; but are not limited to: local trauma; injury; and tissue necrosis. | The recall was initiated because Applied Medical has confirmed specific lot numbers of the DirectDrive? Grasper (model numbers C4130 and C4140) due to a potential weakness in the locking trigger; which could result in the trigger fracturing and the jaw locking in the closed position. |
Aug-10-2011 | Applied Medical Resources Corp | Direct Drive Grasper – Direct Drive Grasper; Model numbers C4130; 5MM X 35CM DIRECT DRIVE GRASPER 10/BXIntended Usage: The grasper is indicated for grasping and manipulating tissue during general or laparoscopic surgery. The instrument is not intended for use when minimally invasive techniques are contraindicated. Complications which have been reported secondary to surgical grasping and manipulation include; but are not limited to: local trauma; injury; and tissue necrosis. | The recall was initiated because Applied Medical has confirmed specific lot numbers of the DirectDrive? Grasper (model numbers C4130 and C4140) due to a potential weakness in the locking trigger; which could result in the trigger fracturing and the jaw locking in the closed position. |
Aug-10-2011 | Medtronic Sofamor Danek USA Inc | ATLANTIS(R) Anterior Cervical Plate System Screw Caddy; Self Drilling Fixed Screw Caddy – ATLANTIS(R) Anterior Cervical Plate System Screw Caddy; Self Drilling Fixed Screw Caddy (976-516).Medtronic Sofamor Danek USA; Inc.This instrument is a precision device which incorporates a measuring function. | Lines on the screw gauge may not placed on the caddy properly which could result in improper measurement of screws. |
Aug-10-2011 | Medtronic Sofamor Danek USA Inc | ATLANTIS(R) Anterior Cervical Plate System Screw Caddy; Self Tapping Variable Screw Caddy – ATLANTIS(R) Anterior Cervical Plate System Screw Caddy; Self Tapping Variable Screw Caddy (176-513).Medtronic Sofamor Danek USA; Inc.This instrument is a precision device which incorporates a measuring function. | Lines on the screw gauge may not placed on the caddy properly which could result in improper measurement of screws. |
Aug-10-2011 | Varian Medical Systems; Inc. Oncology Systems | GammaMed Plastic Needle with Mandrin – GammaMed Plastic Needle with Mandrin; 2.0mm diameter; length 200 mm.Remote controlled radionuclide applicator system.Varian Medical Systems; Inc.Mfg by Varian Medical Systems Haan GmbH; Haan; GermanyProduct Usage: The Interstitial Plastic Needles with 2 mm diameter are designed for interstitial treatments in areas such as head and neck; gynecology; breast or prostate. In order to avoid bending and to facilitate the introduction of the needles each needle is supplied with a Mandrin | Needle tip may separate from the needle shaft such that the tip may detach in the patient upon withdrawal. |
Aug-10-2011 | Varian Medical Systems; Inc. Oncology Systems | GammaMed Plastic Needle with Mandrin – GammaMed Plastic Needle with Mandrin; 2.0mm diameter; length 320 mm.Remote controlled radionuclide applicator system.Varian Medical Systems; Inc.Mfg by Varian Medical Systems Haan GmbH; Haan; GermanyProduct Usage: The Interstitial Plastic Needles with 2 mm diameter are designed for interstitial treatments in areas such as head and neck; gynecology; breast or prostate. In order to avoid bending and to facilitate the introduction of the needles each needle is supplied with a Mandrin | Needle tip may separate from the needle shaft such that the tip may detach in the patient upon withdrawal. |
Aug-10-2011 | Varian Medical Systems; Inc. Oncology Systems | GammaMed Plastic Needle with Mandrin – GammaMed Plastic Needle with Mandrin; 2.0mm diameter; length 113 mm.Remote controlled radionuclide applicator system.Varian Medical Systems; Inc.Mfg by Varian Medical Systems Haan GmbH; Haan; GermanyProduct Usage: The Interstitial Plastic Needles with 2 mm diameter are designed for interstitial treatments in areas such as head and neck; gynecology; breast or prostate. In order to avoid bending and to facilitate the introduction of the needles each needle is supplied with a Mandrin | Needle tip may separate from the needle shaft such that the tip may detach in the patient upon withdrawal. |
Aug-10-2011 | Carl Zeiss Meditec; Inc. | INTRABEAM Shielding Material – INTRABEAM Shielding Material Flat 20 x 20 cm; Sterile/FO0.05 mm Pb Equivalent (50keV)Carl Zeiss Meditec AGIndicated for radiation therapy treatments. | Carl Zeiss Meditec received a report that the INTRABEAM 20 x 20 cm sterile shield’s packaging looked wet inside. Investigation found the substance to be Triethylene Glycol; |
Aug-10-2011 | Siemens Medical Solutions USA; Inc | IMPAC / Elekta Medicals Sequencer – LANTIS Oncology Information System (OIS) Manufactured by IMPAC/Elekta medical as Multi -Access OIS for Siemens.An oncology digital imaging information management system. Lantis OIS in combination with Sequencer and a non-Siemens linac interface.System components include: LANTIS Commander; LANTIS system; LANTIS 6.1 Commander; LANTIS 8.3 Commander.Subcomponents include: Linac Interface; other vendor; LANTIS Varian Clinac; LANTIS GE Saturn; LANTIS Philips SLS;LANTIS Philips 75 ASU; LANTIS Elekta (Philips) and LANTIS Varian EX I/F. | A potential safety issue exists for data transfer between LANTIS OIS system (containing PRIMEVIEW or PRIMEVIEW Data Gateway) and the Sequencer V&R system via a third party interface is used. |
Aug-10-2011 | Sunrise Medical HHG Inc. dba DeVilbiss Healthcare | DeVilbiss Model DV5x Series CPAP with Heated Humidifier – DeVilbiss Model DV5x Series CPAP with Heated HumidifierDevice is intended to treat Obstructive Sleep Apnea (OSA) in patients weighing 30 Kg and above. The device creates a positive pressure in the patient’s airway to prevent collapse of the airway while the patient is sleeping. The heated humidifier provides additional humidity to the air supplied to the patient. The heated humidifier has a removable water chamber for filling with water and ease of cleaning. | Some units were manufactured with a defective humidifier chamber o-ring. Unit could leak; allowing water to escape during use; causing damage to furniture. |
Aug-10-2011 | Varian Medical Systems; Inc. Oncology Systems | Clinac; Trilogy. Trilogy Tx and Novalis Tx Linear Accelerators – Clinac; Trilogy. Trilogy Tx and Novalis Tx Linear Accelerators.Varian Medical Systems; Inc. Oncology SystemsIntended for stereotactic radiosurgery and precision radiotherapy for lesions; tumors and conditions in the body where radiation treatment is indicated. | On Varian Linear Accelerators where the customer may calibrate the collimator angle position readout in reverse; switching the 90 degree and 270 degree positions. |
Aug-10-2011 | Therakos; Inc. | THERAKOS UVAR XTS Procedural Kits – XT125 PHOTOPHERESIS PROCEDURAL KIT FOR USE WITH THE UVAR XTS INSTRUMENT; XT001 PHOTOPHERESIS PROCEDURAL KIT FOR USE WITH THE UVAR XTS INSTRUMENTSingle-use; disposable; closed system with sterile fluid pathways. The device collects the buffy coat (leukocyte-enriched blood) from the patient in a discontinuous flow process and intermittenly returns the remaining plasma and erythocytes to the patient. | Increased complaints were received of tubing leaks at the junction between the tubing and Fluid Logic Module plastic ports of the kits. |
Aug-10-2011 | Siemens Medical Solutions USA; Inc | MAGNETOM Aera/Skyra – MAGNETOM Aera/Skyra System – Nuclear magnetic resonance imaging | Firm discovered during product monitoring that on a few systems the gradient cable connections did not meet their specifications after installation. Locally; the cable connections overheated; making servicing necessary.The potential exists for a cable connection to become overheated; leading to the emission of smoke and possible material damage. |
Aug-10-2011 | Siemens Medical Solutions USA; Inc. | Symbia Radiation Therapy Pallet – Symbia Radiation Therapy Pallet. Siemens Medical Solutions USA; Inc.An accessory to the Symbia T Series Emission Computed Tomography System/X-Ray Computed Tomography System.This specialty pallet is used for performing SPECT and/or SPECT/CT Scans on oncology patients with the goal of fusing the SPECT and/or SPECT/CT data with CT simulation data for planning radiation therapy. The pallet attaches to the patient beds carbon fiber pallet. | There a potential patient safety issue when using the Symbia Radiation Therapy Pallet. When a patient is not iso-centered before starting a scan with the Symbia T Series Systems and a non-circular orbit is selected; it is possible that one of the detectors may come into contact with the patient. |
Aug-10-2011 | Siemens Medical Solutions USA; Inc | ARTISTE/RT Therapist v4.2 and/or Oncologist v4.2 systems – ARTISTE/RT Therapist v4.2 and/or Oncologist v4.2 systems.Manufactured by Siemens AG; Medical Solutions; Kemnath; Germany.Delivery of X-ray photon and electron radiation for the therapeutic treatment of cancer. | A potential safety rick related to transferring reference images for offset calculation between a syngo RT Therapist v 4.2 or a syngo RT Oncologist 4.2 and other versions of the COHERENCE/syn go RT Therapist or Oncologist or vice versa. An incorrect offset may be applied for patient positioning and result in dose being delivered to the wrong location. |
Aug-10-2011 | Toshiba American Medical Systems Inc | Aplio XG model SSA-790A – Aplio XG model SSA-790A Aplio XG (SSA-790A) is a premium-class diagnostic ultrasound system incorporating state-of-the-art technologies. It is provided with the highest level of image quality and operability (reflecting the XG (next Generation) in its name); and can be used with ease for research as well as for routine clinical studies. | Toshiba America Medical Systems Inc (TAMS) is initiating a field correction on the the Aplio XG model SSA-790A because it did not meet the requirement of clause 15b; IEC60601-1 which requires that the residual voltage shall not exceed 60V after 1 second from taking off the AC plug. |
Aug-11-2011 | Applied Medical Resources Corp | Surgical Clamp Inserts – Surgical Clamp Inserts; Model#G-8655; 86MM Insert Fibra/Fibra 15/BxSurgical Clamps and inserts are indicated for surgical clamping during cardiovascular; peripheral vascular; and general surgery. The clamps are available in 33; 45; 61 and 86 mm jaw lengths and the inserts are designed to snap easily into the clamp jaws. | The recall was initiated because Applied Medical has confirmed that Surgical Clamp Inserts; Model Numbers: G-8600; G-8650; G-8655; has the potential packaging nonconformance which could result in a compromise to the sterile barrier. |
Aug-11-2011 | Applied Medical Resources Corp | Surgical Clamp Inserts – Surgical Clamp Inserts; Model#G-8650; 86MM Insert Soft/Fibra 15/BxSurgical Clamps and inserts are indicated for surgical clamping during cardiovascular; peripheral vascular; and general surgery. The clamps are available in 33; 45; 61 and 86 mm jaw lengths and the inserts are designed to snap easily into the clamp jaws. | The recall was initiated because Applied Medical has confirmed that Surgical Clamp Inserts; Model Numbers: G-8600; G-8650; G-8655; has the potential packaging nonconformance which could result in a compromise to the sterile barrier. |
Aug-11-2011 | Applied Medical Resources Corp | Surgical Clamp Inserts – Surgical Clamp Inserts; Model#G-8600; 86MM Insert Soft/Traction; 15/BxSurgical Clamps and inserts are indicated for surgical clamping during cardiovascular; peripheral vascular; and general surgery. The clamps are available in 33; 45; 61 and 86 mm jaw lengths and the inserts are designed to snap easily into the clamp jaws. | The recall was initiated because Applied Medical has confirmed that Surgical Clamp Inserts; Model Numbers: G-8600; G-8650; G-8655; has the potential packaging nonconformance which could result in a compromise to the sterile barrier. |
Aug-11-2011 | Siemens Medical Solutions USA; Inc | Axiom Artis U – Siemens Axiom Artis U mobile x-ray systemProduct Usage: Mobile x-ray system | When the heat unit of the angiography system reaches or exceeds 65%; the cool down time display will appear with an acoustic signal. If users ignore the warning and continue the radiation; the tube may be autoprotected when it reaches its temperature limitation causing the X-Ray to lock until the tube cools down. Following a tube auto-protection; an error message "Door is Open" or "Err 421/240: |
Aug-11-2011 | Baxter Healthcare Corp. | Colleague CX Infusion Pump – Baxter Colleague CX Infusion Pump; Single Channel Volumetric Infusion Pumps. Baxter Healthcare Corporation; Deerfield; IL; product code 2M8161 | A review of Baxter service records indicates that the Baxter Colleague CX Infusion Pump has not met certain voltage specifications. This issue could potentially cause a delay in initiation of therapy. |
Aug-11-2011 | Varian Medical Systems; Inc. Oncology Systems | ECLIPSE TREATMENT PLANNING SYSTEM – Eclipse Treatment Planning System;Varian Medical Systems; Palo Alto; CA Product Usage: Eclipse Treatment Planning System is used to plan radiotherapy treatments for patients with malignant or benign diseases. It is used to plan external beam irradiation with photon; electron and proton beams; as well as for internal irradiation (Brachytherapy) treatments. | In affected Eclipse versions; the treatment field energy may change from the current selection to a previous selection without use intervention and without invalidating the MU or calculated dose distribution. |
Aug-11-2011 | Baxter Healthcare Corp. | Colleague CX Infusion Pump – Baxter Colleague CX Infusion Pump; Single Channel Volumetric Infusion Pump. Baxter Healthcare Corporation; Deerfield; IL. Product Code: 2M8161. Intended for use in a wide variety of patient environments for adult; pediatric and neonatal patients. Electronic infusion pumps indicated for continuous or intermittent delivery of solution through clinically acceptable routes of administration; such as intravenous (IV); intra-arterial (IA); subcutaneous; epidural or irrigation of fluid spaces applications. | The Colleague infusion pump may not have met certain Air in Line (AIL) specifications after testing by the Baxter Global Technical Service Center. This issue could potentially cause a delay in initiation of therapy. |
Aug-11-2011 | Varian Medical Systems; Inc. Oncology Systems | Titanium Fletcher-style Applicator Set – Defined Geometry – CT Compatible – Titanium Fletcher-style Applicator Set – Defined Geometry – CT Compatible with Titanium intrauterine probe with stopper length 50 mm; 30 degree angle.Varian Medical Systems; Palo Alto; CA;Manufactured by Varian Medical Systems Haan GmbH; Haan; Germany.To treat cancer of the uterus; cervix; endometrium and vagina. | Potential of weld failure of the Titanium intrauterine probe at the cervical stopper. |
Aug-11-2011 | Varian Medical Systems; Inc. Oncology Systems | Titanium Fletcher-style Applicator Set – Defined Geometry – CT Compatible – Titanium Fletcher-style Applicator Set – Defined Geometry – CT Compatible with Titanium intrauterine probe with stopper length 70 mm; 30 degree angle.Varian Medical Systems; Palo Alto; CA;Manufactured by Varian Medical Systems Haan GmbH; Haan; Germany.To treat cancer of the uterus; cervix; endometrium and vagina. | Potential of weld failure of the Titanium intrauterine probe at the cervical stopper. |
Aug-11-2011 | Varian Medical Systems; Inc. Oncology Systems | Titanium Fletcher-style Applicator Set – Defined Geometry – CT Compatible – Titanium Fletcher-style Applicator Set – Defined Geometry – CT Compatible with Titanium intrauterine probe with stopper length 30 mm; 30 degree angle.Varian Medical Systems; Palo Alto; CA;Manufactured by Varian Medical Systems Haan GmbH; Haan; Germany.To treat cancer of the uterus; cervix; endometrium and vagina. | Potential of weld failure of the Titanium intrauterine probe at the cervical stopper. |
Aug-11-2011 | Varian Medical Systems; Inc. Oncology Systems | Titanium Fletcher-style Applicator Set – Defined Geometry – CT Compatible – Titanium Fletcher-style Applicator Set – Defined Geometry – CT Compatible with Titanium intrauterine probe with stopper length 80 mm; 30 degree angle.Varian Medical Systems; Palo Alto; CA;Manufactured by Varian Medical Systems Haan GmbH; Haan; Germany.To treat cancer of the uterus; cervix; endometrium and vagina. | Potential of weld failure of the Titanium intrauterine probe at the cervical stopper. |
Aug-11-2011 | Varian Medical Systems; Inc. Oncology Systems | Titanium Fletcher-style Applicator Set – Defined Geometry – CT Compatible – Titanium Fletcher-style Applicator Set – Defined Geometry – CT Compatible with Titanium intrauterine probe with stopper length 60 mm; 30 degree angle.Varian Medical Systems; Palo Alto; CA;Manufactured by Varian Medical Systems Haan GmbH; Haan; Germany.To treat cancer of the uterus; cervix; endometrium and vagina. | Potential of weld failure of the Titanium intrauterine probe at the cervical stopper. |
Aug-11-2011 | Varian Medical Systems; Inc. Oncology Systems | Titanium Fletcher-style Applicator Set – Defined Geometry – CT Compatible – Titanium Fletcher-style Applicator Set – Defined Geometry – CT Compatible with Titanium intrauterine probe with stopper length 40 mm; 30 degree angle.Varian Medical Systems; Palo Alto; CA;Manufactured by Varian Medical Systems Haan GmbH; Haan; Germany.To treat cancer of the uterus; cervix; endometrium and vagina. | Potential of weld failure of the Titanium intrauterine probe at the cervical stopper. |
Aug-11-2011 | Siemens Medical Solutions USA; Inc | Linear Accelerator – ARTISTE Linear Accelerator with RT Therapist v4.1 system.Siemens Medical Solutions; Kemnath; Germany.Distributed by Siemens Medical Solutions; Concord; CA 94520.Product Usage: Linear Accelerators used to deliver X-ray photon and electron radiation for therapeutic treatment of cancer. | A potential safety issue was discovered when a pause for an imaging segment is inserted (where an imaging segment does not exist) with the ARTISTE and RT Therapist 4.1 system will continue to the next image. |
Aug-11-2011 | Stryker Medical Division of Stryker Corporation | Stryker EMS Stair – Pro Evacuation Chair – Stryker EMS Stair – Pro Evacuation Chair Model 6252It Is intended to aid in the transportation of passengers up and/or down a flight of stairs in an evacuation situation. | This recall was initiated as the firm ascertained the supplier may have reworked some of the red release bars used during the time frame of 22 December 2010 through 31 January 2011. The rework subjected the parts to excessive heat and as a result; the bars can bend during the action of squeezing the release bar against the black cross tube to release the track. The red release bars may bend to |
Aug-11-2011 | Teledyne Instruments – Analytical Instruments | Micro-Fuel Cell Oxygen Sensor; Class RI5 – Micro-Fuel Cell Oxygen Sensor; Class RI5Sensor Part Number: C41131-R15Teledyne Instruments – Analytical InstrumentsDisposable oxygen sensors with limited useful life. These sensors are accessories to other oxygen diagnostic devices; and are not in themselves suitable for therapeutic use. | The recall was initiated because during a test on a batch of sensors on the company shipping dock; Teledyne Instruments discovered electrolyte loss from the sealing cylinder on a few sensors. This test was done pursuant to a complaint from one customer of label discoloration caused because of the electrolyte loss. The riskof a leak form the oxygen sensor while in use is the disruption of therape |
Aug-11-2011 | Stryker Medical Division of Stryker Corporation | Stryker Evacuation Chair – Stryker Evacuation Chair Model 6254It Is intended to aid in the transportation of passengers up and/or down a flight of stairs in an evacuation situation. | Some of the red release bars used during the time frame of 22 December 2010 through 31 January 2011 were reworked. The rework subjected the parts to excessive heat and as a result; the bars can bend during the action of squeezing the release bar against the black cross tube to release the track. The red release bars may bend to the degree that they permanently engage the track locking mechanism |
Aug-12-2011 | Varian Medical Systems; Inc. Oncology Systems | GammaMed Flexible Applicator – GammaMed Flexible Applicator probe; 3.2mm diameter; braced PVDF.Varian Medical Systems; Palo Alto; CA.Mfg by Varian Medical Systems; Haan GmbH.Flexible Applicator Robes are designed for brachytherapy intracavitary treatments in areas such as vagina; vagina stump or rectum. | Certain GammaMed Flexible applicator probes may not have been heat annealed during manufacturing to prevent shrinkage after autoclave. |
Aug-12-2011 | Hologic; Inc. | Fluoroscan Mini C-arm – Fluoroscan Mini C-arm; Models: FSIII; FSIIIC and OfficemateThe Officemate; FSIII and FSIIIc are compact mobile fluoroscopic C-arm systems specifically designed for x-ray imaging of extremities. The systems are used by trained medical personnel; but at times are used for non medical applications. The functionality of the units is identical for the OfficeMate; FSIII and FSIIIc. Also the construction of the different models is identical. That includes the mounting of the flex arm to the cabinet and the flex arm to the C-arm. The difference between the models resides in the monitors: " Officemate has one small monitor " FSIII has two larger monitors " FSIIIc is an international version of the FSIII (power kit) | The Flex arm connector to C-arm can break and the C-arm that is supported by the flex arm may fall down |
Aug-12-2011 | Carefusion 211 Inc | AirLife Nebulizer Heater – AirLife Nebulizer Heater; Catalog Code 2M8021The AirLife Nebulizer Heater is part of the heated nebulizer system intended to provide warm bland aerosol therapy to respiratory patients. The system is used in conjunction with a standard oxygen flowmeter; which by providing pressurized oxygen powers the nebulizer creating ultra-fine particles in the therapeutic aerosol. The heater warms the solution before it reaches the aerosol jet in the nebulizer and heats the dilution air before it is entrained into the aerosol stream. An aluminum heat exchanger on the nebulizer cap transfers the thermal energy to a nebulizer solution bottle warming the solution prior to aerosolizing. | The recall was initiated because CareFusion’s Investigation has confirmed the Nebulizer Heater can; over time; develop a failure mode that results in an internal electrical short. The short can result in smoke and sparks being emitted from the device. In the presence of oxygen enriched environments and a fuel source; this failure represents a potentialrisk of flame. CareFusion is voluntarily rec |
Aug-12-2011 | Animas Corporation | Animas 2020 Insulin Infusion Pump – Animas 2020 Insulin Infusion Pump.Animas Corp.An insulin infusion. | Incorrect component (1nF capacitor) was used to produce 191 printed circuit boards used in six pump lots of which 380 pumps were distributed. This issue may result in the pump displaying a "Replace Battery" alarm not related to the condition of the battery. |
Aug-12-2011 | GE Healthcare; LLC | GE Healthcare; Seno Advantage 2.1 and 2.2 Workstations – GE Healthcare; Seno Advantage 2.1 and 2.2 Workstations with RIS CCOW integration; GE Healthcare 3000 North Grandview; Waukesha; WI 53188Seno Advantage is a medical image review station that allows easy selection; processing; filming and media interchange of multi-modality images from a variety of diagnosis imaging systems. When interpreted by a trained physician; mammographic images displayed on the high-resolution monitors may be used as an element for diagnosis. Furthermore filmed images from all modalities may also be used as an element for diagnosis. | GE Healthcare has become aware that patient mismatch could occur on some Seno Advantage 2.1 and 2.2 Workstations with RIS CCOW integration. This issue may impact patient safety.When Seno Advantage workstation is synchronized with RIS using CCOW (an HL7 standard protocol designed to enable disparate applications to synchronize in real-time); the following issues could occur: 1. Two different |
Aug-12-2011 | Aesculap Inc | Metha(R) Hip System Cobalt Chrome (CoCr) Metha Modular Neck Adapters used with the Metha Modular Sho – Metha(R) Hip System Cobalt Chrome (CoCr) Metha Modular Neck Adapters used with the Metha Modular Short Hip Stems.Aesculap AG.Intended to replace a hip joint | Aesculap Implant Systems received a notification from the manufacturer; Aesculap; AG of a fractured CoCr neck adapter. |
Aug-12-2011 | Imaging Sciences International; LLC | i-CAT Classic (X-Ray Tube head and Power Supply) – i-CAT Classic (X-Ray Tube head and Power Supply)X-Ray imaging device that constructs a three dimensional model from images taken during a rotational X-Ray sequence. Intended to be used whenever a dentist; oral surgeon or other physician needs 3D information of high contrast objects. | Recalling firm received a customer complaint regarding a defective X-ray tube head and power supply |
Aug-15-2011 | Varian Medical Systems; Inc. Oncology Systems | Eclipse Treatment Planning System – Eclipse Treatment Planning System; 4D Structure Merge Tool Option in Eclipse Release 8.5 -10 (Client Build 8.2.2x through 10.0.34) with 4D Planning; Model Number: H48; Reference/FSCA Identifier: CP-04931; Product is manufactured and distributed by Varian Medical Systems Inc.; Palo Alto; CA The Eclipse Treatment Planning System (Eclipse TPS) is used to plan radiotherapy treatments for patients with malignant or benign diseases. | An anomaly has been identified in the 4D Structure Merge option of certain versions of Varian’s Eclipse Treatment Planning System. The treatment field energy may change from the current selection to a previous selection without user intervention and without invalidating the MU or calculated dose distribution. |
Aug-15-2011 | Beckman Coulter Inc. | Access Immunoassay Systems Unconjugated Estriol – Access¿ Immunoassay Systems UNCONJUGATED ESTRIOL Part # 33570The Access Unconjugated Estriol assay is a paramagnetic particle; chemiluminescent immunoassay for the quantitative determination of unconjugated estriol levels in human serum using the Access Immunoassay Systems. | The recall was initiated because Beckman Coulter has confirmed customer reports that a single lot of Access Unconjugated Estriol reagent (PIN 33570) may produce suppressed patient results and an increased incidence of IND (Indeterminate) flags. These issues have been associated with reagent lot 913348. This reagent met all testing specifications prior to release. |
Aug-15-2011 | GYN Disposables Inc | IUD INSERTION KIT 935K – GYNDisposables Inc; IUD INSERTION KIT 935K; STERILE; SINGLE USE; Tenaculum 356T; Uterine Sound 906S; Scissors; Povidone-Iodine Solution; (3) Swabsticks; Paper Towel; STERILE EO; REF 935K; QTY 1; GYN Disposables;Inc. 2671 Appling Road; Memphis; TN 38133; ph 901.377.2200; fx 901.377.2207Intended for intrauterine device (IUD) insertion. | Lack of sterility assurance. |
Aug-15-2011 | Civco Medical Instruments Inc | CIVCO SBRT System; REF MTSBRT001; – CIVCO SBRT System; REF MTSBRT001; containing CIVCO Pro-Lok Platform; REF MTSBRT002. Firm name on label is CIVCO; Orange City; Iowa Product Usage: The recalled product is intended to support and aid in positioning a patient during radiologic and other medical procedures. | Systems sold before December 2009 displayed a scale of 0-40cm going from left to right; while systems after December 2009 reversed this and were displayed as 40-0cm from left to right. |
Aug-15-2011 | Civco Medical Instruments Inc | CIVCO Pro-Lok Platform; REF MTSBRT002 – CIVCO Pro-Lok Platform; REF MTSBRT002. Firm name on label is CIVCO; Orange City; Iowa Product Usage: The recalled product is intended to support and aid in positioning a patient during radiologic and other medical procedures. | Systems sold before December 2009 displayed a scale of 0-40cm going from left to right; while systems after December 2009 reversed this and were displayed as 40-0cm from left to right. |
Aug-15-2011 | Spacelabs Healthcare; Llc | Vital Signs Monitor; Model 93300 – Spacelabs Medical elance Vital Signs Monitor; Model 93300.The Spacelabs elance Vital Signs Monitor and elance Central Station is a prescription device intended for use by healthcare professionals in all areas of a healthcare facility. It is indicated for use in adult and pediatric populations. The device facilitates the monitoring of: ECG with arrhythmia detection; respiration; non-invasive blood pressures; invasive blood pressures; body temperature; functional arterial oxygen saturation; and entidal CO2. | The monitor has a 3 second delay in the waveforms and respiration alarm; the delay is not disclosed in the IFU. |
Aug-15-2011 | Civco Medical Instruments Inc | CIVCO SBRT System; REF MTSBRT001L – CIVCO SBRT System; REF MTSBRT001L; containing CIVCO Pro-Lok Platform; REF MTSBRT002. Firm name on label is CIVCO; Orange City; Iowa Product Usage: The recalled product is intended to support and aid in positioning a patient during radiologic and other medical procedures. | Systems sold before December 2009 displayed a scale of 0-40cm going from left to right; while systems after December 2009 reversed this and were displayed as 40-0cm from left to right. |
Aug-16-2011 | Becton Dickinson & Company | BD Vacutainer Push Button Blood Collection Set – BD Vacutainer Push Button Blood Collection Set; REF 367324 Rx only; 23 G x 3/4" x 12 " (0.6 x 19 mm x 305 mm);BD Vacutainer Push Button Blood Collection Set without Multiple Sample Luer Adaptor; Sterile; Rx only; 21 G x 3/4 x 12" 0.8 x 19 mm x 305 mmBlood collection system. | BD Vacutainer Push Button Blood Collection Set can potentially undergo cannula separation from the hub. |
Aug-16-2011 | Alter-G; Incorporated | G-Trainer – AlterG Anti-Gravity Treadmill;Alter G; 48349 Milmont Drive; Fremont; Ca 94538Product Usage: Rehabilitation of lower body injury & Neurological conditions. | Potential installation error on AlterG Anti-Gravity Treadmill that could cause greater than expected unweighting. |
Aug-16-2011 | Becton Dickinson & Company | BD Bactec Blood Culture Procedural Tray – BD Bactec Blood Culture Procedural Tray; Cat. Number 442805 Becton; Dickinson and Company; 7 Loveton Circle; Sparks; MD 21152Used in conjunction with the blood collection system. | BD Vacutainer Push Button Blood Collection Set can potentially undergo cannula separation from the hub. |
Aug-16-2011 | Beckman Coulter Inc. | Access¿ Immunoassay Systems Total T4 Calibrators – Access¿ Immunoassay Systems Total T4 Calibrators; Part Number: 33805;Subsequent Product Code: JISThe Access Total T4 Calibrators are intended to calibrate the Access Total T4 assay for the quantitative determination of total thyroxine (T4) levels in human serum and plasma using the Access Immunoassay Systems. | The recall was initiated because Beckman Coulter has confirmed that the stability claims for the Access Total T4 calibrators may not be met. This issue is associated with calibrator lots 917074 and 008534. |
Aug-17-2011 | Spacelabs Healthcare; Llc | Spacelabs Medical Patient Monitor – Spacelabs Medical Patient Monitor is a Physiological; Patient monitor With Arrhythmia Detection or Alarms. The Models are 91367; 91369; 91370; 91387; & 91393 are sold with with Perioperative Mode (option D); which includes Start case/End case functionality.Spacelabs Healthcare patient monitors; functioning as either bedside or central monitors; passively display data generated by Spacelabs Healthcare parameter modules; Flexports interfaces; and other SDLC based products in the form of waveform and numeric displays; trends and alarms. Key monitored parameters available on the models 91367; 91369; 91370 and 91387; when employing the Spacelabs Command Module; consist of ECG; respiration; invasive and noninvasive blood pressure; Sp02; temperature and cardiac output. Additional parameters and interfaces to other systems are also available depending on the parameter modules employed.Product Usage: When a clinician enters END CASE mode; there is the expectation the operation is over and the patient is being disconnected from the monitor. Removing the patient cables will trigger multiple alarms so clinicians will enter this END CASE mode to prevent having to listen to false alarms. Spacelabs Healthcare patient monitors are intended to alert the user to alarm conditions that are reported by Spacelabs Healthcare parameter modules and/or other physiologic monitors via Flexport interfaces. These devices determine: a) when an alarm condition is violated; b) the alarm priority (ie. high; medium or low); c) alarm limits; and d) when to initiate and terminate alarm notifications. The patient monitors are also capable of displaying alarm conditions on other monitors that are on the network through the Alarm Watch feature. Spacelabs Healthcare patient monitors may also function as a generic display or computer terminal. As a generic display or terminal; the patient monitors allow network-based applications to open Windows and display information on other networked monitors. Spacelabs Healthcare patient monitors are also designed to communicate with a variety of external devices such as displays; network devices; serial devices; user input devices; audio systems; and local/remote recorders. Spacelabs Healthcare patient monitors are intended for use under the direct supervision of a licensed healthcare practitioner; or by personnel trained in proper use of the equipment in a hospital environment. | The clinician did not realize the monitor was in END CASE mode and was expecting audible alarms. Visual alarms continue to work normally. |
Aug-18-2011 | Mckesson Information Solutions LLC | Horizon Medical – Horizon Medical Imaging versions 11.5; 11.5.1; 11.5.2; 11.6; 11.7 and 11.8.Horizon Medical Imaging is a medical image and information management application that is intended to receive; transmit; store; retrieve; display; print and process digital medical images; digital medical video; and associated medical information from various medical imaging systems. | Images for one patient may appear in the study of another patient. |
Aug-18-2011 | Interventional Spine Inc | BONE-LOK PLS Implant – Catalog # 9024-00 or LSW-S-3040 for 4.5mm BONE-LOK PLS ImplantA sterile; canulated screw that is supplied as a stand-alone product. The 4.5mm BONE-LOK PLS Implant is also supplied as a component of the Single Use PERPOS PLS System (9045-01 and 9045-02). The labeling and instructions for use for the 4.5mm BONE-LOK PLS a Implant (9024-00) are provided in Appendix C. | This recall has been initiated due to Pull Pins that may disengage from the Facet Screw during the compression step; requiring that compression be completed with a device driver rather than the compression tool.Use of this product may result in less than optimal compression leading to pseudoarthrosis; non-union or facet pain. |
Aug-18-2011 | Spacelabs Healthcare; Llc | Portable patient monitor with arrhythmia detection or alarms. – Product is the Ultraview Spacelabs Compact monitor; models 91367; 91369; and 91370; with touch screen display and wireless option.Product Usage: Spacelabs Medical PCIS patient monitors passively display data generated from Spacelabs Medical patient parameter modules; Flexport interfaces; gas analyzers; and other SDLC based products. Spacelabs Medical PCIS patient monitors may also function as a generic display or computer terminal. As a generic display or terminal; the PCIS patient monitors allow network based applications to open windows and display information on other networked monitors. PCIS patient monitors is intended to sound various alarm tones that are generated by the specific PCIS patient parameter modules. Each patient parameter module determines (a) when an alarm condition is violated; (b) the alarm priority (i.e. high; medium or low); (c) alarm limits; and (d) when to generate and terminate alarms. PCIS patient monitors are also capable of displaying alarm conditions on other monitors that are on the network through the Alarm Watch feature. Spacelabs Medical PCIS patient monitors are designed to communicate with a variety of external devices such as display devices; network devices; serial devices; user input devices; audio system; local/remote recorders and Spacelabs Medical patient parameter modules. In all applications; Spacelabs Medical PCIS patient monitors provide access to that data on the Spacelabs Medical network either via hardwired or wireless transmission.. Through this network; a patients data may be displayed at the bedside monitor; central station or a clinical information system. | Monitor may reset repeatedly which can result in a loss of patient monitoring for several minutes. Cause is a software problem. |
Aug-18-2011 | Interventional Spine Inc | PERPOS PLS; CATALOG #’s 9045-01 & 9045-02 – PERPOS PLS; CATALOG #’s 9045-01 & 9045-02A sterile; medical device kit consisting of the components listed in Table 1-1 below. The kit is used by medical professionals to stabilize the spine as an aid to fusion through immobilization of the facet joints. | This recall has been initiated due to Pull Pins that may disengage from the Facet Screw during the compression step; requiring that compression be completed with a device driver rather than the compression tool.Use of this product may result in less than optimal compression leading to pseudoarthrosis; non-union or facet pain. |
Aug-19-2011 | Vital Signs Devices; a GE Healthcare Company | enFlow IV Fluid Warmer – enFlow IV Fluid Warmer Part number 980105VS;(510K name: enFlow IV Fluid Warmer Model 100; EFlow Disposable Cartridge; Model 200 and EFlow AC Power Supply Model 120)Intended for warming blood; blood products; and intravenous solutions; prior to administration. Intended to be used by healthcare professionals in hospital; clinical and field environments to help prevent hypothermia. | enFlow IV Fluid Warmer may have an issue which results in excessive external surface temperature on the underside of the warmer. |
Aug-19-2011 | Steris Corporation | Amsco¿ V-PRO 1 and Amsco¿ V-PRO 1 Plus Low Temperature Sterilization Systems – Amsco¿ V-PRO 1 and Amsco¿ V-PRO 1 Plus Low Temperature Sterilization Systems Model #MLR; Serial # 033250701 – 031581115. The STERIS Amsco¿ V-PRO and V-PRO 1 Plus Low Temperature Sterilizer are self-contained stand alone devices; using vaporized hydrogen peroxide as the sterilant. The sterilizer is intended for use in the terminal sterilization of cleaned; rinsed; and dried; reusable metal and nonmetal medical devices used in healthcare facilities. The sterilization cycle operates at low pressure and temperatures; and is therefore suitable for processing medical devices sensitive to heat and moisture. | STERIS learned that Amsco? V-PRO 1 and V-PRO 1 Plus Low Temperature Sterilization Systems users may experience premature wear of the vacuum pump and filtering assembly components. Users may also experience incomplete aeration of the device’s chamber following a failed leak test. |
Aug-19-2011 | Medtronic Sofamor Danek USA Inc | TSRH(R) Spinal System SCREW – TSRH(R) Spinal System SCREW; REF 837-645; Size: 6.5mm x 45mm; Mat’l: TITANIUM ALLOY; Rx only; QTY: 1 EA; Medtronic Sofamor Danek USA. Product Usage: TSRH(R) Spinal System is intended to help provide immobilization of spinal segments as an adjunct to fusion of the thoracic; lumber; and/or sacral spine. | Screws are 5 mm longer than the size etched on the screw. |
Aug-19-2011 | Siemens Healthcare Diagnostics; Inc. | Dimension Calcium Flex Reagent – Dimension Calcium Flex Reagent is used on the Dimension clinical chemistry system as an in vitro diagnostic test intended for the quantitive determination of calcium activity in human serum; plasma and urine.Dimension(R) CA Flex(R) reagent is used on the Dimension(R) clinical chemistry system as an in vitro diagnostic test intended for the quantitative determination of calcium activity in human serum; plasma and urine. | Siemens Healthcare Diagnostic has confirmed a high frequency of "Abnormal assay" flags and imprecision. Test results across the assay range may be falsely depressed or elevated; as much as; 1.93 mg/dL at a concentration of 9.26 mg/dL. |
Aug-22-2011 | Varian Medical Systems; Inc. Oncology Systems | High-Definition 120 Multileaf Collimator (HD120 MLC) – High-Definition 120 Multileaf CollimatorHD 120 MLC is an accessory x-ray collimator designed to be mounted on Varian Trilogy Tx and Trilogy linear accelerators and is intended to shape s-ray field perimeter. Field shape can be either static (fixed) or dynamic. The intended use is to assist clinician in the delivery of radiation to defined target volumes while sparing surrounding normal tissue and critical organs from excess radiation. | When using the HD120 Multi Leaf Collimator for beam shaping; and under specific treatment conditions; dose may be delivered outside of the intended treatment field that exceeds the expected transmission dose. |
Aug-22-2011 | Boston Scientific Corporation | Resolution II Clip – The Resolution II Clip; 155 cm size and 235 cm size; Boxes of 1; 10; and 20 clips consists of a pre-loaded; radiopaque single use clip on a flexible delivery system.Endoscopic Clipping Device; Hemorrhoidal Ligator. The device is used for clip placement within the GI tract for hemostatis ( mucosal defects; bleeding ulcer; arteries; polyps); endoscopic marking; and anchoring to affix jejunal feeding tubes to the wall of the small bowel; as a supplementary method for closure of GI tract luminal perforation <20 mm that can be treated conservatively. | Boston Scientific has received reports where; following clip deployment; the alignment of the clip and delivery system does not allow for the withdrawal of the delivery system away from the clip; resulting in tissue trauma; increased bleeding and the clip being pulled off tissue as the delivery system is withdrawn. |
Aug-22-2011 | Maquet Inc. | Maquet HL Console for Heart Lung Machine HL20 – Maquet HL Console for Heart Lung Machine HL20:HL 20 4-pumps console base: P/N 917741HL 20 5-pumps console base: P/N 917751The HL 20 is indicated for use as an extracorporeal circulation device for perfusion lasting not more then six hours. The HL console is equipped with a rack for accommodating the system’s electronic modules. | HL 20 Consoles for 4-pump and 5-pump configuration can malfunction if an excessive amount of liquid is used causing circuit board malfunction. |
Aug-22-2011 | Draeger Medical Systems; Inc. | Gamma X XL Portable Patient Monitor – Infinity Gamma X XL Portable Patient Monitor. Draeger Medical Systems; Inc.Portable monitor used to monitor vital signs of neonatal; pediatric; and adult patients for bedside and transport applications. | Monitor keys may spontaneously become inoperative or active. This may cause a membrane switch panel malfunction; which could result in the monitor discharging a patient automatically. |
Aug-22-2011 | Draeger Medical Systems; Inc. | Infinity Delta Portable Patient Monitor – Infinity Delta Portable Patient Monitor. Draeger Medical Systems; Inc.Portable monitor used to monitor vital signs of neonatal; pediatric; and adult patients for bedside and transport applications. | Monitor keys may spontaneously become inoperative or active. This may cause a membrane switch panel malfunction; which could result in the monitor discharging a patient automatically. |
Aug-22-2011 | Varian Medical Systems; Inc. Oncology Systems | Flexible Probe with Blocking Washer – Flexible Probe with Blocking Washer (part of Segmented Cylinder Set)The Segmented Cylinder Applicator Set was developed to treat cancer of the vagina; vaginal stump and rectum. | Blocking washers on the Flexible Probe with Blocking washers may shift and cause potential for treatment length error. |
Aug-22-2011 | Steris Corporation | Verify¿ SixCess Challenge Pack – Verify¿ SixCess Challenge Pack; Model #’s: LCC003; LCC005; LCC014 & LCC310; Mfr. By: Albert Browne; LTD; Chancery House 190 Waterside Rd. Hamilton Industrial Park; Leicester; Leicester; LE5QZ; United Kingdom.Verify¿ SixCess Challenge Packs are used to confirm that that critical parameters of steam sterilization have been reached within a challenging test pack design. Each challenge pack is also specific to a sterilization temperature and type (i.e. 275¿F 3 minute Prevacuum Cycle). | During an inspection the firm was notified that language contained in labeling and promotional literature directs Customers that the products can be used to replace biological indicators and/or release loads containing implants. |
Aug-22-2011 | Churchill Medical Systems; Inc. | Churchill Medical – Churchill Medical Latex-Free IV Start KitProduct Code: AMS-623ATLFThe kit includes a tourniquet; alcohol prep pads; a PVP ampule swab; 1 3M" Transpore tape roll; 2 gauze sponges; a 3M" Tegaderm" dressing; and a dressing change labelAMS-623ATLF is a convenient kit that aids in preparing the insertion site for the start of intravenous therapy | Outer Kit labeled expiration date longer than the expiration of the shortest expired product |
Aug-22-2011 | Steris Corporation | Verify¿ SixCess Indicator Strips – Verify¿ SixCess Indicator Strips; Model #: PCC005; PCC006; PCC007; PCC008; PCC031; PCC033; PCC034; PCC037 & PCC038; Mfr. By: Albert Browne; LTD; Chancery House 190 Waterside Rd. Hamilton Industrial Park; Leicester; Leicester; LE5QZ; United Kingdom.Verify¿ SixCess Indicator Strips are used to confirm that the parameters of sterilization have been reached within packs; pouches and wrapped items processed through a steam sterilization process. Each indicator strip is specific to a sterilization temperature and type (i.e. 250¿F 30 minute Gravity Cycle). | During an inspection the firm was notified that language contained in labeling and promotional literature directs Customers that the products can be used to replace biological indicators and/or release loads containing implants. |
Aug-22-2011 | Smith & Nephew; Inc. Endoscopy Division | Smith & Nephew – Smith & Nephew; Tendon Stripper; Slotted; 5.0 mm I.D. x12 working length. Non-SterileCatalog Number: 013554Orthopedic Manual Surgical Instrument | Shaft tip (casting) does not meet the SNE 416specification; which could result in rusting of the Tendon Strippers |
Aug-22-2011 | Bio-Rad Laboratories | Kallestad Mouse Stomach/Kidney (MSK) Test Kit – "BIO-RAD***Kallestad Mouse Stomach/Kidney 8 Well Slides***Bio-Rad Laboratories; Redmond; WA 98052***STORE FROZEN***"The test kit contains slides and substrate.For use as an indirect fluorescent antibody procedure for the detection and semi-quantitation of human autoantibodies. | KALLESTAD Mouse Stomach/Kidney (MSK) test kits contained Crithidia slides instead of the MSK slides. |
Aug-23-2011 | Jay Bird Investments Inc | @ Home Strep Test – @ Home Strep TestRapid Strep TestProduct Usage: For in-vitro diagnostic use – detection of Strep. | Home Strep Test does not qualify as a Class I device and needs pre-market approval. |
Aug-23-2011 | Boston Scientific Corporation | Katzen" Infusion Wire – Katzen" Infusion Wire; 0.035 in x 180 cm; UPN Product No. M001461930; RED Catalog No. 46-193; Made in USA 8600. Boston Scientific. NW 41 Street; Miami; FL 33166.Intended for the infusion of therapeutic agents (i.e.; heparin; saline; thrombolytic agents; etc) in the peripheral vasculature. The wire allows for the delivery of agents in either a "pulse -spray" or " slow weep" technique. | Boston Scientific is voluntarily recalling one lot/batch of Katzen" Infusion Wires because we have identified that the label on the carton and the inner pouch indicated an incorrect device length. The labels indicate a device length of 180cm while the actual device length is 145cm. |
Aug-23-2011 | Alliant Enterprises LLC | TruChoice and 3-T Medical Systems Adjustable Vent Valve – Non-Adjustable Vent Valve; TruChoice Alliant Healthcare Products; REFERENCE#213-035NS QUANTITY: 100; DESCRIPTION: NONADJUSTABLE VENT VALVE; NON-STERILE; AND and 3-T Medical Systems; Catalog #035NS; Non-Adjustable One Way Vent Valve; Quantity: 100; NON-STERILEThe TrueChoice and 3-T Vacuum Control One-Way Vent Valve is indicated for use during cardiopulmonary bypass surgery to help prevent the buildup of excess vacuum pressure when suctioning either from the heart or the surgical field; and to help prevent inadvertent retrograde flow and air to the heart. | The firm is initiating this recall due to the receipt of 2 complaints of malfunction of the joint holding the 2 halves of the vent valve together. |
Aug-23-2011 | Alliant Enterprises LLC | TruChoice Adjustable Vent Valve – Non-Adjustable Vent Valve; TruChoice Alliant Healthcare Products; REFERENCE#213-035 QUANTITY: 25; DESCRIPTION: NONADJUSTABLE VENT VALVE; STERILEThe TrueChoice Vacuum Control One-Way Vent Valve is indicated for use during cardiopulmonary bypass surgery to help prevent the buildup of excess vacuum pressure when suctioning either from the heart or the surgical field; and to help prevent inadvertent retrograde flow and air to the heart. | The firm is initiating this recall due to the receipt of 2 complaints of malfunction of the joint holding the 2 halves of the vent valve together. |
Aug-23-2011 | Alliant Enterprises LLC | TruChoice Adjustable Vent Valve – TruChoice Alliant Healthcare Products; REFERENCE# SSD-100EX; QUANTITY: 25; DESCRIPTION: TUBING W/ ONE WAY VALVE; STERILEThe TrueChoice Vacuum Control One-Way Vent Valve is indicated for use during cardiopulmonary bypass surgery to help prevent the buildup of excess vacuum pressure when suctioning either from the heart or the surgical field; and to help prevent inadvertent retrograde flow and air to the heart. | The firm is initiating this recall due to the receipt of 2 complaints of malfunction of the joint holding the 2 halves of the vent valve together. |
Aug-23-2011 | Alliant Enterprises LLC | TruChoice Adjustable Vent Valve – Adjustable Vent Valve; TruChoice Alliant Healthcare Products REFERENCE#213-030 QUANTITY: 25 DESCRIPTION: ADJUSTABLE VENT VALVE; STERILEThe TruChoice Vacuum Control One-Way Vent Valve is indicated for use during cardiopulmonary bypass surgery to help prevent the buildup of excess vacuum pressure when suctioning either from the heart or the surgical field; and to help prevent inadvertent retrograde flow and air to the heart. | The firm is initiating this recall due to the receipt of 2 complaints of malfunction of the joint holding the 2 halves of the vent valve together. |
Aug-23-2011 | Sysmex America; Inc. | Sysmex Stromatolyser-IM (SIM-220A) – Sysmex Stromatolyser-IM; a lytic reagent for use with the XE-2100; XE-2100L and XE-5000 Series Sysmex Automated Hematology Analyzers; the reagent solution is supplied in a 10-liter cubetainer (cardboard cube with a 10-liter plastic liner); Sysmex America; Inc.; Mundelein; IL 60060; catalog number SIM-220A. The STROMATOLYSER-IM lysing reagent is used to destroy red blood cells to aid in the counting and characterization on immature white blood cells. This reagent is used on the Sysmex XE-Series and SE Series hematology analyzers. | The affected lots of Stromatolyser-IM lysing reagent were found to be contaminated with Pseudomonas bacteria; which resulted in rising IMI channel background counts; increased false "Platelet Clump" flags and a strong sulfur-like odor when used on the XE-2100; XE-2100L and XE-5000 analyzers. |
Aug-23-2011 | Alliant Enterprises LLC | TruChoice and 3-T Medical Systems Adjustable Vent Valve – Adjustable Vent Valve; TruChoice Alliant Healthcare Products REFERENCE#213-030NS QUANTITY: 100 DESCRIPTION: ADJUSTABLE VENT VALVE; NON-STERILE; and 3T Medical Systems Catalog# 030NS Adjustable One Way Vent Valve; Quantity: 100; NON-STERILEThe TruChoice and 3-T Vacuum Control One-Way Vent Valve is indicated for use during cardiopulmonary bypass surgery to help prevent the buildup of excess vacuum pressure when suctioning either from the heart or the surgical field; and to help prevent inadvertent retrograde flow and air to the heart. | The firm is initiating this recall due to the receipt of 2 complaints of malfunction of the joint holding the 2 halves of the vent valve together. |
Aug-24-2011 | Applied Medical Resources Corp | Applied Medical Kii Optical Access System – Applied Medical 15×100 mm Kii Optical Access Systems; Non-Threaded 6/Box; Model C0R36Product Usage: Applied Medical’s C0R36; C0R37; C0R38; and C0R39 trocars are diposable single-use devices indicated for use in general; abdominal; gynecological and thoraic minimally invasive surgeries. Trocars establish a path of entry through tissue planes and into internal spaces for purposes of inserting endoscopic instruments that are used to perform surgery on internal organs. | The recall was expanded on December 22; 2009 to include four models: C0R36; C0R37; C0R38; and C0R39. Initially; Applied Medical conducted a voluntary recall on June 9; 2009 of two lot numbers; 1084426 and 1085506; of the 15 mm Kii non-threaded optical access system; model C0R36; due to a potential weakness in the cannula tip; possibly resulting in a tip breakage. |
Aug-24-2011 | Applied Medical Resources Corp | Applied Medical Kii Optical Access System – Applied Medical 15×100 mm Kii Optical Access Systems; Non-Threaded 6/Box; Model C0R37Product Usage: Applied Medical’s C0R36; C0R37; C0R38; and C0R39 trocars are diposable single-use devices indicated for use in general; abdominal; gynecological and thoraic minimally invasive surgeries. Trocars establish a path of entry through tissue planes and into internal spaces for purposes of inserting endoscopic instruments that are used to perform surgery on internal organs. | The recall was expanded on December 22; 2009 to include four models: C0R36; C0R37; C0R38; and C0R39. Initially; Applied Medical conducted a voluntary recall on June 9; 2009 of two lot numbers; 1084426 and 1085506; of the 15 mm Kii non-threaded optical access system; model C0R36; due to a potential weakness in the cannula tip; possibly resulting in a tip breakage. |
Aug-24-2011 | Applied Medical Resources Corp | Applied Medical Kii Optical Access System – Applied Medical 15×100 mm Kii Optical Access Systems; Non-Threaded 6/Box; Model C0R38Product Usage: Applied Medical’s C0R36; C0R37; C0R38; and C0R39 trocars are diposable single-use devices indicated for use in general; abdominal; gynecological and thoraic minimally invasive surgeries. Trocars establish a path of entry through tissue planes and into internal spaces for purposes of inserting endoscopic instruments that are used to perform surgery on internal organs. | The recall was expanded on December 22; 2009 to include four models: C0R36; C0R37; C0R38; and C0R39. Initially; Applied Medical conducted a voluntary recall on June 9; 2009 of two lot numbers; 1084426 and 1085506; of the 15 mm Kii non-threaded optical access system; model C0R36; due to a potential weakness in the cannula tip; possibly resulting in a tip breakage. |
Aug-24-2011 | Applied Medical Resources Corp | Applied Medical Kii Optical Access System – Applied Medical 15×100 mm Kii Optical Access Systems; Non-Threaded 6/Box; Model C0R39Product Usage: Applied Medical’s C0R36; C0R37; C0R38; and C0R39 trocars are diposable single-use devices indicated for use in general; abdominal; gynecological and thoraic minimally invasive surgeries. Trocars establish a path of entry through tissue planes and into internal spaces for purposes of inserting endoscopic instruments that are used to perform surgery on internal organs. | The recall was expanded on December 22; 2009 to include four models: C0R36; C0R37; C0R38; and C0R39. Initially; Applied Medical conducted a voluntary recall on June 9; 2009 of two lot numbers; 1084426 and 1085506; of the 15 mm Kii non-threaded optical access system; model C0R36; due to a potential weakness in the cannula tip; possibly resulting in a tip breakage. |
Aug-24-2011 | Angiodynamics; INC | Habib; 4x Kit 4401L – Habib; 4x Kit; Bipolar Resection Device RITA (Radiofrequency Ablation Devices).AngioDynamics; Inc.; One Horizon Way; Manchester; GA 30816.Intended to be used to assist in coagulation of tissue during intraoperative surgical procedures. | The labeling contains errors which result in the products being misbranded |
Aug-24-2011 | Angiodynamics; INC | Vortex MP-P5SAT Port – Vortex MP Port Single Titanium Port with Attached (5Fr) Silicone Catheter; AngioDynamics; Inc.; One Horizon Way; Manchester; GA 30816Indicated for central venous placement (either peripheral or chest placement) when patient therapy requires repeated venous access for injection or infusion therapy and/or venous blood sampling. | The labeling contains errors which result in the products being misbranded |
Aug-24-2011 | Angiodynamics; INC | Vortex MP-P5SDT Port – Vortex MP Port Single Titanium Port with Attachable (5Fr) Silicone Catheter; AngioDynamics; Inc.; One Horizon Way; Manchester; GA 30816Indicated for central venous placement (either peripheral or chest placement) when patient therapy requires repeated venous access for injection or infusion therapy and/or venous blood sampling. | The labeling contains errors which result in the products being misbranded |
Aug-24-2011 | Angiodynamics; INC | Habib; 4x Kit 4401 – Habib; 4x Kit; Bipolar Resection Device RITA (Radiofrequency Ablation Devices). AngioDynamics; Inc.;One Horizon Way; Manchester; GA 30816.Intended to be used to assist in coagulation of tissue during intraoperative surgical procedures. | The labeling contains errors which result in the products being misbranded |
Aug-24-2011 | Arjo; Inc. dba ArjoHuntleigh | Entroy Pool Lift – Entroy Pool Lift; a patient lift used in conjunction with a chair or stretcher to lift them in/out of a swimming/therapy pool; Arjo Hospital Equipment AB; Eslov; Sweden; Models GAB1000-01-xx; GAB1000-11-xx and GAC100xEntroy is a pool lift that docks to either a chair or a stretcher and aids disabled people getting in and out of a pool. This equipment is intended for disabled persons who need to transfer in and out of a therapy and swimming pool under supervision of skilled and trained personnel in accordance with the Entroy Operating and Product Care Instructions. All other use must be avoided. Active/semi-active persons can and should use the Entroy chair (with or without chassis) while bedridden persons without trunk stability can and should be transferred with the Entroy stretcher with chassis. | The Entroy Pool Lift boom may rapidly lower un-commanded to the bottom of its stroke; with a potential for injury to the resident or caregiver. |
Aug-25-2011 | GE Healthcare; LLC | GE Healthcare; DASH 3000; 4000; 5000 Patient Monitors – GE Healthcare; DASH 3000; 4000; 5000 Patient MonitorsThe Dash 3000/4000/5000 patient monitor is intended for use under the direct supervision of a licensed healthcare practitioner. The intended use of the system is to monitor physiologic parameter data on adult; pediatric and neonatal patients. The Dash 3000/4000/5000 patient monitor is designed as a bedside; portable; and intra-hospital transport monitor that can operate in all professional medical facilities including but not limited to: emergency department; operating room; post anesthesia recovery; critical care; surgical intensive care; respiratory intensive care; coronary care; medical intensive care; pediatric intensive care; or neonatal intensive care areas located in hospitals; outpatient clinics; free-standing surgical centers; and other alternate care facilities. Physiologic data includes but is not restricted to: electrocardiogram; invasive blood pressure; noninvasive blood pressure; heart rate; temperature; cardiac output; respiration; pulse oximetry; carbon dioxide; bi-spectral index; impedance cardiography; oxygen; and anesthetic agents as summarized in the operator’s manual. The Dash 3000/4000/5000 patient monitor is also intended to provide physiologic data over the UNITY NETWORK TM indirectly to clinical information systems (via our Enterprise Gateway) and allow the user to access hospital data at the point-of-care. The information can be displayed; trended; stored; and printed. The Dash 3000/4000/5000 patient monitor was developed to interface with nonproprietary third party peripheral devices that support serial data outputs. | GE Healthcare has recently become aware of an issue with the Dash 3000/4000/5000 patient monitors configured with the 802.11b wireless LAN option that may impact patient safety. The Dash monitor may exhibit reboots on some networks when the 802.11b wireless LAN option is used to connect to the hospital wireless LAN infrastructure. This reboot results in a loss of patient monitoring for approxima |
Aug-29-2011 | Impact Instrumentation; Inc. | Model 754/754M Disposable MRI Ventilator Circuit – Model 754/754M Disposable MRI Ventilator Circuit Impact Instrumentation Inc.; 23 Fairfield Place; West Caldwell; NJ 07006.Accessory for 700 Series 754/754m Ventilators during MRI examinations | Model 754/754 M Disposable MRI Ventilator Circuits are being distributed without market clearence (510k). |
Aug-29-2011 | Fresenius Medical Care Holdings; Inc. | Fresenius – Fresenius 2008K@homeThe Fresenius 2008K@home is indicated for acute and chronic dialysis therapy in an acute or chronic facility. The 2008K@home is also indicated for hemodialysis in the home and must be observed by a trained and qualified person as prescribed by their physician. | Upgrade software to implement new on screen graphics and instructions; the addition of a bracket on the side of the machine to temporarily hold the bloodlines during set up in order to conform to approved 510(k) |
Aug-29-2011 | Orthohelix Surgical Designs Inc | Mini MaxLock Extreme Plating System Case and Tray – Mini MaxLock Extreme Plating System Case & Tray; Model Number(s): MXM-901; Product Usage: The Mini MaxLock Extreme Plating System is intended to stabilize and aid in the repair of fractures; fusions; and osteotomies for small bones and bone fragments. Surgical Case and Tray Delivery System used to house plating and screw orthopedic implant system and instrumentation. | The surgical tray does not meet our Instruction for Use (IFU) for dry time requirement. |
Aug-29-2011 | Maquet Inc. | Maquet HL Console for Heart Lung Machine HL20 – Maquet HL Console for Heart Lung Machine HL20HL 20 4-umps console base: P/N 917741HL 20 5-pumps console base: P/N 917751Intended for use as an extracorporeal circulation device for perfusion lasting not more than six hours. The HL console is equipped with a rack for accommodating the system’s electronic modules. | Maquet HL 20 Twin Pump Modules may unintentionally increase speeds for a 1.5-2 second period of time before returning to its original speed. |
Aug-29-2011 | Roche Diagnostics Operations; Inc. | MagNA Pure LightCycler – MagNA Pure LC 1.0 (software version 3.0.11).Roche Diagnostics Operations; Inc.An automated instrument used for isolation of nucleic acids (DNA; total RNA; total viral nucleic acids) from different kinds of biological research sample material (whole blood; serum; blood cells; culture cells; tissue; bacteria; fungi) using the specially designed MagNA Pure LC kits; for the purpose of life science research only and automated filling of different kinds of PCR reaction vessels (LightCycler Capillaries; 96-well PCR plates; PCR tube strips) with PCR reaction mixes and template nucleic acid; or other reaction tubes for the making of dilution series; reaction mixes. | Roche has detected a problem with the MagNA Pure LC 1.0 (software version 3.0.11) and the MagNA Pure LC 2.0 (software versions 1.1.23 and 1.1.24) instruments. Under certain circumstances; only a fraction of each sample is processed which may lead to false negative results; and an impact to patient health if used in a homebrew diagnostic application. |
Aug-29-2011 | Roche Diagnostics Operations; Inc. | MagNA Pure LightCycler – MagNA Pure LC 2.0 (software version 1.1.23 and 1.1.24)Roche Diagnostics Operations; Inc.An automated instrument used for isolation of nucleic acids (DNA; total RNA; total viral nucleic acids) from different kinds of biological research sample material (whole blood; serum; blood cells; culture cells; tissue; bacteria; fungi) using the specially designed MagNA Pure LC kits; for the purpose of life science research only and automated filling of different kinds of PCR reaction vessels (LightCycler Capillaries; 96-well PCR plates; PCR tube strips) with PCR reaction mixes and template nucleic acid; or other reaction tubes for the making of dilution series; reaction mixes. | Roche has detected a problem with the MagNA Pure LC 1.0 (software version 3.0.11) and the MagNA Pure LC 2.0 (software versions 1.1.23 and 1.1.24) instruments. Under certain circumstances; only a fraction of each sample is processed which may lead to false negative results; and an impact to patient health if used in a homebrew diagnostic application. |
Aug-29-2011 | Tornier; Inc | Tornier Latitude Elbow Prosthesis – Latitude"; Tige Humerale; Humeral Stem; Medium 77 mm; Humeral Stem Right; For Cemented use only; Sterile R; REF 0030402; Tornier In. Edina; MN 55435 USA.The Tornier In. Latitude Elbow Prosthesis is intended for total elbow arthroplasty. Prosthetic replacement with this device may be indicated to relieve severe pain or significant disability following the effects of primary or secondary osteoarthritis and rheumatoid arthritis; correction of functional deformities; revision procedures where other treatments or devices have failed; treatment of fractures that are unmanageable using others techniques. The Tornier In. Latitude Elbow Prosthesis is intended for cemented use only. | Tornier has discovered that some models of the Tornier latitude Elbow Prosthesis (Small and Medium Humeral stems) were manufactured with a humeral screw that may not function as designed. |
Aug-29-2011 | Microline Surgical; Inc. | Microline Surgical ReNew Laproscopic Long Fenestrated Grasper Forceps Tip – Microline Surgical ReNew Laproscopic Long Fenestrated Grasper Forceps TipRef: 3262The ReNew Forceps Laparoscopic Surgical Tips are intended to cut; grasp and dissect various abdominal tissue for use in endoscopic; including laparoscopic surgical procedures where instruments are introduced into the body through a cannula | Mislabeled: ReNew product number 3262 (Long Fenestrated Grasper) was packaged and labeled asproduct number 3642 (Super-Atrau Fenestrated Grasper). ReNew product number 3642 (Super-Atraumatic Fenestrated Grasper) was packaged andlabeled as 3262 (Long Fenestrated Grasper |
Aug-29-2011 | Microline Surgical; Inc. | Microline Surgical ReNew Laproscopic ControlTip Atraumatic Fenestrated Grasper Forceps Tip – Microline Surgical ReNew Laproscopic ControlTip Atraumatic Fenestrated Grasper Forceps TipRef: 3642The ReNew Forceps Laparoscopic Surgical Tips are intended to cut; grasp and dissect various abdominal tissue for use in endoscopic; including laparoscopic surgical procedures where instruments are introduced into the body through a cannula | Mislabeled: ReNew product number 3262 (Long Fenestrated Grasper) was packaged and labeled asproduct number 3642 (Super-Atrau Fenestrated Grasper). ReNew product number 3642 (Super-Atraumatic Fenestrated Grasper) was packaged andlabeled as 3262 (Long Fenestrated Grasper |
Aug-29-2011 | Elekta; Inc. | The Elekta Synergy System – Elekta SynergyThe Elekta Synergy System is intended to be used for radiation therapy treatment of malignant neoplastic diseases; as determined by a licensed medical practitioner. | A small number of the Modular Reverse Diodes (D1A); a component in the equipment room of the Elekta Linear Accelerator; have ruptured. |
Aug-29-2011 | American Stress Technologies; Inc. | Prism Laser 7642 – Prism Laser 7642Laser System | It was discovered The Prism 7642 was not certified at the time of delivery. The product lacks the required labeling and the product was sold and delivered without the submission of the Initial Product Report. The product lacks User In formation |
Aug-30-2011 | Bausch & Lomb Inc | Bausch & Lomb Stellaris 1.8mm Premium Vacuum Phaco Pack with MICS Needle; Ref: BL5114 – Bausch & Lomb Stellaris 1.8mm Premium Vacuum Phaco Pack with MICS Needle; Ref: BL5114; packaged 6 units/case; RX; Sterile. Bausch & Lomb Incorporated; Rochester; NYFor use with the Bausch & Lomb Stellaris Vision Enhancement System for the phacoemulsification of an opacified crystalline lens during anterior segment surgery | The aspiration channel on the affected vacuum cassettes may be blocked due to a molding malfunction |
Aug-30-2011 | Bausch & Lomb Inc | Bausch & Lomb Stellaris Optimized Stability Vacuum Pack; Ref: BL5112 – Bausch & Lomb Stellaris Optimized Stability Vacuum Pack; Ref: BL5112; packaged 6 units/case; RX; Sterile. Bausch & Lomb Incorporated; Rochester; NYFor use with the Bausch & Lomb Stellaris Vision Enhancement System for the phacoemulsification of an opacified crystalline lens during anterior segment surgery | The aspiration channel on the affected vacuum cassettes may be blocked due to a molding malfunction |
Aug-30-2011 | Bausch & Lomb Inc | Bausch & Lomb Stellaris Basic Vacuum Phaco Pack; Ref: BL5111 – Bausch & Lomb Stellaris Basic Vacuum Phaco Pack; Ref: BL5111; packaged 6 units/case; RX; Sterile. Bausch & Lomb Incorporated; Rochester; NYFor use with the Bausch & Lomb Stellaris Vision Enhancement System for the phacoemulsification of an opacified crystalline lens during anterior segment surgery | The aspiration channel on the affected vacuum cassettes may be blocked due to a molding malfunction |
Aug-30-2011 | Bausch & Lomb Inc | Bausch & Lomb Stellaris Premium Vacuum Phaco Pack; Ref: BL5110 – Bausch & Lomb Stellaris Premium Vacuum Phaco Pack; Ref: BL5110; packaged 6 units/case; RX; Sterile. Bausch & Lomb Incorporated; Rochester; NYFor use with the Bausch & Lomb Stellaris Vision Enhancement System for the phacoemulsification of an opacified crystalline lens during anterior segment surgery. | The aspiration channel on the affected vacuum cassettes may be blocked due to a molding malfunction |
Aug-30-2011 | DePuy Orthopaedics; Inc. | PFC Sigma Round Dome Patella – PFC Sigma Round Dome Patella 38 MM 3 PegDevice is indicated for use in knee replacement procedures in conjunction with femoral knee prosthesis components and polymethylmethacrylate (PMMA) bone cement. | DePuy initiated a voluntary recall effective immediately; for one lot of P.F.C. SIGMA RD Dome Patella 3 Peg (38mm) due to packaging labels that did not correctly reflect the size of the enclosed patellar component. In the recalled lot; the packaging is labeled for a P.F.C. SIGMA 38mm 3 peg Round Dome Patella; but the product enclosed in the package is a P.F.C. SIGMA 35mm 3 peg Oval Dome Patella. |
Aug-30-2011 | Encision; Inc. | Encision AEM Suction Irrigation Electrode; J-Hook – Encision AEM Suction Irrigation Electrode; J-Hook; REF ES3884.Encision Inc.; Boulder; CO 80301.The Suction Irrigation Electrodes and Adapters combine AEM shielding technology with suction and irrigation of fluids during laparoscopic electrosurgery to cut and coagulate tissue. The electrodes connect to a compatible electrosurgical generator via an adapter on the Encision AEM Monitor. | Electrode tips have been reported breaking off during use or cleaning. |
Aug-30-2011 | Encision; Inc. | Encision AEM Suction Irrigation Electrode; Needle Tip; – Encision AEM Suction Irrigation Electrode; Needle Tip; REF ES3885; Encision Inc.; Boulder; CO 80301. | Electrode tips have been reported breaking off during use or cleaning. |
Aug-30-2011 | Encision; Inc. | Encision AEM Suction Irrigation Electrode; L-Hook; – Encision AEM Suction Irrigation Electrode; L-Hook; REF ES3883; Encision Inc.; Boulder; CO 80301.The Suction Irrigation Electrodes and Adapters combine AEM shielding technology with suction and irrigation of fluids during laparoscopic electrosurgery to cut and coagulate tissue. The electrodes connect to a compatible electrosurgical generator via an adapter on the Encision AEM Monitor. | Electrode tips have been reported breaking off during use or cleaning. |
Aug-30-2011 | Encision; Inc. | Encision AEM Suction Irrigation Electrode; Spatula – Encision AEM Suction Irrigation Electrode; Spatula; REF ES3882; Encision Inc.; Boulder; CO 80301.The Suction Irrigation Electrodes and Adapters combine AEM shielding technology with suction and irrigation of fluids during laparoscopic electrosurgery to cut and coagulate tissue. The electrodes connect to a compatible electrosurgical generator via an adapter on the Encision AEM Monitor. | Electrode tips have been reported breaking off during use or cleaning. |
Aug-30-2011 | Encision; Inc. | Encision AEM Suction Irrigation Electrode; L-Diamond – Encision AEM Suction Irrigation Electrode; L-Diamond; REF ES3881.Encision Inc.; Boulder; CO 80301.The Suction Irrigation Electrodes and Adapters combine AEM shielding technology with suction and irrigation of fluids during laparoscopic electrosurgery to cut and coagulate tissue. The electrodes connect to a compatible electrosurgical generator via an adapter on the Encision AEM Monitor. | Electrode tips have been reported breaking off during use or cleaning. |
Aug-30-2011 | Varian Medical Systems; Inc. Oncology Systems | 4D Integrated Treatment Console (4DITC) – Varian brand 4D Integrated Treatment Console (4DITC) Radiation Therapy; Interpretation of a RapidArc Treatment Plan as a 3D Conformal Arc Treatment Plan; version v8.6 or 8.8 in combination with treatment planning systems; Model Number: H51; Reference/PSCA Identifier: CP-03063; Product is manufactured and distributed by Varian Medical Systems Inc.; Palo Alto; CAProduct Usage: 4D Integrated treatment console is designed to assist the operator of a radiation device in providing accurate treatment set-ups for each patient by monitoring set up parameters and preventing the radiation therapy device from commencing irradiation while any parameter is out of conformance with the treatment plan. | The firm has identified that in certain configurations; the 4DITC can interpret a RapidArc or VMAT treatment field as 3D Conformal Arc Treatment Plan. If a RapidArc or VMAT treatment field is incorrectly interpreted as Conformal Arc; the field will be delivered with a constant dose rate and gantry speed for the entire duration of the delivery; which can lead to delivered dose being different than |
Aug-30-2011 | Covidien; PLC | Evident MWA Generator – Evident MWA Generator; REF VTGEN; Output: 60 W / 50 Ohm; Valleylab; a division of Tyco Healthcare Group LP Boulder; CO 80301.Intended for the coagulation of soft tissue. Not intended for use in cardiac procedures. | Generator may deliver full power when a lower power is selected. |
Aug-30-2011 | Advanced Neuromodulation Systems | Rapid Programmer – Software version 3.3 for Rapid Programmer devices; Model 3832.Software version 3.3 for Rapid Programmer devices; a personal digital assistant (PDA) based programmer supporting implantable pulse generators of the Eon; Genesis; and Renew family. | Product programmed with unapproved software was distributed. |