Class I recalls
Recalling Manufacturer, Date Posted, Trade Name/Product, Reason for Recall
Smiths Medical ASD; Inc. Aug-01-2012 Medfusion¿ 4000 V1.0 &V1.1 Syringe Infusion Pump – Smiths Medical; Medfusion¿ Syringe Infusion Pump; Model 4000; Software Version V1.0 & V1.1; Reorder Numbers 4000-0100-50; 4000-0100-95; 4000-0101-50; 4000-0101-51; and 4000-0101-78.Designed for use in care areas for the administration of fluids requiring precisely controlled infusion rates. Smiths Medical has identified a software anomaly in the Medfusion 4000 Syringe Infusion Pump that causes a device history log corruption and triggers a Watchdog Fail-Safe alarm. When the device exhibits this failure mode; visual and audible alarms will sound and the device ceases operation.
GE OEC Medical Systems; Inc Aug-08-2012 FluoroTrak Spinal Navigation System – Radiological Image Processing SystemThe system is an aid to locate anatomical structures during open or percutaneous surgical procedures. It is indicated for use in medical conditions that may benefit from the use of stereotactic surgical technique. The system provides a reference to rigid anatomical structures such as sinus; skull; long bone; or vertebra; which are visible on medical images such as CS; MR; or X-ray. The FluoroTrak Spinal Navigation Application on the OEC 9900 EliteNAV could result in an incorrect position of the navigated instrument(s) versus the displayed reference image.
Baxter Healthcare Corp. Aug-08-2012 AUTOMIX 3 + 3/AS – AUTOMIX 3+3 Compounder with Accusource Monitoring System; product 2M8287; automated nutrition compounders; Product Usage: The Automix Compounder Systems are electromechanical positive displacement fluid compounding devices used in the admixture of large volume parenteral nutrition formulations via gravimetric weighing. After fluid ingress into the keypad of the AUTOMIX Compounder’s (AUTOMIX) control module; the AUTOMIX may generate an incorrect device response to an AUTOMIX operator’s key press. Also; the AUTOMIX system may experience an intermittent electrical failure; in which unexpected pump motor operations will occur. Also; the AUTOMIX system may intermittently experience an electrical failure where thec
Baxter Healthcare Corp. Aug-08-2012 AUTOMIX 3 + 3 – AUTOMIX 3+3 Compounder System; product 2M8286 (115V) and 2M8286K (230V); automated nutrition compounders; Product Usage: The Automix Compounder Systems are electromechanical positive displacement fluid compounding devices used in the admixture of large volume parenteral nutrition formulations via gravimetric weighing. After fluid ingress into the keypad of the AUTOMIX Compounder’s (AUTOMIX) control module; the AUTOMIX may generate an incorrect device response to an AUTOMIX operator’s key press. Also; the AUTOMIX system may experience an intermittent electrical failure; in which unexpected pump motor operations will occur. Also; the AUTOMIX system may intermittently experience an electrical failure where thec
Baxter Healthcare Corp. Aug-08-2012 AUTOMIX Plus – AUTOMIX Plus High Speed Compounder System; product 2M8075; automated nutrition compounders; Product Usage: The Automix Compounder Systems are electromechanical positive displacement fluid compounding devices used in the admixture of large volume parenteral nutrition formulations via gravimetric weighing. After fluid ingress into the keypad of the AUTOMIX Compounder’s (AUTOMIX) control module; the AUTOMIX may generate an incorrect device response to an AUTOMIX operator’s key press. Also; the AUTOMIX system may experience an intermittent electrical failure; in which unexpected pump motor operations will occur. Also; the AUTOMIX system may intermittently experience an electrical failure where thec
Baxter Healthcare Corp. Aug-08-2012 AUTOMIX – AUTOMIX High Speed Compounder System; product 2M8077; automated nutrition compounders; Product Usage: The Automix Compounder Systems are electromechanical positive displacement fluid compounding devices used in the admixture of large volume parenteral nutrition formulations via gravimetric weighing. After fluid ingress into the keypad of the AUTOMIX Compounder’s (AUTOMIX) control module; the AUTOMIX may generate an incorrect device response to an AUTOMIX operator’s key press. Also; the AUTOMIX system may experience an intermittent electrical failure; in which unexpected pump motor operations will occur. Also; the AUTOMIX system may intermittently experience an electrical failure where thec
Nellcor Puritan Bennett Inc. (dba Covidien LP) Aug-10-2012 Shiley – Shiley Reusable Cannula Low Pressure Cuffed Tracheostomy Tubes; model numbers (Worldwide) 8LPC; 8FEN; (Outside U.S.) 8FENJ; 8FENJ-S; 8LPC-S; 8FEN-S. Product Usage: The product is intended for use to bypass upper airway obstructions; provide long term ventilation; support and/or manage tracheal/bronchial secretions. The product is sold as sterile. The packaging may indicate either Covidien or Tyco as the manufacturer as the firm has transitioned from Tyco to Covidien over the past 4 years. Covidien is recalling certain cuffed Shiley tracheostomy tubes due to consumer complaints related to the connections and functions of the inner and outer cannula which were observed during mechanical ventilation of patients.
Stryker Instruments Div. of Stryker Corporation Aug-15-2012 Neptune Waste Management System – Neptune Waste Management System Instructions For Use ; Neptune Rover(120V); Neptune Rover (230 V).Intended for use in the surgical environment or physician’s office to collect and dispose of surgical fluid waste. Stryker received one report of a fatality from a customer in which the Neptune Rover was connected to a passive chest drainage tube post-operatively. Connecting the Neptune Rover (a high vacuum/high flow device); instead of using a post-operative low suction application; may have resulted in hemorrhage; which led to death.
Stryker Instruments Div. of Stryker Corporation Aug-15-2012 Neptune Waste Management System – Neptune Bronze Rover Waste Management System Instructions For Use.Intended for use in the surgical environment or physician’s office to collect and dispose of surgical fluid waste. Stryker received one report of a fatality from a customer in which the Neptune Rover was connected to a passive chest drainage tube post-operatively. Connecting the Neptune Rover (a high vacuum/high flow device); instead of using a post-operative low suction application; may have resulted in hemorrhage; which led to death.
Stryker Instruments Div. of Stryker Corporation Aug-15-2012 Neptune Waste Management System – Neptune 2 Rover Ultra (120 V and 230 V) Waste Management System Instructions For Use Intended for use in the surgical environment or physician’s office to collect and dispose of surgical fluid waste. Stryker received one report of a fatality from a customer in which the Neptune Rover was connected to a passive chest drainage tube post-operatively. Connecting the Neptune Rover (a high vacuum/high flow device); instead of using a post-operative low suction application; may have resulted in hemorrhage; which led to death.
Stryker Instruments Div. of Stryker Corporation Aug-15-2012 Neptune Waste Management System – Neptune International Gold Rover Waste Management System Instructions For Use for 230V system.Intended for use in the surgical environment or physician’s office to collect and dispose of surgical fluid waste. Stryker received one report of a fatality from a customer in which the Neptune Rover was connected to a passive chest drainage tube post-operatively. Connecting the Neptune Rover (a high vacuum/high flow device); instead of using a post-operative low suction application; may have resulted in hemorrhage; which led to death.
CareFusion 303; Inc. Aug-15-2012 Alaris Pump Module model 8100 – Alaris Pump Module model 8100.Subsequent product code: FPAThe Pump module is intended for facilities that utilize infusion for the delivery of fluids; medications; blood; and blood products using continuous or intermittent delivery through clinically acceptable routes of administration; such as; intravenous (IV); intra-arterial (IA);subcutaneous; epidural; enteral; or irrigation of fluid spaces. The Pump module is indicated for use on adults; pediatrics; and neonates. The recall was initiated because Carefusion identified a potential risk associated with the Alaris Pump module model 8100. Carefusion has received reports of customers experiencing motor stalls during infusion with Alaris Pump Module (model 8100) manufactured between August 2010 and July 2011.
Synthes USA HQ; Inc. Aug-16-2012 Synthes(R) Hemostatic Bone Putty – Synthes(R) Hemostatic Bone Putty; Part numbers 08.901.001.97S; 08.901.001.98S; 08.901.001.99S; 08.901.001D; and VB1025.10S.Indicated for use as a water soluble implant material and for use in the control of bleeding from bone surfaces. There is the potential for Hemostatic Bone Putty to ignite if contacted with electrosurgical cautery systems under certain conditions during surgery.
CareFusion 303; Inc. Aug-17-2012 Alaris Pump Module Model 8100 – Alaris Pump Module Model 8100 (formerly Medley Pump Module)Subsequent Product Code: FPA.The Pump module is intended for facilities that utilize infusion for the delivery of fluids; medications; blood; and blood products using continuous or intermittent delivery through clinically acceptable routes of administration; such as; intravenous (IV); intra-arterial (IA);subcutaneous; epidural; enteral; or irrigation of fluid spaces. The Pump module is indicated for use on adults; pediatrics; and neonates. The recall was initiated because Carefusion has identified a potential risk associated with the Alaris Pump module model 8100. The pump module door keypad overlay may separate from the keypad assembly
I-Flow Corporation Aug-28-2012 ON-Q pump with ONDEMAND bolus button – ON-Q pump with ONDEMAND bolus button; ON-Q C-bloc with ONDEMAND; ON-Q C-bloc with Select a Flow and ONDEMAND Model/Reference #: 7000180; 7000181; 7000182; 7000367; 7000397; CB003; CB005; CB006; P400X1-7+5/60; P400X2-14+5/30; P400X5+5/60; and PMB01. Part Numbers: 101347100; 101347300; 101347400; 101360200; 101368400; 101368600; 101368700; 102987000; 102987200; 102987300; 103161800; 103534300; 5001438; 5001470; 5001651; 5001780; 5001808; 5001809; 5001812; 7000180; 7000181; 7000182; & 7000367.Indicated for continuous and or intermittent delivery of medication to or around surgical wound sites and or close proximity to nerves. It was determined that in a small quantity of ON-Q pumps with ONDEMAND; the bolus button may not lock in the down position when depressed and/or the orange bolus refill indicator may stay in the lowermost position. As a result; the patient may receive continuous infusion at a rate greater than expected.
GE OEC Medical Systems; Inc Aug-28-2012 OEC IT3000; IT2500 (EnTrak); IT2500 Plus (EnTrak Plus); IT3500 (InstaTrak); IT3500 Plus (InstaTrak P – OEC IT3000; IT2500 (EnTrak); IT2500 Plus (EnTrak Plus); IT3500 (InstaTrak); IT3500 Plus (InstaTrak Plus); ConneCTstat; and ConneCTstat Plus picture archiving and communications systems. The systems are an aid to locate anatomical structures during open or percutaneous surgical procedures. It is intended for use in medical conditions that may benefit from the use of stereotactic surgical technique. The system provides a reference to rigid anatomical structures such as sinus; skull; long bone; or vertebra; which are visible on medical images such as CT; MRI; or X-ray. GE Healthcare Surgery had discovered that using the Inverted Headset Placement is not a validated configuration with the IT 3000; 2500; 2500 plus; 3500; 3500 plus; ConneCTstat; and ConneCTstat Plus Surgical Navigation equipment.
Class II recalls
Recalling Manufacturer, Date Posted, Trade Name/Product, Reason for Recall
Recalling Manufacturer Date Posted Trade Name/Product Reason for Recall
Perkinelmer Aug-01-2012 Perkin Elmer Genetic Screening Processor (GSP) – Perkin Elmer Genetic Screening Processor (GSP)Product Code: 2021-0010Product Usage: The GSP instrument is a fully automated; high throughput batch analyzer for time- resolved and prompt fluorescence analysis of samples in microtitration plates. It is intended for in vitro quantitative / qualitative determination of analytes in body fluids. The reagent kits running on the GSP instrument are used to test blood specimens dried on filter paper as an aid in screening newborns for congenital disorders. Currently assays for the determination of T4; TSH; 17OHP; IRT and GALT are cleared and available for use with the GSP instrument. Contamination from GSP Shaker unit results in decreased signal activity of assay measurements for Genetic Screening for Neonatal IRT; TSH and IRT
Steris Corporation Aug-01-2012 RELIANCE¿ 130 and 130L CART WASHER – The Reliance 130 and 130L Cart Washer/Disinfector is a high capacity mechanical washer intended for use in the washing; low-level disinfecting; and drying of carts; utensils; beds and other miscellaneous reusable items used in the care of patients at healthcare facilities / Crated for shipping. To ensure that users are properly operating the Reliance 130 and 130L Cart Washers; a door close confirmation button and door open delay will be installed on your cart washer.
GE OEC Medical Systems; Inc Aug-01-2012 UroView 2800 – UroView 2800; MDL number A349855.Product Usage: Designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic; surgical; and interventional procedures. Clinical application may include but are not limited to urologic and endoscopic procedures. The system may be ued for other imaging applications at the physician’s discretion. Please be aware that this is not a new recall. The firm has taken action; but; due to administrative issues this recall is now being classified by the Agency. GE OEC had discovered an issue with the hard disk drives that were installed on OEC device models: UroView 2800; 9800 Plus Digital; MiniView 6800; and FlexiView 8800 Mobile C-Arm. The devices were manufactured between October 15; 2004 and
GE OEC Medical Systems; Inc Aug-01-2012 OEC 9800 Plus – OEC 9800 Plus Digital; MDL number A349855.Product Usage: Is designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic; surgical and interventional procedures. Clinical applications may include cholangiography; endoscopic; urologic; orthopedic; neurologic; vascular; cardiac; critical care and emergency room procedures. The system may be used for other imaging applications at the physician’s discretion. Please be aware that this is not a new recall. The firm has taken action; but; due to administrative issues this recall is now being classified by the Agency. GE OEC had discovered an issue with the hard disk drives that were installed on OEC device models: UroView 2800; 9800 Plus Digital; MiniView 6800; and FlexiView 8800 Mobile C-Arm. The devices were manufactured between October 15; 2004 and
GE OEC Medical Systems; Inc Aug-01-2012 OEC MiniView 6800 Mobile – OEC MiniView 6800 Mobile; MDL number A349855.Product Usage: The mini 6800 digital mobile c arm is designed to provide the physician with general fluoroscopic visualization of the patient including but not limited to surgical; orthopedic; and extremity imaging. The device is not intended for whole body pediatric imaging. Please be aware that this is not a new recall. The firm has taken action; but; due to administrative issues this recall is now being classified by the Agency. GE OEC had discovered an issue with the hard disk drives that were installed on OEC device models: UroView 2800; 9800 Plus Digital; MiniView 6800; and FlexiView 8800 Mobile C-Arm. The devices were manufactured between October 15; 2004 and
Integra LifeSciences Corp. Aug-01-2012 "Integra¿ Advansys Medial Lisfranc Plate (MLP) – Integra¿ Advansys Medial Lisfranc Plate (MLP); Integra; 311 Enterprise Drive; Plainsboro; NJ 08536The Advansys plates are intended for bone fixation such as: Arthrodesis of the 1st metatarsocuneiform joint to reposition and stabilize a metatarsus primus varus; Lisfranc arthrodesis; Mono or bi-cortical osteotomies or fractures near the 1st metatarsocuneiform joint." Incorrect technique applied may cause potential rupture of the tibialis anterior tendon during surgery.
Abbott Point Of Care Inc. Aug-02-2012 I-STAT EG7+ Cartridge – I-STAT EG7+ Cartridge Abbott Point of Care; Princeton; NJ.The i-Stat EG7 cartridge is intended to be used for quantitatively measure sodium; potassium; ionized calcium; oxygen; carbon dioxide; partial pressure in arterial; venous; or capillary whole blood. i-Stat EG7 cartridges may generate falsely depressed PCO2 results for samples above 26 mm hg when stored at room temperature for four weeks or longer.
Stryker Instruments Div. of Stryker Corporation Aug-02-2012 Stryker Radiofrequency (RF) cannula – RF Cannula; 100 mm;Curved 10 MM; 20 G; REF 0406-630-125 RX only; Disposable ( 10/pk)Product Usage:The Stryker RF Cannulae; in combination with the Stryker RF Generator/Multi- Gen and electrodes; are intended for coagulation of soft tissue in orthopedic; arthroscopic; spinal; and neurosurgical applications. Stryker has received 6 complaints that the 5mm needle was placed in 10 mm package and 10 mm needle was placed in the 5 mm package. If the clinician does not recognize that the active tip on the cannula is 10 mm instead of 5mm and the cannula is used in a cervical procedure there is a potential for a thermal skin lesion due to a larger lesion creation. If the 10 mm active tip cannula; as opposed
Stryker Instruments Div. of Stryker Corporation Aug-02-2012 Stryker Radiofrequency (RF) cannula – RF Cannula; 100 mm;Curved 5 MM; 20 G; REF 0406-630-115 RX only; Disposable ( 10/pk)Product Usage:The Stryker RF Cannulae; in combination with the Stryker RF Generator/Multi- Gen and electrodes; are intended for coagulation of soft tissue in orthopedic; arthroscopic; spinal; and neurosurgical applications. Stryker has received 6 complaints that the 5mm needle was placed in 10 mm package and 10 mm needle was placed in the 5 mm package. If the clinician does not recognize that the active tip on the cannula is 10 mm instead of 5mm and the cannula is used in a cervical procedure there is a potential for a thermal skin lesion due to a larger lesion creation. If the 10 mm active tip cannula; as opposed
Baxter Healthcare Renal Div Aug-02-2012 Extraneal & Dineal PD Solution w/Automated PD Set w/Cassette – Extraneal and/or DIANEAL LOW CALCIUM Peritoneal Dialysis Solution in Plastic Container; PL-146 used with Automated Peritoneal Dialysis System/Automated PD Set with Cassette; Manufactured for Baxter Healthcare Corporation; Deerfield; IL 60015 U.S.A. The HomeChoice dialysis system is a personal cycler automated peritoneal dialysis system for pediatric and adult renal patients with fill volumes ranging from 60 mL to 3000 mL. DIANEAL Low Calcium peritoneal dialysis solutions are indicated for use in chronic renal failure patients being maintained on peritoneal dialysis. – and- The Personal Cycler Peritoneal Dialysis System [cycler and ancillary sets] is used for automatic control of dialysate solution exchanges in treatment of renal failure patients undergoing peritoneal dialysis. The Personal Cycler System automatically cycles a prescribed volume of dialysis solution into and out of the peritoneal cavity during the dialysis treatment. Baxter discovered that a Baxter technical service representative was providing incorrect instructions for inspection of solution bags for a blocked frangible prior to connection to the Automated PD Set with Cassette.
ICU Medical; Inc. Aug-02-2012 Stopcock – High Pressure Stopcock (3-Way; Luer Lock; Off).Product Usage:For IV. The firm initiated the recall due to a molding defect in a high pressure stopcock where a smallpercentage of the side ports could become totally occluded.
ICU Medical; Inc. Aug-02-2012 Cardiac Catheterization Waste Management System – Cardiac Catheterization Waste Management System w/1000mL Waste Bag; 2 Fluid Admin SetsProduct Usage:For waste managment. The firm initiated the recall due to a molding defect in a high pressure stopcock where a smallpercentage of the side ports could become totally occluded.
ICU Medical; Inc. Aug-02-2012 Stopcock – 94" (239cm) 20 Drop Admin Set w/High Pressure 4-Way (300 psi)Stopcock; Rotating Luer; Non-DEHP Tubing The firm initiated the recall due to a molding defect in a high pressure stopcock where a smallpercentage of the side ports could become totally occluded.
ICU Medical; Inc. Aug-02-2012 Flush Kit – Flush Kit w 3 Way Off StopcockProduct Usage:Flush Kit The firm initiated the recall due to a molding defect in a high pressure stopcock where a smallpercentage of the side ports could become totally occluded.
SCC Soft Computer Aug-03-2012 Soft Lab – SoftLab with SA INST versions: 3.1.6.12; 4.0.1.26-4.0.1.32; 4.0.2.21-4.0.2.51; and 4.0.3.5-4.0.3.13. Product UsageSoftLab is a laboratory information system to be used in a medical research or clinical laboratory by knowledgeable; trained; and experienced personnel. SoftLab enables the user to handle data-processing and laboratory activities; for the purpose of storing; managing; querying; and reporting laboratory data. On 10/17/2011 SCC Soft Computer; Clearwater; FL initiated a correction on SoftLab with SA INST versions: 3.1.6.12; 4.0.1.26-4.0.1.32; 4.0.2.21-4.0.2.51; and 4.0.3.5-4.0.3.13. A client reported an issue which caused two different sets of results from the Sysmex series of Hematology instruments to display under the same order on the instrument menu.
Transenterix; Inc Aug-03-2012 SPIDER Surgical Instrument: Flexible Clip Applier – SPIDER Surgical Instrument: Flexible Clip ApplierThe SPIDER¿ Surgical Instruments are intended for use in minimally invasive surgical procedures for grasping; mobilizing; dissecting; retracting; cutting; cauterizing; ligating; suction/irrigation and other manipulation of tissues and vessels during a laparoscopic procedure under direct and/or endoscopic visualization. Some clip applier units may be inadequate to achieve clip closure.
Smith & Nephew; Inc. Endoscopy Division Aug-03-2012 Smith and Nephew Inc. – Smith & Nephew 5.5 mm Dyonics Bonecutter ;ElectrobladeFull Radius Part Number: 7205962Product Usage:The Dyonics Electroblade Resector is indicated for use in arthroscopic surgical procedures of large and small articular cavities. The Dyonics Electroblade Resector is effective in soft and osseous tissue resection and in hemostasis of bleeding vessels. It is intended for arthroscopic procedures using saline solution; Ringers lactate or other conductive solutions as an irrigant under direct or video assisted fiberoptic visualization. Device labeled with an expiry period of 48 months instead of 36 months; an additional 12 months for which product and package reliability has not been validated.
Smith & Nephew; Inc. Endoscopy Division Aug-03-2012 Smith and Nephew Inc. – Smith & Nephew Dyonics Electroblade Resector; 4.5mm Full Radius Blade; BONECUTTERPart Number: 72202213Product Usage:The Dyonics Electroblade Resector is indicated for use in arthroscopic surgical procedures of large and small articular cavities. The Dyonics Electroblade Resector is effective in soft and osseous tissue resection and in hemostasis of bleeding vessels. It is intended for arthroscopic procedures using saline solution; Ringers lactate or other conductive solutions as an irrigant under direct or video assisted fiberoptic visualization. Devices labeled with an expiry period of 48 months instead of 36 months; an additional 12 months for which product and package reliability has not been validated.
Tango3 LLC Aug-03-2012 TANGO3 Water Storage Tank with Ozone Disinfection System – TANGO3 Water Storage Tank with Ozone Disinfection System; Tango3; LLC; 132 Citizens Blvd.; Simpsonville; KY 40067. Models are WOZ-250-PE; WOZ-240-SS; WOZ-180-SS. The TANGO3 Water Storage Tank with Ozone Disinfection System is intended to be used for disinfection of the water distribution system of a dialysis facility. During an FDA inspection; the firm was notified of Quality System deficiencies; which included lack of procedures for design control and customized modifications that were either not reviewed or received proper clearance from FDA. There was no assurance that all systems in the field were working properly and operating at a minimum of 0.2ppm of ozone.
Linvatec Corp. dba ConMed Linvatec Aug-06-2012 CrossFT Punch – CrossFT Punch; Product Number PFT-45M. Manufacturer: CONMED LINVATEC. The intended use is to create a hole to facilitate insertion of the CrossFT suture anchor into bone. ConMed Linvatec recalled lot number #156920; PFT-45M; CrossFT Punch because there is a possibility that the device was etched incorrectly listing the item number as PFT-00M and includes incorrect depth lines for insertion.
FMS; Finapres Medical Systems BV Aug-06-2012 Finapres Portapres Ambulatory Continuous Non-Invasive Blood Pressure Monitor – Finapres Medical Systems Portapres with NiMh battery packProduct Usage:Continuously measure blood pressure; The Portapres can be worn on the body with a protective waist belt. The device can be used without mains; in that case a battery pack is used. Battery may become hot and leak
Encore Medical; Lp Aug-06-2012 djo surgical6.5 mm cancellous bone screw – djo surgical Screw 6.5 mm; Sz 25mm; low profile.Product is intended for the fixation of the acetabular shell or fracture repair One lot of the 010-55-030; 6.5 mm Cancellous Bone Screw was recalled because a product complaint identified a mislabeling of the device. Although the package label indicates Size 30mm; the screw dimension is actually 25mm.
Apheresis Technologies; Inc. Aug-06-2012 Pump; blood; extra-luminal – Plasma Pump Model PP-04aUsed with Asahi Plasmaflo Plasma Separators and plasma exchange tubesets to perform therapeutic plasma exchange. On 07/09/2012; Apheresis Technologies; Inc. initiated a recall on the Plasma Pump Model PP-04a due to a complaint received regarding a rotor of the PP-04a pump that stopped during a therapeutic plasma exchange treatment causing interruption of flow of both the plasma discard line and replacement fruit line.
Linvatec Corp. dba ConMed Linvatec Aug-06-2012 PopLok Punch – PopLok Punch labeled in part:"PKL-35M***3.5mm***QTY 1***PopLok Punch***ConMed Linvatec Biomaterials; Ltd. Hermiankatu 6-8L 33720 Tampere; FINLAND***Rx Only***ConMed Linvatec 11311 Concept Blvd Largo; FL 33773-4908 USA***Made in USA***"Intended Use: Bone Punch. ConMed Linvatec recalled one lot of their PopLok bone Punch 3.5MM because the metal shaft diameter is 4.5mm when it should have been 3.5mm.
Greiner Bio-One North America; Inc. Aug-07-2012 3mL 9NC Coagulation Sodium Citrate 3.2% – 3mL 9NC Coagulation Sodium Citrate 3.2%; Item #454334;Greiner Bio-One North America Inc.; 4238 Capital Drive; Monroe; NC 28110.Intended Use: Venous blood collection tubes. Part of the lot received a lower concentration of citrate solution which may cause falsely lower values for common coagulation tests.
Stryker Spine Aug-07-2012 Stryker LUXOR RETRACTOR – LUXOR RETRACTOR BASE; Catalog Number: 48250030; Manufactured by: STRYKER Spine SAS; Z.I MARTICOT-33610-CESTAS-FRANCE; Distributed in the USA by: Stryker Spine. 2 Pearl Ct. Allendale; NJ 07401.Provides access to the thoracic and lumbar spine from a posterior approach via a small incision. Stryker received three reports involving blades of the Luxor Retractor becoming disassembled from the base causing the retractor to collapse insitu.
Varian Medical Systems; Inc. Oncology Systems Aug-08-2012 Varian – Varian brand Varian ARIA Oncology Information System; Import Exportapplication; v 11.0; Reference/FSCA Identifier: CP-08847; Model Number: HIT; Product is manufactured and distributed by Varian Medical Systems Inc.; Palo Alto; CA The ARIA Radiation Oncology product is a treatment plan and image management application. It enables the authorized user to enter; access; modify; store and archive treatment plan and image data from diagnostic studies; treatment planning; simulation; plan verification and treatment. ARIA Radiation Oncology also stores the treatment histories including dose delivered to defined sites and provides tools to verify performed treatments. ARIA also includes optional tools to manage the oncology department’s clinical and business information. A software anomaly has been identified with the Import Export Application version 11.0 whereMLC leaf positions for plans using BrainLab m3 and mMLC are incorrectly imported.
Afassco Inc Aug-08-2012 Afassco Finger Cots – The finger cots are made out of natural rubber. They are disposable products used to cover a fingertip bandage when working with liquids and are intended to keep the fingertip bandage dry. Cots are packed in clear plastic boxes; with 60 cots in a boxThey are disposable products used to cover a fingertip bandage when working with liquids and are intended to keep the fingertip bandage dry The firm is initiating a field correction because the product(s) were missing the Latex Warning Label. Afassco Inc. is implementing a voluntary field correction for MULTI-COLORED FINGER COTS because product lacked the warning label:"CAUTION: This product contains Natural Rubber Latex which may cause allergic reactions."
Philips Healthcare Inc. Aug-08-2012 Philips – Philips MultiDiagnost Eleva with Flat Detector (MD Eleva FD)Model: 708034Product Usage:Philips X-ray System When doing a 3 Dimensional Rotational Angiography (3DRA) the 3D reconstruction does not always start; even when all images have been acquired.
Abbott Point Of Care Inc. Aug-08-2012 I-STAT PT/INR cartridges – I-STAT PT/INR cartridge Abbott Point of Care Inc. Abbott Park; IL 60064 USAThis cartridge is useful for monitoring patients receiving oral anticoagulation therapy such as Coumadin or warfarin. The i-STAT PT/INR cartridges have the potential to exhibit incorrectly elevated results.
Radiometer America Inc Aug-08-2012 ABL 700 blood gas analyzer – The ABL software version 6.12 for the ABL800 and ABL700 analyzer. The analyzers are intended for the in Vitro testing of: -Samples of whole blood for the parameters pH; pO2; pCO2;cK+; cNa+; cCa2+; cCl-; cGlu; cLac; cCrea; ctBil; and co-oximetry parameters (ctHb; sO2; and the hemoglobin fractions FO2Hb; FCOHb; FMetHb; FHHb and FHbF)-Samples of expired air for the parameters pO2 and pCO2-Pleura samples for the pH parameter.The ABL software version 6.12 for the ABL800 and ABL700 analyzer. The analyzers are intended for the in Vitro testing of: -Samples of whole blood for the parameters pH; pO2; pCO2; cK+; cNa+; cCa2+; cCl-; cGlu; cLac; cCrea; ctBil; and co-oximetry parameters (ctHb; sO2; and the hemoglobin fractions FO2Hb; FCOHb; FMetHb; FHHb and FHbF) -Samples of expired air for the parameters pO2 and pCO2 -Pleura samples for the pH parameter. A customer has reported an error on an ABL8xx configured to a Hospital Information System using the data transfer protocol HL7 version 2.5. If the instrument transmits results to a HIS system and the connection is broken the results are queued for later transmission. If the ABL and HIS system are configured with HL7 2.5; any results in the queue will be mixed up when the instrument transmits t
Radiometer America Inc Aug-08-2012 The ABL90 FLEX analyzer – ABL90 FLEX software version 2.7 MR3.The ABL90 FLEX analyzer is intended for in vitro testing of samples of heparinized whole blood. A customer has reported an error on an ABL8xx configured to a Hospital Information System using the data transfer protocol HL7 version 2.5. If the instrument transmits results to a HIS system and the connection is broken the results are queued for later transmission. If the ABL and HIS system are configured with HL7 2.5; any results in the queue will be mixed up when the instrument transmits t
Radiometer America Inc Aug-08-2012 ABL 800 FLEX blood gas analyzer – The ABL software version 6.12 for the ABL800 analyzer. The analyzers are intended for the in Vitro testing of: -Samples of whole blood for the parameters pH; pO2; pCO2;cK+; cNa+; cCa2+; cCl; cGlu; cLac; cCrea; ctBil; and co-oximetry parameters (ctHb; sO2; and the hemoglobin fractions FO2Hb; FCOHb; FMetHb; FHHb and FHbF)-Samples of expired air for the parameters pO2 and pCO2-Pleura samples for the pH parameter.The ABL software version 6.12 for the ABL800 and ABL700 analyzer. The analyzers are intended for the in Vitro testing of: -Samples of whole blood for the parameters pH; pO2; pCO2; cK+; cNa+; cCa2+; cCl-; cGlu; cLac; cCrea; ctBil; and co-oximetry parameters (ctHb; sO2; and the hemoglobin fractions FO2Hb; FCOHb; FMetHb; FHHb and FHbF) -Samples of expired air for the parameters pO2 and pCO2 -Pleura samples for the pH parameter. A customer has reported an error on an ABL8xx configured to a Hospital Information System using the data transfer protocol HL7 version 2.5. If the instrument transmits results to a HIS system and the connection is broken the results are queued for later transmission. If the ABL and HIS system are configured with HL7 2.5; any results in the queue will be mixed up when the instrument transmits t
Straumann USA; LLC Aug-08-2012 Straumann – Straumann Narrow CrossFit (NC) Screw for CARES Abutment ZrO2. Endosseous dental implantArticle Number: 027.2650Product Usage:Dental implants are intended for surgical placement in maxillary and/or mandibular arches to provide support for prosthetic restorations using a Straumann Narrow CrossFit CARES ZrO2 Abutment in edentulous or partially edentulous patients. Dental implants are intended for immediate placement and function on single-tooth and/or multiple tooth applications when good primary stability is achieved; with appropriate occlusal loading; in order to restore chewing function a Straumann Narrow CrossFit CARES ZrO2 abutment is attached by screw to the dental implant. Multiple tooth applications may be rigidly splinted. In the case of edentulous patients; four or more implants must be used. Incorrect Screw (RC) included with NC CARES Abutment Set was not a Narrow CrossFit (NC) Screw for CARES NC Abutment ZrO2
Biomet 3i; LLC Aug-08-2012 Full OSSEOTITE Tapered Certain Implant – ***REF IFNT611***Full OSSEOTITE Tapered Certain Implant 6 x 11.5mm***Sterile by radiation***Rx Only***BIOMET 3i Dental Iberica S.L. WTC Almeda Park; Ed; 1; Planta 1 Pl. de la Pau s/n08940 Cornella de Llobregat (Barcelona) Spain. Lot #2011110798.Intended for surgical placement in the upper or lower jaw to provide a means for prosthetic attachment in single tooth restorations and in partially or fully endentulous spans with multiple single teeth utilizing delayed or immediate loading or with a terminal or intermediary abutment for fixed or removable bridge work and to retain over dentures. Biomet 3i is recalling their product Full Osseotite Tapered Certain Implant IFNT611. The depth of the implant’s internal hex is too shallow. The condition; if present; may prevent the driver; cover screw or abutment from fully engaging the implant.
Siemens Healthcare Diagnostics; Inc. Aug-09-2012 Siemens syngo(R) Lab Data Manager – Siemens syngo(R) Lab Data Manager.The syngo(R) Lab Data Manager is classified as a data calculator and processing module for use with In-vitro diagnostic devices. It also provides work flow management as well as remote instrument control to multiple interfaced instruments The recalling firm has discovered that when using a Sysmex(R) CA-7000 or CA-1500 coagulation analyzer with the syngo Lab Data Manager (LDM); there is a potential for the syngo LDM system; to display and transmit to the LIS an incorrect result following the syngo LDM’s application of the configured result number format. The problem is encountered when the result number format configured on the Sys
Abbott Point Of Care Inc. Aug-09-2012 i-Stat cTnl cartridges – i-Stat cTnl cartridgesAbbott Point of Care Inc.The i-Stat cTnl test is an in vitro diagnostic test for the quantitative measurement of cardiac troponin I in heparinized whole blood or plasma samples. Cardiac troponin I measurements can be used as an aid in the diagnosis and treatment of myocardial infarction and in the risk stratification of patients with acute coronary syndromes with respect to their relative risk of mortality. The cartridge is to be used with the i-Stat Analyzer; but not with the i-Stat Portable Clinical Analyzer or the Philips Medical System (formerly Agilent Technologies) Blood Analysis Module (BAM). As part of the i-Stat System; the cTnl test is to be used by trained health care professionals in accordance with a facility’s policies and procedures. The frequency of suppressed results for i-Stat cTnl; BNP and CK-MP cartridges is affected by atmospheric pressure.
Abbott Point Of Care Inc. Aug-09-2012 i-Stat BNP cartridges – i-Stat BNP cartridgesAbbott Point of Care Inc. The i-Stat BNP test is an in vitro diagnostic test for the quantitative measurement of B-type Natriuretic Peptide (BNP) in whole blood or plasma samples using EDTA as the anticoagulant. BNP measurements can be used as an aid in the diagnosis and assessment of the severity of congestive heart failure. The frequency of suppressed results for i-Stat cTnl; BNP and CK-MP cartridges is affected by atmospheric pressure.
Abbott Point Of Care Inc. Aug-09-2012 i-Stat CK-MP cartridges – i-Stat CK-MP cartridgesAbbott Point of Care Inc.The i-Stat CKMB test is an in vitro diagnostic test for the quantitative measurement of creatinine kinase MB mass in whole blood or plasma samples. CK-MB measurements can be used as an aid in the diagnosis and treatment of myocardial infarction (MI). The frequency of suppressed results for i-Stat cTnl; BNP and CK-MP cartridges is affected by atmospheric pressure.
Terumo Cardiovascular Systems Corporation Aug-09-2012 Terumo Advanced Perfusion System 1 – System 1 base 220/240VThe Terumo Advanced Perfusion System 1 is indicated for use in extracorporeal circulation of blood for arterial perfusion; regional perfusion; and cardiopulmonary bypass procedures only when used by a qualified perfusionist who is experienced in the operation of Sarns or similar equipment. Terumo Cardiovascular Systems sent a Safety Advisory (AA-2010-007-C) on December 2; 2010 (Recall# Z-0882/0883-2011 RES 57416) regarding malfunctions of the Occluder and Air Bubble Detection (ABD) Modules to a confined number of Terumo Advanced Perfusion System 1 users. The investigation of the malfunction found a faulty component on the modules’ application board caused the failures. Terumo CVS re
Terumo Cardiovascular Systems Corporation Aug-09-2012 Terumo Advanced Perfusion System 1 – System 1 base 100/120VThe Terumo Advanced Perfusion System 1 is indicated for use in extracorporeal circulation of blood for arterial perfusion; regional perfusion; and cardiopulmonary bypass procedures only when used by a qualified perfusionist who is experienced in the operation of Sarns or similar equipment. Terumo Cardiovascular Systems sent a Safety Advisory (AA-2010-007-C) on December 2; 2010 (Recall# Z-0882/0883-2011 RES 57416) regarding malfunctions of the Occluder and Air Bubble Detection (ABD) Modules to a confined number of Terumo Advanced Perfusion System 1 users. The investigation of the malfunction found a faulty component on the modules’ application board caused the failures. Terumo CVS re
Angiodynamics Worldwide Headquarters Aug-09-2012 Soft-Vu Angiographic Catheter – AngioDynamics Angiographic catheter — Soft-Vu (JB-1) Non-braided. — Size: 5F; Length: 100cm; designed to accept guidewire: .035 in. — Catalog No. [REF]: 10734201. Packaged in boxes of 5 catheters each; with manufacturer listed as AngioDynamics; Inc.; Queensbury; NY USA.Intended use: angiographic diagnosis. AngioDynamics is recalling one lot of Soft-Vu Angiographic catheters because one of the catheter pouches within the outer box may be mislabeled.
Siemens Healthcare Diagnostics; Inc. Aug-09-2012 Dimension(R) Reagent Management System (RMS) – Power Cord. – Dimension(R) Reagent Management System (RMS) – Power Cord.The Siemens Healthcare Diagnostics Dimension(R) clinical chemistry analyzers are floor model; fully automated; microprocessor-controlled; integrated instrument systems that use prepackaged Flex(R) reagent test cartridges to measure a variety of analytes in human body fluids. Siemens Healthcare Diagnostics has confirmed that partial insertion of the power cord on the Dimension Reagent Management System (RMS) power input module can cause the plug to overheat and potentially create a fire hazard. RMS without a power cord retention clip may be affected.
Smith & Nephew; Inc. Endoscopy Division Aug-09-2012 Smith & Nephew – Smith & Nephew 5.5 mm TWINFIX Ultra Ti Anchor with two #2 sutures (COBRAID-blue; COBRAIDblack); sterilePart Number: 72202896Product Usage: intended for use for thereattachment of soft tissue to bone Distal part of the anchor may break on insertion into bone during surgery
Smith & Nephew; Inc. Endoscopy Division Aug-09-2012 Smith & Nephew – Smith & Nephew 5.5 mm TWINFIX Ultra Ti Anchor with three #2 sutures (white; COBRAID- blue); sterilePart Number: 72202897Product Usage: intended for use for thereattachment of soft tissue to bone Distal part of the anchor may break on insertion into bone during surgery
Smith & Nephew; Inc. Endoscopy Division Aug-09-2012 Smith & Nephew – Smith & Nephew 5.5 mm TWINFIX Ultra Ti Suture Anchor with two #2 ULTRABRAID sutures (blue; blue-COBRAID) with NeedlesProduct Usage: intended for use for thereattachment of soft tissue to bonePart Number: 72202618 Distal part of the anchor may break on insertion into bone during surgery
Stryker Spine Aug-09-2012 Stryker Reliance AL Implant Blocker – Stryker Reliance AL Implant Blocker (Various sizes)The SLIDE Implant Blocker is a reusable instrument; sterilized prior to use. It allows the surgeon to distract the disc space in the lumbar region of the spine using an anterior or anterolateral approach while also allowing them to insert the implant into final position. Stryker Spine has received six reports regarding the breakage of one or more prongs at the extremity of the instrument.
Medical Specialties Distributors; Inc. Aug-09-2012 Medstream 81" (206cm) 20 Universal Administration Set with Y-Site – Medstream 81" (206 cm) 20 Drop Standard bore Universal Administration Set with Y-Site; SterileManufactured for MSD (Medical Specialties Distributors LLC; Stoughton; MA. Product of ChinaProduct Number: MS721 Disposable Infusion set Devices leaking at the Y-site
Smith & Nephew; Inc. Endoscopy Division Aug-09-2012 Smith & Nephew – Smith & Nephew 5.5 mm TWINFIX Ultra Ti Anchor with two #2 sutures(white; COBRAID-blue); sterilePart Number: 72202895Product Usage: intended for use for thereattachment of soft tissue to bone Distal part of the anchor may break on insertion into bone during surgery
Siemens Healthcare Diagnostics; Inc. Aug-09-2012 EasyLink Informatics System – EasyLink(TM) Informatics System; Part Number 1000034805. EasyLink(TM) Informatics System is classified as a data calculator and processing module for use with In-Vitro diagnostics devices. There is a potential for the EasyLink system to display and transmit to the Laboratory Information System networks an incorrect result following the EasyLink systems application of the configured result number format. The problem is encountered when the result number format configured on the Sysmex CA-7000 or CA-1500 coagulation analyzer does not match the EasyLink system settings on the following
Kimberly-Clark Corporation Aug-09-2012 Kimberly Clark Patient Warming System – Model 1000 Control Unit. – Kimberly Clark Patient Warming System – Model 1000 Control Unit. Kimberly Clark Patient Warming System – Model 1000 Control Unit and Energy Transfer Pads is a thermal regulating system; indicated for monitoring and controlling patient temperature. A defect of the "fuse holder" can lead to a Control Unit failure that may cause the device to lose its ability to warm and maintain set temperature and may also result in excessive heat with the fuse assembly that could lead to the generation of smoke.
JK Products & Services; Inc Aug-10-2012 Beauty Angel – BeautyAngel Health Fitness Natural Collagen Stimulation Anti AgingFor human use. The Beauty Angel was marketed without a 510k.
AGFA Corp. Aug-10-2012 IMPAX Cardiovascular (CV) Reporting – IMPAX Cardiovascular (CV) ReportingReporting tool used for structured reporting and structured report outputs (including XML style sheet customization and PDF) Content entered into the "Conclusions" free text box on the Report Writer screen was not represented on the final printed report.
Zimmer; Inc. Aug-10-2012 NCB Polyaxial Locking Plate System NCB screws – The NCB Polyaxial Locking Plate System NCB screws 26mm: 02.03155.026; non-sterileProduct is implantable screws indicated for temporary internal fixation and stabilization of fractures and osteotomies of long bones. These screws are intended for bicortical anchorage. Zimmer investigation following a complaint found one lot of NCB Polyaxial Locking Plate System NCB screws; 26mm; distributed in the United States contained incorrect 32 mm screws.
Edwards Lifesciences; LLC Aug-12-2012 Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters – Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model 131F7J.For use in patients who require hemodynamic monitoring. The device is being recalled because the firm received multiple complaints related to passage of a J-tip guidewire when inserted through the distal lumen hub of the catheter.
Edwards Lifesciences; LLC Aug-12-2012 Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters – Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model 131F7P.For use in patients who require hemodynamic monitoring. The device is being recalled because the firm received multiple complaints related to passage of a J-tip guidewire when inserted through the distal lumen hub of the catheter.
Edwards Lifesciences; LLC Aug-12-2012 Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters – Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model 131HF7J.For use in patients who require hemodynamic monitoring. The device is being recalled because the firm received multiple complaints related to passage of a J-tip guidewire when inserted through the distal lumen hub of the catheter.
Edwards Lifesciences; LLC Aug-12-2012 Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters – Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model 131HF7P.For use in patients who require hemodynamic monitoring. The device is being recalled because the firm received multiple complaints related to passage of a J-tip guidewire when inserted through the distal lumen hub of the catheter.
Edwards Lifesciences; LLC Aug-12-2012 Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters – Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model 131HVF7P.For use in patients who require hemodynamic monitoring. The device is being recalled because the firm received multiple complaints related to passage of a J-tip guidewire when inserted through the distal lumen hub of the catheter.
Edwards Lifesciences; LLC Aug-12-2012 Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters – Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model TS057HF7.For use in patients who require hemodynamic monitoring. The device is being recalled because the firm received multiple complaints related to passage of a J-tip guidewire when inserted through the distal lumen hub of the catheter.
Edwards Lifesciences; LLC Aug-12-2012 Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters – Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model 141HF7J.For use in patients who require hemodynamic monitoring. The device is being recalled because the firm received multiple complaints related to passage of a J-tip guidewire when inserted through the distal lumen hub of the catheter.
Edwards Lifesciences; LLC Aug-12-2012 Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters – Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model 141HF7P.For use in patients who require hemodynamic monitoring. The device is being recalled because the firm received multiple complaints related to passage of a J-tip guidewire when inserted through the distal lumen hub of the catheter.
Edwards Lifesciences; LLC Aug-12-2012 Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters – Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model 151F7.For use in patients who require hemodynamic monitoring. The device is being recalled because the firm received multiple complaints related to passage of a J-tip guidewire when inserted through the distal lumen hub of the catheter.
Edwards Lifesciences; LLC Aug-12-2012 Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters – Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model 151HF7.For use in patients who require hemodynamic monitoring. The device is being recalled because the firm received multiple complaints related to passage of a J-tip guidewire when inserted through the distal lumen hub of the catheter.
Edwards Lifesciences; LLC Aug-12-2012 Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters – Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model 141F7.For use in patients who require hemodynamic monitoring. The device is being recalled because the firm received multiple complaints related to passage of a J-tip guidewire when inserted through the distal lumen hub of the catheter.
Sentec AG Aug-13-2012 SenTec; V-Sign"2 Sensors – SenTec; V-Sign"2 Sensors The SenTec Digital Monitoring System (SMDS) is used for continuous and noninvasive real-time monitoring of ventilation (tcPCO2) and oxygenation (SpO2). SenTec is recalling a number of V-Sign"2 Sensors due to a problem regarding configuration parameter writing during manufacturing.
GE Healthcare; LLC Aug-13-2012 GE Healthcare Advantage Workstations – GE Healthcare Advantage Workstations; Advantage Worksation version 4.2 and 4.3 with Volume Viewer 2 (version 6.4-6.8) provided with Advance Vessel Analysis (AVA) and Advantage Workstation 4.4 with Volume Viewer 2 (version 6.8 or before) or Volume Viewer 3 (version 7.2 -7.3) provided with Advanced Vessel Analysis (AVA); Model 2378698-2Product Usage:Advantage Workstation version 4.2: The Advantage Workstation 4.2 is a review station; which allows easy selection; review; processing; filming and medial interchange of multi-modality images from a variety of diagnostic imaging systems. When interpreted by a trained physician; filmed images may be used as an element for diagnosis. Advantage Workstation version 4.3/4.4 : The Advantage Workstation 4.3 is a review station; which allows easy selection; review; processing; filming and medial interchange of multi-modality DIACOM images from a variety of diagnostic imaging systems. When interpreted by a trained physician; filmed images of the AW monitor may be used as a basis for diagnosis; except in the case of mammography. GE Healthcare is informing you of incorrect measurements when using the Aorta analysis protocol or customized protocols. Until a new software version is installed they are asking you not to use the aorta analysis protocol or the customized protocols for an aneurysm.A second issue was also discovered internally. When loading PET data into the Volume Viewer; ifslices are missing in a PET serie
Nico Corp. Aug-13-2012 13.5 mm x 60 mm BrainPath Sheath – 13.5 mm x 60 mm BrainPath SheathThe NICO BrainPath is a family of products that consists of multiple sized reusable and re-sterilizable obturators with coordinating single patient use; disposable sheaths (three lengths available for each: 50mm; 60mm; and 75mm). The obturator and sheath are assembled in the OR immediately prior to use. These two components are held together by an interference fit. The device when used as intended is designed to provide access to neurological tissues. BrainPath sheaths were mislabeled. Sheaths which measure 50mm were labeledas 60mm. The length callout on the label does not match the actual length of the sheath within thepackaging resulting in an improper fit as further explained below. This mislabeling wasdiscovered on 29-June-2012 during a clinical case.
Carestream Health; Inc. Aug-13-2012 Carestream DRX-1 System battery – Carestream DRX-1 System Battery — Made in U.S.A. for Carestream Health; Inc.; Carestream Health; Inc.; 150 Verona St; Rochester; NY 14608. — The battery may be sold with the DRX-1 imaging device or as a stand-alone accessory. Carestream DRX-1 System batteries manufactured before June 2012 due to two occurrences of lithium-ion battery overheating; which may cause burns.
Nico Corp. Aug-13-2012 13.5 mm x 50 mm BrainPath Sheath – 13.5 mm x 50 mm BrainPath SheathThe NICO BrainPath is a family of products that consists of multiple sized reusable and re-sterilizable obturators with coordinating single patient use; disposable sheaths (three lengths available for each: 50mm; 60mm; and 75mm). The obturator and sheath are assembled in the OR immediately prior to use. These two components are held together by an interference fit. The device when used as intended is designed to provide access to neurological tissues. BrainPath sheaths were mislabeled. Sheaths which measure 50mm were labeledas 60mm. The length callout on the label does not match the actual length of the sheath within thepackaging resulting in an improper fit as further explained below. This mislabeling wasdiscovered on 29-June-2012 during a clinical case.
International Technidyne Corp. Aug-14-2012 ITC ProTime Microcoagulation System – ProTime Microcoagulation System;Professional; Patient Self-Test.Intended for use in the quantitative determination of prothrombin time from finger stick whole blood or anticoagulant free venous whole blood. Intended for use in the management of patients treated with oral anticoagulants by a healthcare professional and for patient self-testing at home. ITC received a report regarding an incident with a ProTime instrument that overheated during charging.
Philips Healthcare Inc. Aug-15-2012 Philips Essenta DR; X-Ray System – Philips Essenta DR; X-Ray System; Diagnostic; general-purposeModel: 712070.The Essenta DR is a multifunctional stationary X-ray Intended Use From Labeling): system; in which the swivel arm rotation; the vertical movement of the swivel arm and the SID adjustment are motorized. It is designed for radiographic examination of the recumbent; standing or seated patient and also for lateral exposures. It enables the operator to quickly and safely move the unit to all the pre-programmed basic positions at the press of a button; using the autopositioning feature. Fine positioning of the tube/collimator and detector on the patient is easy to carry out using the command arm. Essenta DR C-Arm may fall
Maquet Inc. Aug-15-2012 Maquet Getinge Group Pediatric Arterial Cannula – Maquet Getinge Group Pediatric Arterial Cannula Maquet Cardiopulmonary AG Kehler Strabe 3176437 Rastatt Germany Phone +49 7222 932-0Fax: +49 7222 932-1888info.cp@maquet.comwww.maquet.comUsed to introduce blood and sterile solution to the circulation system during extracorporeal circulation procedures Certain pediatric arterial cannulas may have limited flexibility due to an increased length of the "hardened" cannula tip.
Philips Healthcare Inc. Aug-15-2012 Philips Easy Diagnost Classic-Stationary x-ray system – Philips Easy Diagnost Classic-Stationary x-ray systemCatalog Numbers: 70642; 70643; 706030; 706031; 706032Stationary x-ray system; Universal RF system for general use. Inclination switch in the stand may have been mounted incorrectly; as a result; the switch could not stop the tilting movement of the table base due tol hardware or software errors.
Ortho-Clinical Diagnostics Aug-15-2012 VITROS Chemistry Products Digoxin (DGXN) Slides – VITROS Chemistry Products DGXN Slides — [REF] 834 3386. Product is packaged in a box with multiple slides. The lot and expiration codes are found on the side of the package. Product Usage: Intended use: For in vitro diagnostic use only. VITROS Chemistry Products DGXN Slides quantitatively measure digoxin (DGXN) concentration in serum and plasma using VITROS 250/350/950/5;1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System. Ortho Clinical Diagnostics revised the VITROS Chemistry Products DGXN Slides Instructions for Use (IFU) and removed heparin plasma as a recommended specimen type for VITROS DGXN Slides
Roche Molecular Systems; Inc. Aug-15-2012 COBAS AmpliPrep Sample Input Barcode Clips – COBAS AmpliPrep Sample Tube Input Barcode Clips; catalog number 03137040001. Input S-tube barcode clips hold sample input tubes in the COBAS AmpliPrep Instrument (CAP) sample racks and have a barcode to identify the sample. Certain lots of COBAS AmpliPrep (CAP) S-tube Input (Box of 12 bags 12×24 S-tube and 12×24 S-clip) can cause the sample input tubes to stick in the barcode clips. As a consequence; the CAP instrument will lift both the sample input tube together with the barcode clip from the sample rack; resulting in an aborted run. No erroneous results would be produced if the issue occurs; but samples in proce
DePuy Orthopaedics; Inc. Aug-16-2012 DePuy Custom Implant Devices – DePuy Custom Implant DevicesPackaging: Packaging was not standardized on customs; it was dependant on the geometry of the productProduct Usage:Description: Devices meeting the regulatory definition of a custom medical device are those which are provided by prescription at a physician s request to meet a specific patient need and have been exempt from FDA premarket review under the Federal Food; Drug; and Cosmetic Act since 1976. Intended Use: See information contained in the Information for Use for Custom Implant Device (IFU-0902-00-500 rev C) In connection with a Warning Letter received from the U.S. Food & Drug Administration on December 9; 2011; DePuy Orthopaedics is taking steps to retrieve custom device implants that surgeons may have ordered from DePuy Orthopaedics; but not implanted. DePuy Orthopaedics received a Warning Letter from the FDA on December 9; 2011 regarding custom device implants. DePuy Orthopaedics has discontinue
Zimmer; Inc. Aug-16-2012 Trabecular Metal Reverse Shoulder Liner 40mm 65¿ Neck Angle – 00-4309-028-01 – Trabecular Metal Reverse Shoulder Liner 40mm 65¿ Neck AnglePer surgical technique 97-4309-003-00 Revision 4: "Complete Poly Liner insertion by snapping the appropriate 60¿ (Standard) or 65¿ (Retentive) Poly Liner Impactor to the Poly Liner Impactor Handle. Then; place the Poly Liner Impactor on the Poly Liner articular surface and forcefully strike the Poly Liner Handle with a mallet." Lot specific Trabecular Metal (TM) Reverse Shoulder Liner Impactors are being recalled due to reports of alignment peg fractures. All lots of TM Reverse Shoulder Liner Impactors manufactured from 455 stainless steel are being retrieved; as all reported fractured instruments were manufactured with thismaterial. The TM Reverse Shoulder Liner Impactor units that were manufactured with 13-8stain
Zimmer; Inc. Aug-16-2012 Trabecular Metal Reverse Shoulder Liner 36 mm 65¿¿ Neck Angle – 00-4309-029-01 – Trabecular Metal Reverse Shoulder Liner 36 mm 65¿¿ Neck AnglePer surgical technique 97-4309-003-00 Revision 4: "Complete Poly Liner insertion by snapping the appropriate 60¿ (Standard) or 65¿ (Retentive) Poly Liner Impactor to the Poly Liner Impactor Handle. Then; place the Poly Liner Impactor on the Poly Liner articular surface and forcefully strike the Poly Liner Handle with a mallet." Lot specific Trabecular Metal (TM) Reverse Shoulder Liner Impactors are being recalled due to reports of alignment peg fractures. All lots of TM Reverse Shoulder Liner Impactors manufactured from 455 stainless steel are being retrieved; as all reported fractured instruments were manufactured with thismaterial. The TM Reverse Shoulder Liner Impactor units that were manufactured with 13-8stain
Zimmer; Inc. Aug-16-2012 Trabecular Metal Reverse Shoulder Liner 40mm – Trabecular Metal Reverse Shoulder Liner 40mm; part 00-4309-028-00 – Per surgical technique 97-4309-003-00 Revision 4: "Complete Poly Liner insertion by snapping the appropriate 60¿ (Standard) or 65¿ (Retentive) Poly Liner Impactor to the Poly Liner Impactor Handle. Then; place the Poly Liner Impactor on the Poly Liner articular surface and forcefully strike the Poly Liner Handle with a mallet." Lot specific Trabecular Metal (TM) Reverse Shoulder Liner Impactors are being recalled due to reports of alignment peg fractures. All lots of TM Reverse Shoulder Liner Impactors manufactured from 455 stainless steel are being retrieved; as all reported fractured instruments were manufactured with thismaterial. The TM Reverse Shoulder Liner Impactor units that were manufactured with 13-8stain
Zimmer; Inc. Aug-16-2012 Trabecular Metal Reverse Shoulder Liner 36mm; Nonsterile – 00-4309-029-00- Trabecular Metal Reverse Shoulder Liner 36mm; NonsterilePer surgical technique 97-4309-003-00 Revision 4: "Complete Poly Liner insertion by snapping the appropriate 60¿ (Standard) or 65¿ (Retentive) Poly Liner Impactor to the Poly Liner Impactor Handle. Then; place the Poly Liner Impactor on the Poly Liner articular surface and forcefully strike the Poly Liner Handle with a mallet." Lot specific Trabecular Metal (TM) Reverse Shoulder Liner Impactors are being recalled due to reports of alignment peg fractures. All lots of TM Reverse Shoulder Liner Impactors manufactured from 455 stainless steel are being retrieved; as all reported fractured instruments were manufactured with this material. The TM Reverse Shoulder Liner Impactor units that were manufactured with 13-8 stainle
Philips Medical Systems (Cleveland) Inc Aug-17-2012 The Brilliance 64 and Ingenuity CT Computed Tomography Scanners – The Brilliance 64 and Ingenuity CT are whole body Computed Tomography X-Ray Systems intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. This device may include signal analysis and display equipment; patient; and equipment supports; components and accessories. 1. The current system design of software version 4.0.0xx379 does not prevent the system from scanning if the dose level exceeds a set upper dose limit for CT Brain Perfusion scanning; which previous versions did. However; the current version does have the Dose Check (NEMA XR-25) feature; which provides dose notifications and alerts; but it is possible for the user to disable Dose Check after ente
Biomet U.K.; Ltd. Aug-17-2012 Oxford Gap Gauge – Oxford Gap Gauge SML 3/4mm.The instrument is used for an intermediate check of the flexion and extension gaps when preparing the femur to accept the femoral component. A drafting error during an unrelated design change has led to 4 misleading dimensions on the drawing. The CAD modelremained the same thickness but the problem dimensions were accidentally struck from an incorrect point result in anincrease of 1.0mm in the value of each dimension
GE OEC Medical Systems; Inc Aug-17-2012 Fluoroscopic X-Ray System – GEHC OEC 8800 Mobile Fluoroscopic X-ray System; GE Healthcare; Surgery; Salt Lake City; UT.Mobile fluoroscopic examination of human anatomy. X-ray units did not meet manufacturer’s specification for linearity.
Conformis Inc Aug-17-2012 Conformis – Conformis iTotal CR-Cruciate Retaining Knee Replacement System Model Numbers:M57250600010 iTotal CR; Left KneeM57250600020 iTotal CR; Right KneeProduct Usage : Usage:The iTotal CR Knee Replacement System (KRS) is intended for use as a total knee replacement in patients with knee joint pain and disability whose conditions cannot be solely addressed by the use of a prosthetic device that treats only one or two of the three knee compartments; such as a unicondylar; patello-femoral or bi-compartmental prosthesis. Addendum Labeling iTotal CR Surgical Technique with Detailed Instructions of Total CR Poly Insertion Technique
DePuy Orthopaedics; Inc. Aug-17-2012 Altrx" Altralinked" Polyethylene liners – Altrx" Altralinked" Polyethylene linersDescription: An acetabular liner is one of the implants used during total hip arthroplasty to replace the damaged hip joint to help increase patient mobility and to reduce pain. Packaging: Product is placed into a PETG tray; sealed with a Tyvek lid. This is placed into a second PETG tray and sealed with a Tyvek lid. This package is placed into a paperboard carton; labeled; and shrink-wrapped. Intended Use: An acetabular liner is used in combination with other implants for total hip arthroplasty is intended to provide increased patient mobility and reduce pain by replacing the damaged hip joint articulation in patients where there is evidence of sufficient sound bone to seat and support the components. In the recalled lot; the products were not machined according to the production router; a size 52 cup (122136052) was machined instead. This resulted in a size 52 liner being etched and labeled as a size 54 liner.
Siemens Medical Solutions; USA; Inc Aug-17-2012 syngo Dynamics Version 9.5 – syngo Dynamics Version 9.5 If multiple uncompressed images/clips are sent to the syngo Dynamics server; around the same time; it is possible for an image from a patient to be placed in another patient’s study.
Siemens Healthcare Diagnostics; Inc Aug-20-2012 Siemens – Siemens ADVIA Centaur¿ Syphilis (SYPH) Assay ; 200 ReadyPack Reference Number 10492493Product Usage: The ADVIA Centaur Syphilis (SYPH) assay is an in vitro diagnostic immunoassay for the qualitative determination of antibodies to Treponema pallidum in human serum or plasma (EDTA; lithium or sodium heparinized; citrate) using the ADVIA Centaur and ADVIA Centaur XP systems as an aid in the diagnosis of syphilis Syphilis Assay Interference with HBsAg Assay
Beckman Coulter Inc. Aug-20-2012 UniCel DxH Slidemaker Stainer Stainer Floor Cabinet – UniCel DxH Slidemaker Stainer Stainer Floor Cabinet; PN A96152.The DxH Slidemaker Stainer is a fully automated slide preparation and staining device that aspirates a whole blood-sample; smears a blood film on a clean microscope slide; and delivers a variety of fixatives; stains; buffers; and rinse solutions to that blood smear. The DxH Slidemaker Stainer allows for adaptation of the smear appearance and stain methodology according to user preferences. Blood smears produced by the Slidemaker portion of the DxH Slidemaker Stainer are moved to baskets for transfer to the Stainer portion by a robot arm. Microscopic examination of the stained blood smears can be used to help determine the hematologic status of a patient. A stained blood film: " Allows for the differentiation of white blood cells " Facilitates the characterization of red blood cells and platelets " Aids in the identification of blood components and cellular abnormalities The optional floor stand has four drawers for storing the reagent and waste containers currently in use in the DxH Slidemaker Stainer. The recall was initiated because Beckman Coulter has confirmed that the DxH Slidemaker Stainer Floor Stand shipped with Slidemaker Stainer instruments were missing vinyl caps; exposing sharpt edges on the DxH Slidemaker Stainer Reagent Cabinet (Floor Stand) drawer slides. The sharp edges on the drawer slides may expose operators to physical injury when replacing reagents and waste containers whic
Beckman Coulter Inc. Aug-20-2012 UniCel DxH Slidemaker Stainer Instrument System – UniCel DxH Slidemaker Stainer Instrument System; PN 775222.The DxH Slidemaker Stainer is a fully automated slide preparation and staining device that aspirates a whole blood-sample; smears a blood film on a clean microscope slide; and delivers a variety of fixatives; stains; buffers; and rinse solutions to that blood smear. The DxH Slidemaker Stainer allows for adaptation of the smear appearance and stain methodology according to user preferences. Blood smears produced by the Slidemaker portion of the DxH Slidemaker Stainer are moved to baskets for transfer to the Stainer portion by a robot arm. Microscopic examination of the stained blood smears can be used to help determine the hematologic status of a patient. A stained blood film: " Allows for the differentiation of white blood cells " Facilitates the characterization of red blood cells and platelets " Aids in the identification of blood components and cellular abnormalities The optional floor stand has four drawers for storing the reagent and waste containers currently in use in the DxH Slidemaker Stainer. The recall was initiated because Beckman Coulter has confirmed that the DxH Slidemaker Stainer Floor Stand shipped with Slidemaker Stainer instruments were missing vinyl caps; exposing sharpt edges on the DxH Slidemaker Stainer Reagent Cabinet (Floor Stand) drawer slides. The sharp edges on the drawer slides may expose operators to physical injury when replacing reagents and waste containers whic
Exactech; Inc. Aug-21-2012 LOGIC Proximal Tibial Spacer Size 2.5 – OPTETRAK LOGIC Proximal Tibial Spacer & Screws (2) 2.5 LT BLUE Size 2.5; 8mm***STERILE***Match insert/spacer/tray color. Use with LOGIC Tibial Components. REF 02–012-42-2508.The Optetrak Comprehensive Knee Systems are indicated for use in skeletally mature individuals undergoing primary surgery for total knee replacement due to osteoarthritis; osteonecrosis; rheumatoid arthritis; and/or post-traumatic degenerative problems. They are also indicated for revision of failed previous reconstructions where sufficient bone stock and soft tissue integrity are present. The Optetrak Comprehensive Knee Systems are contraindicated in patients with active infection; patients without sufficient bone stock to allow appropriate insertion and fixation of the prosthesis; patients without sufficient soft tissue integrity to provide adequate stability; patients with either mental or neuromuscular disorders that do not allow control of the knee joint; and patients whose weight; age; or activity level might cause extreme loads and early failure of the system. Exactech; Inc. of Gainesville; FL recalled their Optetrak Proximal Tibial Spacer after the devices were determined to be dimensionally incompatible to mate as intended with the Logic Tibial Tray.
Terumo Cardiovascular Systems Corporation Aug-21-2012 CDl System 500 – Interface module for CDl System 500Product Usage:The Interface Module for CDl 500 is the interface between the CDl 500 monitor and the system. The module performs the following functions: Communicates primary pump flow data to the CDl 500 Receives blood parameter data from the CDl 500 Terumo Cardiovascular Systems has received reports of malfunctions involving the loss of data transfer capabilities using the data transfer capabilities using modules on the Terumo Advanced Perfusion System 1. Some reports stated that the odor of smoke was as associated with the failures. The malfunctions occurred during set-up; during cardiopulmonary bypass; and during routine testing of the modu
Terumo Cardiovascular Systems Corporation Aug-21-2012 CDI System 100/101 – Interface module for CDl System 100/101Product Usage:The Interface Module for CDl 500 is the interface between the CDl 500 monitor and the system. The module performs the following functions: Communicates primary pump flow data to the CDl 500 Receives blood parameter data from the CDl 500 Terumo Cardiovascular Systems has received reports of malfunctions involving the loss of data transfer capabilities using the data transfer capabilities using modules on the Terumo Advanced Perfusion System 1. Some reports stated that the odor of smoke was as associated with the failures. The malfunctions occurred during set-up; during cardiopulmonary bypass; and during routine testing of the modu
Terumo Cardiovascular Systems Corporation Aug-21-2012 System 1 – Serial interface module RS-232Product Usage:The System 1 provides perfusion case data transfer through the use of the data transfer module. This module is a general purpose serial interface and is the interface between the TLink Data Management ystem or Sarns CCPro Data Perfusion oftware and the system. The data collected and exported by the data transfer module includes physiological data and device events to record the progress and events during a procedure. Terumo Cardiovascular Systems has received reports of malfunctions involving the loss of data transfer capabilities using the data transfer capabilities using modules on the Terumo Advanced Perfusion System 1. Some reports stated that the odor of smoke was as associated with the failures. The malfunctions occurred during set-up; during cardiopulmonary bypass; and during routine testing of the modu
Terumo Cardiovascular Systems Corporation Aug-21-2012 System 1 – Serial interface module RS-485Product Usage:The System 1 provides perfusion case data transfer through the use of the data transfer module. This module is a general purpose serial interface and is the interface between the TLink Data Management ystem or Sarns CCPro Data Perfusion oftware and the system. The data collected and exported by the data transfer module includes physiological data and device events to record the progress and events during a procedure. Terumo Cardiovascular Systems has received reports of malfunctions involving the loss of data transfer capabilities using the data transfer capabilities using modules on the Terumo Advanced Perfusion System 1. Some reports stated that the odor of smoke was as associated with the failures. The malfunctions occurred during set-up; during cardiopulmonary bypass; and during routine testing of the modu
GE OEC Medical Systems; Inc Aug-22-2012 OEC InstaTrak 3500 – OEC InstaTrak 3500; picture archiving and communications system intended as an aid to locate anatomical structures during open percutaneous surgical procedures. It is indicated for use in medical conditions that may benefit from the use of stereotactic surgical technique. The system provides a reference to rigid anatomical structures such as sinus; skull; long bone; or vertebra; which are visible on medical images such as CT; MRI; or X-ray. GE Healthcare had recalled certain OEC InstaTrak 3500 Carts due to the potential for the cart to tip over when the arm of the imaging device is extended during use.
Stryker Spine Aug-22-2012 Stryker TRIO/TRIO+ – Stryker TRIO+ 4.5 x 45 mm STANDARD POST SCREWStryker TRIO+ 4.5 x 50 mm STANDARD POST SCREWStryker TRIO+ 4.5 x 55 mm STANDARD POST SCREWStryker TRIO+ 5.5 x 45 mm STANDARD POST SCREWStryker TRIO+ 5.5 x 60 mm STANDARD POST SCREWManufactured by: STRYKER Spine SAS; Z.I. Marticot – 33610 – Cestas-France +33 (0)5.57.97.06.30 http://www.stryker.comDistributed in the USA by: Stryker Spine; 2 Pearl Ct.; Allendale; NJ 07401-1677 USA +1-201-750-8000.The Stryker Spine Trio/Trio+ Spinal Fixation Systems are comprised of spinal screws; rods; and connectors. The components are available in a variety of lengths in order to accommodate patient anatomy. The system is intended for posterior; non-cervical pedicle and non-pedicle pedicle fixation of the spine. It is indicated for: degenerative disc disease (DDD); spondylolisthesis; fracture; dislocation; spinal stenosis; scoliosis kyphosis; lordosis; spinal tumor; pseudarthrosis; and failed previous fusion. The front cover of Instructions For Use (IFU) #NOLI135B03Rev02 was improperly marked with a "Sterile" logo in the lower right corner. The products these IFUs were packed with are sold as "Non-Sterile" and require sterilization before use in surgery.
Philips Medical Systems (Cleveland) Inc Aug-22-2012 Brilliance 6; 10; 16; 40; 64 and CT Big Bore – The Brilliance 6; 10; 16; 40; 64 and CT Big Bore are Computed Tomography X-Ray Systems These devices may include signal analysis and display equipment; patient; and equipment supports; components and accessories.Product Usage:The Brilliance 6; 10; 16; 40; 64 and CT Big Bore are Computed Tomography X-Ray Systems that are 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 The patient support may move in an unintended manner if the foot switch cover becomes damaged and impinges on the foot switch.
Siemens Healthcare Diagnostics; Inc. Aug-22-2012 EasyLink(TM) Informatics System included with the Dimension Vista System – EasyLink Informatic System is included with the Dimension Vista System. The Dimension Vista Integrated System is an in vitro diagnostic device intended tot duplicate manual analytical procedures such as pipetting; mixing; heating; and measuring spectral intensities to determine a variety of analytes in human body fluids.The EasyLink Informatics System is classified as a data calculator and processing module for use with in vitro diagnostic devices. The EasyLink is included with the Dimension Vista System and may be used with other Siemens analyzers as a communications and connectivity workstation for integration with laboratory information system (LIS) networks. When using the EasyLink Quality Control Package the system may not perform as intended for Multi-Rule QC violations [e.g.; 2(2S); 4(1s) and 10x]; unless configured using the instructions send with the Urgent Field Safety Notice. When this situation occurs; QC status may not be flagged appropriately. If auto-verification rules are defined to hold patient results when QC status is out; the patient
AGFA Corp. Aug-22-2012 AGFA DICOMStore – AGFA IMPAC CV DICOMStore with Media Purge Daemon (MPD) and IMPAX CV DICOMStore with Cardiovascular Purge Services (CPS); Medical Image Storage Device Loss of patient data can occur under certain circumstances due to misconfiguration of DICOMstore configured with Agfa’s Medical Image Storage Devices – Media Purge Daemon (MPD) and Cardiovascular Purge Service (CPS).
GE OEC Medical Systems; Inc Aug-22-2012 GE HC OEC 9900 Elite and GE OEC 9800 Fluoroscopes – GE HC OEC 9900 Elite and GE OEC 9800 Fluoroscopes Snubber Boards are a PCB with a 70 amp fuse to provide fused protection of internal system components from the high voltage system components; such as the X-ray tube or High Voltage Transformer. System model number A349855; Snubber Board number 00-880405-03 rev 5. This product is used for image intensified fluoroscopic x-rays for interventional radiologic procedures. GE OEC recalled certain 9800 Fluoroscope & 9900 Elite Models because the Snubber Board did not conform to the IEC 60601-1 standard for clearance and creepage of voltage isolation.
Abbott Point Of Care Inc. Aug-22-2012 i-STAT cTnI cartridges – i-STAT cTnI cartridgesProduct Usage:The i-STAT cTnl test is an in vitro diagnostic test for the quantitative measurement of cardiac troponin I in heparinized whole blood or plasma samples. Cardiac I troponin measurement cane be used as an aid in the diagnosis and treatment of myocardial infarction and in the risk stratification of patients with acute coronary syndromes with respect to their relative risk of mortality. Abbott Point of Care has determined that i-Stat CTNL cartridges have the potential to exhibit incorrectly elevated cardiac troponin I results. This recall was expanded on July 19 2012 to include additional information regarding user documentation.
GE OEC Medical Systems; Inc Aug-22-2012 GE OEC 9800 – 892.1650 Image-intensified fluoroscopic x-ray system; the device is designed to provide fluoroscopic and spot film imaging of the patient during diagnostic surgical and interventional procedures. The systems include features specifically designed for use in diagnostic and interventional cardiac imaging procedures; and are also intended for cholangiography; endoscopic; urologic; orthopedic; neurologic; vascular; critical care and emergency room procedures. The systems may be used for other imaging applications at the physician’s discretion. GE OEC is recalling certain 9800 Image Intensified Flouroscopic x-ray systems due to customer complaint analysis showing that a replacement Hitachi 160 GB Hard Drive; when installed on certain models is susceptible of causing unanticipated system shut downs; no boots; data loss or data mix; or unexpected hard drive corruption.
Philips Medical Systems (Cleveland) Inc Aug-22-2012 Positron Emission Tomography (PET) and X-ray Computed Tomography – Positron Emission Tomography (PET) and X-ray Computed Tomography; GEMINI TF 16 PET/CT; GEMINI GXL 16 PET/CT; GEMINI TF Big Bore PET/CT; Philips Medical Systems; Cleveland; OH. The device is a diagnostic imaging system 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. Image processing and display workstations provide software applications to process; analyze; display; quantify and interpret medical images/data. The PET and CT images may be registered and displayed in a "fused" (overlaid in the same spatial orientation) format to provide combined metabolic and anatomical data at different angles. Trained professionals use the images in: " The evaluation; detection and diagnosis of lesions; disease and organ function such as but not limited to cancer; cardiovascular disease; and neurological disorders. " The detection; localization; and staging of tumors and diagnosing cancer patients. " Treatment planning and interventional radiology procedures. The device includes software that provides a quantified analysis of with regional cerebral activity from PET images. Philips became aware of an issue relating to a UPS battery cabinet that appeared to have burned a hole through the casing on one of the batteries. Supplier of the UPS; Chloride/Emerson; determined the batteries; housed within the UPS battery cabinet; entered thermal runaway causing the battery to overheat.
Mckesson Medical Imaging Group Aug-22-2012 Horizon Medical Imaging system. – Horizon Medical Imaging system.Product Usage: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 image systems. The medical modalities of these medical imaging systems include; but are not limited to; all modalities supported by ACR/NEMA DICOM 3.0 (specifically including mammographic images). Horizon Medical Imaging is intended to function with a variety of storage systems and printers via DICOM and other computer industry standard interfaces and protocols. Horizon Medical Imaging is indicated for use by trained medical professionals including; but not limited to; radiologist; physicians; and medical technologists. Horizon Medical Imaging is also indicated for use in soft copy diagnostic interpretation of medical images and video by physicians trained in such practice (specifically including soft copy diagnostic interpretation of mammographic images). There is a potential to save reports in RadReport with an Incorrect Final Status.
Medtronic Navigation; Inc. Aug-22-2012 Medtronic O-arm Imaging System – Medtronic O-arm¿ Imaging System. Product Numbers: BI-700-00027-100; BI-700-00027-100R; BI-700-00027-120; BI-700-00027-120R; BI-700-00027-230; BI-700-00027-230R. A fault in a high voltage relay in the 0-arm? Imaging System might cause the relay to overheat and burn.
Stryker Medical Division of Stryker Corporation Aug-22-2012 Powered Mobility Offers Versatility (M¿V)TM Chair1 – Powered Mobility Offers Versatility (M¿V)TM Chair.The Powered MOV Chair models EMS; EMS24; HHC; and INO Powered MOV Chair; enable two operators to transport a seated patient weighing up to 500 Ibs up or down stairs. Key features include infinite positioning system; thermal protection system; and locking casters. In addition to the aforementioned features; the battery powered track reduces operator effort and risk of back injury while transporting a patient up or down a set of stairs Paramed Corporation (d/b/a; Descent Control Systems); a manufacturer and distributor of patient transport devices; merged with an affiliate of Stryker Corporation in August 2009. As part of the due diligence process; Paramed’s powered Mobility Offers Versatility (M?V) chair was reviewed to identify potential compliance issues in relation to product documentation and classification.
Stryker Medical Division of Stryker Corporation Aug-22-2012 Powered Mobility Offers Versatility (M¿V)TM Chair1 – Powered Mobility Offers Versatility (M¿V)TM ChairThe Powered MOV Chair models EMS; EMS24; HHC; and INO Powered MOV Chair; enable two operators to transport a seated patient weighing up to 500 Ibs up or down stairs. Key features include infinite positioning system; thermal protection system; and locking casters. In addition to the aforementioned features; the battery powered track reduces operator effort and risk of back injury while transporting a patient up or down a set of stairs. Paramed Corporation (d/b/a; Descent Control Systems); a manufacturer and distributor of patient transport devices; merged with an affiliate of Stryker Corporation in August 2009. As part of the due diligence process; Paramed’s powered Mobility Offers Versatility (M?V) chair was reviewed to identify potential compliance issues in relation to product documentation and classification.
Stryker Medical Division of Stryker Corporation Aug-22-2012 Powered Mobility Offers Versatility (M¿V)TM Chair1 – Powered Mobility Offers Versatility (M¿V)TM ChairThe Powered MOV Chair models EMS; EMS24; HHC; and INO Powered MOV Chair; enable two operators to transport a seated patient weighing up to 500 Ibs up or down stairs. Key features include infinite positioning system; thermal protection system; and locking casters. In addition to the aforementioned features; the battery powered track reduces operator effort and risk of back injury while transporting a patient up or down a set of stairs. Paramed Corporation (d/b/a; Descent Control Systems); a manufacturer and distributor of patient transport devices; merged with an affiliate of Stryker Corporation in August 2009. As part of the due diligence process; Paramed’s powered Mobility Offers Versatility (M?V) chair was reviewed to identify potential compliance issues in relation to product documentation and classification.
Stryker Medical Division of Stryker Corporation Aug-22-2012 Powered Mobility Offers Versatility (M¿V)TM Chair1 – Powered Mobility Offers Versatility (M¿V)TM Chair.The Powered MOV Chair models EMS; EMS24; HHC; and INO Powered MOV Chair; enable two operators to transport a seated patient weighing up to 500 Ibs up or down stairs. Key features include infinite positioning system; thermal protection system; and locking casters. In addition to the aforementioned features; the battery powered track reduces operator effort and risk of back injury while transporting a patient up or down a set of stairs. Paramed Corporation (d/b/a; Descent Control Systems); a manufacturer and distributor of patient transport devices; merged with an affiliate of Stryker Corporation in August 2009. As part of the due diligence process; Paramed’s powered Mobility Offers Versatility (M?V) chair was reviewed to identify potential compliance issues in relation to product documentation and classification.
GE OEC Medical Systems; Inc Aug-23-2012 GEHC OEC Injection Cable for MedRad Provis V Contrast Injector. – GEHC OEC Injection Cable for MedRad Provis V Contrast Injector. In certain fluoroscope X-ray modes; the cable provides a signal to the auto-injector to trigger a contrast injection. Part numbers include 00-902260-01 and 00-883654-01. GE initiated a correction to the instructions/use due to the potential for erroneous auto injection of contrast dye.
Galil Medical; Inc. Aug-23-2012 Visual-ICE¿ Cryoablation System – Visual-ICE¿ Cryoablation System; Model FPRCH 6000Product Usage: The Galil Medical Visual-ICE Cryoablation System is intended for cryoablative destruction of tissue during minimally invasive procedures; various Galil Medical accessory products are required to perform these procedures. The Visual-ICE System is indicated for use as a cryosurgical tool in the fields of general surgery; dermatology; neurology (including cryoanalgesia); thoracic surgery; ENT; gynecology; oncology; proctology; and urology. This system is designed to destroy tissue (including prostate and kidney tissue; liver metastases; tumors; skin lesions; and warts) by the application of extremely cold temperatures. Galil Medical is recalling a number of Visual Ice Cryoablation Systems because the gas regulators may fail to regulate the gas pressure; rendering the devices inoperable.
Hitachi Medical Systems America Inc Aug-23-2012 Echelon and Oasis – Hitachi Echelon MRI System/Oasis MRI; Software. These are software controlled MRI devices.Product Usage:The Echelon and Oasis MR systems are imaging devices; intended to provide the physician with physiological and clinical information that can be useful in diagnosis determination. Hitachi discovered a software error with a feature called Multi-Planar Reconstruction(MPR). MPR takes an original volume dataset reconstructed in any plane view and creates a new image set from another view (i.e. axial to coronal; coronal to sagittal; etc.). The error causes the first image in the dataset to have a right/left reversed orientation. The software error can occur randomly when execu
Beckman Coulter Inc. Aug-23-2012 UniCel DxI and DXC Immunoassay Systems – UniCel DxI 600 Access Immunoassay Systems; Part Numbers: Dxl 600: A30260; Dxl 600 with spot B: A71460.The DxI Immunoassay System is an in vitro diagnostic device used for the quantitative; semi-quantitative or qualitative determination of various analyte concentrations found in human body fluids. The recall was initiated because Beckman Coulter has received seven reports of a software anomaly for the UniCel Dxl Immunoassay Systems. If undetected; this anomaly may cause erroneous test results.
Beckman Coulter Inc. Aug-23-2012 UniCel DxI and DXC Immunoassay Systems – UniCel DxI 800 Access Immunoassay Systems; Part Numbers: Dxl 800: 937100; Dxl 800 Remanufactured: A25288;Dxl 800 with spot B: A71456;Dxl 800 Reconditioned: A25285.The DxI Immunoassay System is an in vitro diagnostic device used for the quantitative; semi-quantitative or qualitative determination of various analyte concentrations found in human body fluids. The recall was initiated because Beckman Coulter has received seven reports of a software anomaly for the UniCel Dxl Immunoassay Systems. If undetected; this anomaly may cause erroneous test results.
Beckman Coulter Inc. Aug-23-2012 UniCel DxI and DXC Immunoassay Systems – UniCel DxC 660i; 680i; 860i; 880i SYNCHRON Access Clinical Systems; Part Numbers: DxC 660i: A64871; DxC 680i: A64903;DxC 860i: A64935;DxC 880i: A59102.The DxI Immunoassay System is an in vitro diagnostic device used for the quantitative; semi-quantitative or qualitative determination of various analyte concentrations found in human body fluids. The recall was initiated because Beckman Coulter has received seven reports of a software anomaly for the UniCel Dxl Immunoassay Systems. If undetected; this anomaly may cause erroneous test results.
Siemens Medical Solutions USA; Inc Aug-24-2012 syngo Imaging XS – syngo Imaging XS.Radiological image processing system. There is a potential malfunction when using syngo Imaging XS; version VA70A or higher. In some situations it can happen that a miscalculation is done for the grey scale values in the functions "Regions of Interest"; "Pixel Lens"; "Edge Enhancement" and "Histograms".
Canon Inc. Aug-24-2012 Digital Radiography; CXDI – Canon Solid Stale X-ray Imaqer (Flat Panel/Digital Imager); Digital Radiography; Models CXDI-55C; CXDI-55G and CXDI-70C. These devices are intended to replace radiographic film/screen systems in all general purpose diagnostic procedures. Screws holding the 55REF circuit board are loosening and roaming inside of the sealed sensor.
Cisco Systems Inc Aug-24-2012 Cisco – Cisco brand HealthPresence; version 2.1; Model/Catalog Number: CHP-ENTPRSYR2.I-K9; Product is manufactured and distributed by Cisco Systems; Inc. San Jose; CACisco HealthPresence; version 2 is intended for remote consultation of patients with a healthcare provider. Cisco HealthPresence enables remote collaboration between a physician and a patient by providing: high-definition video and advanced audio; transmission and display of third-party medical device data; integration with third party EMR: scheduling: and other software applications for remote consultations and exams. Cisco Health Presence is not intended for use in emergency situations. Cisco HealthPresence is not intended for use in active patient monitoring or alarming. Software anomaly may result in incorrect values and interpretations. The initial vital signs reading will display accurately on the Cisco Health Presence Vitals tab and the OnePlace tab. However; subsequent vital signs readings will only update on the Cisco HealthPresence Vitals tab and within the OnePlace database; but will not update under the OnePlace tab; and thus; will not provide current vit
Sunquest Information Systems; Inc. Aug-24-2012 Sunquest Laboratory LabAccess Results Workstation – Sunquest Laboratory LabAccess Results Workstation (LARS) The recall was initiated because Sunquest has confirmed that the Sunquest Laboratory LabAccess Results Workstation (LARS) may file results to the wrong patient by incorrectly combining results.
Biomet 3i; LLC Aug-24-2012 Low Profile Abutment – Low Profile Abutment; Non-Hexed Castable Cylinder Model LPCCC1. Product is labeled in part: "***REF LPCCC1***Low profile Abutment Hexed Castable Cylinder***Cylinder; Cylindre; Zylinder; Cilindro; Cilindro; Cilindro***RX only***NON STERILE***Caution: Law prohibits dispensing without prescription***Consult instructions for use***Castable cylinders are intended to be used to produce a definitive casting for dental restoration onto which porcelain can then be cast. Biomet 3i conducted a recall on the device Low Profile Abutment; Non-Hexed Castable Cylinder due to some packages labeled LPCCC1; Hexed Castable Cylinder possibly containing LPCCC2; Non-Hexed Castable Cylinders.
Metrex Research; LLC. Aug-24-2012 CaviCide – CaviCide; Part Numbers: 13-1025; 13-1000; 13-1024; MC-1000.Alternate brands:EnviroCide; part number: 13-3325.Private labeled products of Cavicide:Backscratchers Cavicide; part number: 13-4800.MaxiSpray Plus; part numbers: 13-7400 and 13-7405.pdCARE Surface Disinfectant; part numbers: 13-7525 and 13-7500.Z3 Surface Disinfectant; part number: 13-7900.CaviCide is a multi-purpose disinfectant/decontaminant cleaner for use on hard; non-porous inanimate surfaces. CaviCide is a bactericidal; virucidal; fungicidal; and tuberulocidal which is available in a ready-to-use; liquid form typically contained in 1 gallon bottles; 2.5 gallon bottles; 25 oz. spray bottles; or 55 gallon drums (depending on the item number). CaviCide may also be branded as a private label (see (1)(vi) below for names and Table 1 above for additional details). The product may be used (1) for precleaning non-instrument surfaces prior to disinfection; (2) for precleaning instruments prior to disinfection; (3) as a virucide on non-instrument surfaces; (4) as a disinfectant on non-instrument surfaces; (5) as a virucide on precleaned non-critical medical devices; instruments and implements; and (6) as a disinfectant on precleaned non-critical medical devices; instruments; and instruments. It is useful in health care settings such as hospitals; emergency medical settings; surgical centers; isolation areas; neonatal units; patient care areas; ophthalmic and optometric facilities; dental offices; dental operatories; animal care facilities; salon settings; emergency vehicles; schools; health club facilities; kitchens; bathrooms; prisons; morgues; and other critical care areas. Metrex Research is recalling Cavicide containing the Spring Fresh Fragrance because the affected lot of product containing this fragance has caused an increase in reported health reactions in some individuals such as headache; nausea; and respiratory discomfort.
Sunquest Information Systems; Inc. Aug-24-2012 Sunquest Laboratory Versions 6.4 – Sunquest Laboratory Versions 6.4 and later using Microbiology Result Entry The recall was initiated because Sunquest has confirmed that the Sunquest Laboratory versions 6.4 and later while using Microbiology Result Entry (MRE); the specimen ribbon containing the Accession Number (AN) and the Battery Name may be missing or contain the wrong information.
Toshiba American Medical Systems Inc Aug-24-2012 Scanner; Computed Tomography; X-Ray – Toshiba CT systems; Asteion and Aquilion; that are equipped with a PC based computer; or to those older systems (SGI based) that received an improved table by an upgrade purchase. This device is designed to produce cross-sectional images of a human body by reconstruction of xray transmission data from the same axial plane taken at different angles. These images have been proven to be clinically useful in the diagnosis of spine and head injuries; intracranial tumors; blood clots in the brain; eye trauma; soft tissue lesions in the extremities; gastrointestinal lesions; abdominal and pelvic malignancies; and hepatic metastases. CT is also used to evaluate intestinal obstruction!;; assess intra-abdominal abnormalities and to examine musculoskeletal degeneration. This device employs no intended uses that are not in cleared devices already found in the marketplace. The systems all have a similar table control board. It hasbeen found that this board may cause the table position to be incorrect if the table cradle is movedmanually. This is referred to as "Free" mode in the operation manuals. If this error does occur it ispossible that the patient could be scanned at an incorrect position.
Siemens Medical Solutions USA; Inc Aug-27-2012 syngo.plaza – syngo.plaza; Model number 10592457.Intended use: radiological image processing system. There is a potential malfunction in which a miscalculation occurs for images with pixel depth values greater that 12 bit in certain functions.
Advanced Sterilization Products Aug-27-2012 CIDEX OPA – CIDEX OPA; High Level Disinfectant Solution; Glutaraldehyde-free (0.55% ortho-phthaladehyde) solution. The CIDEX OPA solution is intended for automated and manual cleaning and disinfection. The recall was initiated because Advanced Sterilization Products has discovered instances of missing labels on bottles of CIDEX OPA Solution; Part # 20390 manufactured between May 2011 and April 2012.
Atlas Spine; Inc. Aug-27-2012 Apelo Modular Screwdriver for Apelo Pedicle Screw System – Apelo Modular Screwdriver labeled in part: "APELO PEDICLE SCREW SYSTEM***Modular Screwdriver***Atlas Spine; Inc.***www.AtlasSpine.com*** 1555 Jupiter Park Drive #4***Jupiter; Florida 33458***561-741-1108***Tissue Sleeve***MFG Date: XX/XX/XXXX***Lot #: XXXX***Weldment***MFG Date: 03/23/2009***Sleeve Assembly***MFG Date: XX/XX/XXXX***Lot #: XXXX***Qty: 1 Rx Only***Non-Sterile. Sterilize Prior to Use*** Rev. A***. The Modular Screwdriver is used to insert modular pedicle screw implants which are part of the Apelo System. Atlas Spine; Inc. recalled their Apelo Modular Screwdriver; a component of the Apelo Pedicle Screw System Instrumentation; because of complaints received about the tip breaking. If the tip is fractured inside of the modular screw; the tip could become implanted in the body or if the entire screw is removed; it could cause a delay in the surgery.
Alphatec Spine; Inc. Aug-27-2012 TRESTLE LUXE¿ Anterior Cervical Plating System – TRESTLE LUXE¿ Anterior Cervical Plating System; Product code KWQ. 510(k) K102820.The TRESTLE LUXE Anterior Cervical Plating System is a temporary device used to stabilize the cervical spine during bone fusion development. Device implants include a range of plate sizes and bone screws to provide the versatility required for the specific indications noted. Fixation is achieved by means of a rigid plate that is surgically attached to the spine with bone screws. The TRESTLE LUXE Anterior Cervical Plating System is intended for use in the anterior cervical spine (C2-C7). Patients with trauma (including fractures); spondylolisthesis; and pseudoarthrosis; degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spinal stenosis; tumors; and failed previous fusion. On May 9th 2012 Alphatec Spine received a complaint which reported that the distal tipof the Trestle Luxe Slide Alignment Tool (Part Number 71721); does not properly fit intothe hexalobe screw on the Trestle Luxe Plate.
Toshiba American Medical Systems Inc Aug-28-2012 EXCELART Vantage; Atlas; and Titan MRl Systems MRT.1503 and MRT-1504 – EXCELART Vantage; Atlas; and Titan MRI Systems; MRT-1503 and MRT-1504.Imaging of the Whole Body; Fluid Visualization; 2D/3D Imaging; MR Angiography/MR Vascular Imaging; Blood Oxygenation Level Dependent Imaging; Perfusion I Diffusion Imaging; and Proton Spectroscopy. The status display in the sequence queue window may not change from "Current" to "Done".
Steris Corporation Aug-28-2012 QKC1692E – QKC1692E The QKC1692E Quick Connect device connects endoscopes to the sterilization tray for C1220E liquid chemical sterilization processor. STERIS has been actively seeking devices for quick connect revalidation projects. STERIS was unable to obtain two (2) of the needed devices; these two devices represent the design of seven (7) models in one quick connect. Due to the unavailability of these two validation devices; STERIS will remove 7 models from the labeling of QKC1692E and will re-label all QKC1692Es in the field..
Toshiba American Medical Systems Inc Aug-28-2012 Aquilion One CT System; TSX-301A/2 – Whole Body X–ray ScannerThis device is indicated as a whole body volume CT system. The system produces volumes of up to 320 axial slices in a single rotation. 1. It has been found that in raw data processing for Go&Return helical scanning; when the raw data acquired in the first scan (Go) and that acquired in the second scan (Return) are selected and reconstructed at one time; incorrect couch positions and scan times are displayed on the reconstructed images for the data acquired by Return scanning; while all related information is displayed on the reco
Mindray DS USA; Inc. d.b.a. Mindray North America Aug-28-2012 V Series Monitor – V Series Patient Monitors; Mindray DS USA; Inc.Product Usage:The V Series Monitor is intended for intra hospital use under the direct supervision of a licensed healthcare practitioner. The indications for Use for the V Series include the monitoring of the following human physiological parameters: ECG waveform derived from 3; 5; 6 and 12 lead measurements; Heart Rate; Pulse Oximetry (SpO2); ST Segment Analysis; Arrhythmia Detection; Non Invasive Blood Pressure (NIBP); Invasive Blood Pressure (IBP); Cardiac Output (CO); Respiratory Gasses; Respiration Rate; and Temperature. The V Series Monitor has the capability of performing IV Drug and Hemodynamic Calculations and interfacing with network devices. The target populations are adult; pediatric and neonate with the exception of: Arrhythmia detection and ST Segment Analysis; for which the target populations are adult and pediatric only; IV Drug Calculations for which the target population is adult only; and Cardiac Output for which the target population is adult and pediatric only. Mindray has identified two software anomalies contained in the V Series Monitoring System. There have been no reports of injuries associated with these anomalies. These anomalies affect V Series Systems distributed between September 31; 2010 and January 9; 2012.
Advanced Neuromodulation Systems Inc. Aug-28-2012 Eon – Eon (Model 3716) IPG is a dual channel; 8-contact receiver designed to be connected to 4; 8; or 16 electrode leads or a lead extension. Product Usage:The Eon and Eon Mini Neurostimulation Systems are indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs including unilateral or bilateral pain associated with the following: failed back surgery syndrome; intractable low back and leg pain. As of 11/30/2011; St. Jude Medical has received 110 patient complaints of warmth or heating at the implantable pulse generators (IPGs) implant site during charging for the Eon IPG and 116 reports of similar symptoms for the Eon Mini IPG; respectively.
Advanced Neuromodulation Systems Inc. Aug-28-2012 Eon Mini – The Eon Mini Neurostimulation (IPG) System (Model 3788) is a 16-channel; rechargeable; multi-program system that allows the connection of one or two leads with 4; 8; and 16 electrode leads.Product Usage:The Eon and Eon Mini Neurostimulation Systems are indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs including unilateral or bilateral pain associated with the following: failed back surgery syndrome; intractable low back and leg pain. As of 11/30/2011; St. Jude Medical has received 110 patient complaints of warmth or heating at the implantable pulse generators (IPGs) implant site during charging for the Eon IPG and 116 reports of similar symptoms for the Eon Mini IPG; respectively.
Unimed Surgical Products; Inc. Aug-28-2012 Mediline Industries; Inc. – Product is labeled in part: "***MEDLINE***Extended PTFE Coated Blade with Extended Insulation 6.5 (16.51cm) Length***Reorder: ES0014M***Contents: 1 Each***SINGLE USE ONLY**latexfree***RX Only***STERILE EO***www.medline.com Manufactured for Medline Industries; Inc. MEDLINE is a registered trademark of Medline Industries; Inc. 1-800-MEDLINE***Mundelein; IL 60060 USA Made in USA.***" Part # ES0014M– Lot # 050609-05; 052909-05; 062309-04.Product Usage: Intended for cutting and coagulation of soft tissue. On 6/16/2010 Unimed Surgical Products; Inc.; 10401 Belcher Road; Largo; FL 33777 initiated a recall of the Medline Industries; Inc. Electrosurgical electrodes used for cutting and coagulation of soft tissue due to concerns of sterility.
Unimed Surgical Products; Inc. Aug-28-2012 Mediline Industries; Inc. – Product is labeled in part: "***MEDLINE***Extended 5mm PTFE Coated Ball 5.0 (12.70cm) Length***Reorder: ES0009***Contents: 1 Each***SINGLE USE ONLY**latexfree***RX Only***STERILE EO***www.medline.com Manufactured for Medline Industries; Inc. MEDLINE is a registered trademark of Medline Industries; Inc. 1-800-MEDLINE***Mundelein; IL 60060 USA Made in USA.***" Part # ES0009 — Lot # 052709-01Product Usage: Intended for cutting and coagulation of soft tissue. On 6/16/2010 Unimed Surgical Products; Inc.; 10401 Belcher Road; Largo; FL 33777 initiated a recall of the Medline Industries; Inc. Electrosurgical electrodes used for cutting and coagulation of soft tissue due to concerns of sterility.
Unimed Surgical Products; Inc. Aug-28-2012 Mediline Industries; Inc. – Product is labeled in part: "***MEDLINE***Extended PTFE Coated Blade with Extended Insulation 4.0 (10.16cm) Length***Reorder: ES0014AM***Contents: 1 Each***SINGLE USE ONLY**latexfree***RX Only***STERILE EO***www.medline.com Manufactured for Medline Industries; Inc. MEDLINE is a registered trademark of Medline Industries; Inc. 1-800-MEDLINE***Mundelein; IL 60060 USA Made in USA.***" Part # ES0014AM — Lot # 050409-05; 050609-05.Product Usage: Intended for cutting and coagulation of soft tissue. On 6/16/2010 Unimed Surgical Products; Inc.; 10401 Belcher Road; Largo; FL 33777 initiated a recall of the Medline Industries; Inc. Electrosurgical electrodes used for cutting and coagulation of soft tissue due to concerns of sterility.
Unimed Surgical Products; Inc. Aug-28-2012 Mediline Industries; Inc. – Product is labeled in part: "***MEDLINE***Extended PTFE Coated Blade 6.5 (16.51cm) Length***Reorder: ES0014***Contents: 1 Each***SINGLE USE ONLY**latexfree***RX Only***STERILE EO***www.medline.com Manufactured for Medline Industries; Inc. MEDLINE is a registered trademark of Medline Industries; Inc. 1-800-MEDLINE***Mundelein; IL 60060 USA Made in USA.***" Part # ES0014 — Lot # 042209-03.Product Usage: Intended for cutting and coagulation of soft tissue. On 6/16/2010 Unimed Surgical Products; Inc.; 10401 Belcher Road; Largo; FL 33777 initiated a recall of the Medline Industries; Inc. Electrosurgical electrodes used for cutting and coagulation of soft tissue due to concerns of sterility.
Unimed Surgical Products; Inc. Aug-28-2012 Mediline Industries; Inc. – Product is labeled in part: "***MEDLINE***Standard PTFE Coated Needle with Extended Insulation 2.75 (6.99cm) Length***Reorder: ES0013M***Contents: 1 Each***SINGLE USE ONLY**latexfree***RX Only***STERILE EO***www.medline.com Manufactured for Medline Industries; Inc. MEDLINE is a registered trademark of Medline Industries; Inc. 1-800-MEDLINE***Mundelein; IL 60060 USA Made in USA.***" Part # ES0013M — Lot # 042209-02 Product Usage: Intended for cutting and coagulation of soft tissue. On 6/16/2010 Unimed Surgical Products; Inc.; 10401 Belcher Road; Largo; FL 33777 initiated a recall of the Medline Industries; Inc. Electrosurgical electrodes used for cutting and coagulation of soft tissue due to concerns of sterility.
Unimed Surgical Products; Inc. Aug-28-2012 Mediline Industries; Inc. – Product is labeled in part: "***MEDLINE***Staight Microsurgical Needle 3cm (1.81) Length***Reorder: ESE1651***Contents: 1 Each***SINGLE USE ONLY**latexfree***RX Only***STERILE EO***www.medline.com Manufactured for Medline Industries; Inc. MEDLINE is a registered trademark of Medline Industries; Inc. 1-800-MEDLINE***Mundelein; IL 60060 USA Made in USA.***" Part # ESE1651 — Lot # 03059-03Product Usage: Intended for cutting and coagulation of soft tissue. On 6/16/2010 Unimed Surgical Products; Inc.; 10401 Belcher Road; Largo; FL 33777 initiated a recall of the Medline Industries; Inc. Electrosurgical electrodes used for cutting and coagulation of soft tissue due to concerns of sterility.
Unimed Surgical Products; Inc. Aug-28-2012 Mediline Industries; Inc. – Product is labeled in part: "***MEDLINE***Standard PTFE Coated Needle 2.75" (6.99cm) Length***Reorder: ES0013***Contents: 1 Each***SINGLE USE ONLY**latexfree***RX Only***STERILE EO***www.medline.com Manufactured for Medline Industries; Inc. MEDLINE is a registered trademark of Medline Industries; Inc. 1-800-MEDLINE***Mundelein; IL 60060 USA Made in USA.***" Part # ES0013 — Lot # 030309-02 and 030509-05Product Usage: Intended for cutting and coagulation of soft tissue. On 6/16/2010 Unimed Surgical Products; Inc.; 10401 Belcher Road; Largo; FL 33777 initiated a recall of the Medline Industries; Inc. Electrosurgical electrodes used for cutting and coagulation of soft tissue due to concerns of sterility.
Unimed Surgical Products; Inc. Aug-28-2012 Mediline Industries; Inc. – Product is labeled in part: "***MEDLINE***Extended PTFE Coated Needle with Extended Insulation 4.0" (10.16cm) Length***Reorder: ES0016AM***Contents: 1 Each***SINGLE USE ONLY**latexfree***RX Only***STERILE EO***www.medline.com Manufactured for Medline Industries; Inc. MEDLINE is a registered trademark of Medline Industries; Inc. 1-800-MEDLINE***Mundelein; IL 60060 USA Made in USA.***" Part # ES0016AM — Lot #: 062408-08; 062509-01.Product Usage: Intended for cutting and coagulation of soft tissue. On 6/16/2010 Unimed Surgical Products; Inc.; 10401 Belcher Road; Largo; FL 33777 initiated a recall of the Medline Industries; Inc. Electrosurgical electrodes used for cutting and coagulation of soft tissue due to concerns of sterility.
Unimed Surgical Products; Inc. Aug-28-2012 Mediline Industries; Inc. – Product is labeled in part: "***MEDLINE***Extended PTFE Coated Needle 4.0" (10.16cm) Length***Reorder: ES0016A***Contents: 1 Each***SINGLE USE ONLY**latexfree***RX Only***STERILE EO***www.medline.com Manufactured for Medline Industries; Inc. MEDLINE is a registered trademark of Medline Industries; Inc. 1-800-MEDLINE***Mundelein; IL 60060 USA Made in USA.***" Part # ES0016A — Lot #: 121808-20.Product Usage: Intended for cutting and coagulation of soft tissue. On 6/16/2010 Unimed Surgical Products; Inc.; 10401 Belcher Road; Largo; FL 33777 initiated a recall of the Medline Industries; Inc. Electrosurgical electrodes used for cutting and coagulation of soft tissue due to concerns of sterility.
Unimed Surgical Products; Inc. Aug-28-2012 Mediline Industries; Inc. – Product is labeled in part: "***MEDLINE***Extended PTFE Needle 6.5" (16.51cm) Length***Reorder: ES0016***Contents: 1 Each***SINGLE USE ONLY**latexfree***RX Only***STERILE EO***www.medline.com Manufactured for Medline Industries; Inc. MEDLINE is a registered trademark of Medline Industries; Inc. 1-800-MEDLINE***Mundelein; IL 60060 USA Made in USA.***" Part # ES0016 — Lot #: 030608-01 and 121808-19.Product Usage: Intended for cutting and coagulation of soft tissue. On 6/16/2010 Unimed Surgical Products; Inc.; 10401 Belcher Road; Largo; FL 33777 initiated a recall of the Medline Industries; Inc. Electrosurgical electrodes used for cutting and coagulation of soft tissue due to concerns of sterility.
Unimed Surgical Products; Inc. Aug-28-2012 Mediline Industries; Inc. – Product is labeled in part: "***MEDLINE***Standard PTFE Coated Blade with Extended Insulation 2.50 (6.40cm) Length***Reorder: ES0012M***Contents: 1 Each***SINGLE USE ONLY**latexfree***RX Only***STERILE EO***www.medline.com Manufactured for Medline Industries; Inc. MEDLINE is a registered trademark of Medline Industries; Inc. 1-800-MEDLINE***Mundelein; IL 60060 USA Made in USA.***" Part # ES0012M — Lot # 030509-07; 052909-02; 062309-02. Product Usage: Intended for cutting and coagulation of soft tissue. On 6/16/2010 Unimed Surgical Products; Inc.; 10401 Belcher Road; Largo; FL 33777 initiated a recall of the Medline Industries; Inc. Electrosurgical electrodes used for cutting and coagulation of soft tissue due to concerns of sterility.
Nellcor Puritan Bennett Inc. (dba Covidien LP) Aug-29-2012 Cool-tip RFA Electrode Kits – DGPHP RFA High-Power Single Use Grounding Pads and Cool-Tip RFA Electrode Kits (containing DGPHP RFA High-Power single use grounding pads)The product is used during ablation surgical procedures. Covidien is conducting a recall of various production lots of DGHP RFA High Power single use grounding pads and Cool-tip RFA Electrode Kits due to the potential for foil degradation on the DGP-HP single use grounding pad which may result in an electrical burn to the patient at the application site.
SRI Surgical Aug-29-2012 Various SRI Surgical Disposable Accessory Packs. – Various SRI Surgical Disposable Accessory Packs.SRI’s Disposable Accessory Packs (also commonly known as convenience kits and custom procedure trays) are an assembly of medical devices packaged together according to the customer specifications; which are then wrapped in a sterilization wrap and sterilized. This allows the customer to open one package for a surgical procedure instead of many individual packages. Distribution of a product that did not meet specifications. (labeling error)
Philips Healthcare Inc. Aug-30-2012 "Philips Healthcare SureSigns VSi/VS2+ – Philips SureSigns VSi/VS2+ patient monitors Model Part NumbersVSi/ 863275; 863276; 863277; VS2+ 863278; 863279.The SureSigns VS2+ vital signs monitor is for monitoring; recording and alarming of multiple physiological parameters of adults; pediatrics; and neonates in healthcare environments. Additionally; the monitor is intended for use in transport situations within a healthcare facility. The SureSigns VSi vital signs monitor is for measurement of multiple physiological parameters of adults; pediatrics; and neonates in healthcare environments. Additionally; the monitor is intended for use in transport situations within a healthcare facility" Philips SureSigns VSi/VS2+ patient monitors may not be properly secured and may fall from the wall mount
Encore Medical; Lp Aug-30-2012 3DKnee e+ Tibial Insert – 3DKnee e+ Tibial Insert – HXLPE-VE; Sterile; Material: Highly cross linked vitamin E PE; Sz 2/9mm.The insert is intended to more closely match the kinematics of the knee; allowing some rotation along the medial condyle and increased congruency along lateral condyle. This insert is to be used along with the other components that comprise the 3DKnee System. The firm is recalling one lot of 392-09-706; 3DKnee e+ Tibial insert; 9 mm; Size 6; Right. The shelf life labeling of specific lots for a component were found to be incorrect and were found to be expired.
Sendx Medical Inc Aug-30-2012 pH Blood Gas and Electrolytes Analyzer System – ABL80 FLEX (with FLEX software) and ABL80 FLEX CO-OX (with CO-OX software) – pH Blood Gas and Electrolytes Analyzer System.Intended Use The ABL80 FLEX (with FLEX software) and ABL80 FLEX CO-OX (with CO-OX software) are portable; automated analyzers that measure pH; blood gases; electrolytes; glucose and oximetry (ABL80 FLEX CO-OX only) in whole blood. The ABL80 FLEX (with FLEX software) and ABL80 FLEX CO-OX (with CO-OX software) analyzer systems are intended for use by trained technologists; nurses; physicians and therapists. They are intended for use in a laboratory environment; near patient or point-of-care setting. The firm recalled because the glucose measurements from a patient sample that the customer felt was too low and did not reflect the patient’s clinical condition.