Class I recalls
Recalling Manufacturer, Date Posted, Trade Name/Product, Reason for Recall
H & H Associates Oct-01-2013 H&H Emergency Cricothyrotomy Kit – H&H Emergency Cricothyrotomy Kit (Part No. HHECT01/ HHECTK01; NSN 6515-01-573-0692); vacuum sealed and packaged in a 5 mil poly bags; labeled in part ***H & H Associates; Inc. CAGE 1NNH6 www.gohandh.com Ordinary; VA 23131 (800) 326-5708***. The product is used to maintain fracture alignment. Medical device tubing used for endotracheal airway application may become weakened and rendered ineffective.
Draeger Medical; Inc. Oct-10-2013 Draeger Fabius – Draeger Fabius GS Premium; Fabius OS; Fabius Tiro; Fabius Tiro D-Mused to administer anesthesia and ventilation to patients during surgical procedures. During final testing of the Draeger Fabius GS Premium; Fabius OS; and Fabius Tiro anesthesia machines; some units did not pass the high voltage test and the minimum clearance between an electrical component and the unit housing was not maintained for some from a specific batch.
Bard Peripheral Vascular Inc Oct-10-2013 LifeStent Solo Vascular Stent – Bard LifeStent Solo Vascular Stent; Item Numbers: EX062001CL; EX072001CL; EX062003CL; EX072003CL.The LifeStent Solo Vascular Stent System is intended to improve luminal diameter in the treatment of symptomatic de-novo or restenotic lesions up to 240 mm in length in the native superficial femoral artery (SFA) and in the proximal popliteal artery with reference vessel diameters ranging from 4.0 6.5 mm. Bard Peripheral Vascular is recalling specific lots of Bard Lifestent Solo Vascular Stent because they have determined a higher incidence rate of partial stent deployment associated with their use.
GE Healthcare; LLC Oct-15-2013 GE Healthcare; Aisys; Amingo; Avance; and Avance CS2 – GE Healthcare; Aisys; Amingo; Avance; and Avance CS2.Intended for volume or pressure control ventilation. GE Healthcare has recently become aware of a potential safety issue involving the Avance; Avance CS2; and Aisys anesthesia devices.While operating in Pressure Control Ventilation Volume Guarantee (PCV-VG) mode; the affected products may produce an over delivery tidal volume when given a unique sequence of user inputs and a collapsed bellows (partially filled circuit).Exposure to excessiv
GE Healthcare; LLC Oct-15-2013 GE Healthcare; Avance; Avance CS2; Aisys; Aespire View; and Engstrom – GE Healthcare; Avance; Avance CS2; Aisys; Aespire View; and Engstrom.Intended for volume or pressure control ventilation. GE Healthcare has recently become aware of a potential safety issue involving unresponsive buttons on the display of the Engstr?m ventilator and the Aespire View; Aisys; and Avance anesthesia machines.As a result of a manufacturing issue; the buttons on the left; right; and bottom keypads may not always detect button presses. This may result in the inability to access certain menu functions wh
Pentax Medical Company Oct-28-2013 PENTAX Endoscopic Accessories – PENTAX Endoscopic Accessories. OF-B194. Made in Japan.PENTAX Upper/Lower G.I. Endoscopes are provided with Air/Water Valve. As an alternative; the optionally available Gas/Water Valve may be used in place of the standard Air/Water Valve to deliver a non-explosive gas for insufflation. PENTAX Medical has become aware of a product issue associated with the OF-B194 Gas/Water Feeding Valve. A manufacturing defect may cause improper stoppage of CO2 gas during an endoscopic procedure with the potential for serious hazard to and/or user.
Atossa Genetics; Inc. Oct-28-2013 ForeCYTE Breast Health Test and the Mammary Aspiration Specimen Cytology Test (MASCT) – Brand: The ForeCYTE Breast Health Test; Mammary Aspiration Specimen Cytology Test (MASCT); MASCT System Kits; Clarity System Kits; MASCT Patient Sample Kits & Clarity Patient Sample Kits Instrument; Biopsy.The MASCT System Kit; Patient Sample Kits; or the Nipple Aspirate Fluid Laboratory Kit has the following codes:PRODUCT CODE: AG-MASCT; AG-FC5; DTG-MASCT; DTG-FC5; and NRLBH-5.PART NUMBER: 9002513; 9002513MD; 9002528; 9002528MD; 9002587; 9002614; and 9002717MD.THE MASCT SYSTEM KIT CONSISTS OF:1. MASCT Breast Pump;2. Instructions for Use (IFU);3. Heating Pad;4. Timer;5. Saccomono’s Fixative;6. Nu Prep Gel;7. Welcome and Training Materials Coversheet;8. MASCT System Order Form;9. ForeCYTE Training Video DVD;10. MASCT System Instructions with pictures – pink;THE PATIENT SAMPLE KIT CONSISTS OF:1. Two (2) flower assemblies (e.g.; filter; filter retainer; and filter holder);2. Instructions for Use (IFU);3. Two (2) specimen collection devices;4. Two (2) breast bags for transporting the specimen collection container;5. Barcode labels;6. Saccomono’s Fixative;7. Nu Prep Gel;8. MASCT System package insert;9. ForeCYTE Test Requisition Form;10. Patient Information Sheet;11. Atossa Patient Information;12. FED EX Clinical PAK;13. MASCT System Order Form;14. FED EX Pouch;15. FED EX Airbill;Product Usage: The MASCT Device is intended for use in the collection of nipple aspirate fluid for cytological testing. The collected fluid can be used in the determination and/or differentiation of normal versus premalignant versus malignant cells. Atossa Genetics is recalling ForeCYTE Breast Health Test; Mammary Aspiration Specimen Cytology Test (MASCT) due concerns raised by the U.S. Food and Drug Administration (FDA) in a warning letter received by Atossa in February 2013. The FDA raised concerns about (1) the current Instructions for Use (IFU); (2) certain promotional claims used to market these devices; and (3) the need for FDA clear
Class II recalls
Recalling Manufacturer, Date Posted, Trade Name/Product, Reason for Recall
Maquet Cardiovascular; LLC Oct-01-2013 ULTIMA OPCAB System – Ultima OPCAB System; Sterile; Rx Only; Product Usage:Intended for use during performance of minimally invasive cardiac surgery through a sternotomy incision approach. The ULTIMA Access RailPlatform in combination with the Activator II Drive Mechanism is used to spread the sternum; providing access and direct visualization to the thoracic cavity. The AccessRail Platform also allows for the organization of pericardial sutures. The ULTIMA Stablizer isolates and provides local immobilization of the target vessel on the beating heart. MAQUET has identified a potential issue with the ULTIMA OPCAB (part numbers OM-2003S & OM-2001D). Labeling for the 2 blade lots had been incorrectly applied. The standard blades from Lot #25052176 were incorrectly labeled as deep blades; and the 20 deep blades from Lot #25052200 were incorrectly labeled as standard blades.
PhotoMedex; Inc. Oct-01-2013 Surgical Laser Technologies; Inc. (SLT) SSRH – The product is labeled in part "***Surgical Laser Technologies; Inc. Montgomeryville; PA***SLT Fiber Delivery System***Sterile***Non-Pyrogenic***. The product is packaged in a flexible pouch and includes the following laser surgery accessories – SLT-SSRH 8; Catalog/Product Number 0041-3082; SLT-SSRH 11; Catalog/Product Number 0041-3112; SLT-SSRH 4-SMA; Catalog/Product Number 0042-0075; SLT-SSRH 5-SMA; Catalog/Product Number 0042-0076; SLT-SSRH 6-SMA; Catalog/Product Number 0042-0077; SLT-SSRH 7-SMA; Catalog/Product Number 0042-0078; SLT-SSRH 8-SMA; Catalog/Product Number 0042-0079; SLT-SSRH 9-SMA; Catalog/Product Number 0041-4931; and SLT-SSRH 10-SMA; Catalog/Product Number 0042-0081.Indicated for the incision; excision; coagulations; and vaporization of soft tissue. Firm became aware that some products within the specified lot may not have been sealed appropriately; thus compromising the sterile barrier.
DeVilbiss Healthcare LLC Oct-01-2013 DeVilbiss Healthcare – DeVilbiss Vacu-Aide QSU Suction Unit (Disposable Suction Container/Filter); 800 ML DISP Container; Unassembled; 800 ML DISP Container w/6′ patient tubing; and 800 ML DISP Container w/6′ patient tubing; assembled.DeVilbiss Vacu-Aide QSU Suction Unit (Disposable Suction Container/Filter) is used to remove fluids from the airway or respiratory support system and infectious materials from wounds. It is available for use by consumers by physician order. End users of the DeVilbiss Disposable Suction Container/Filter had exposed the bacterial filter cartridge to fluid; thereby occluding the filter and rendering it unusable.
Cordis Corporation Oct-01-2013 Cordis ADROIT 6F Guiding Catheter – Cordis ADROIT 6F Guiding CatheterProduct Usage:For intravascular introduction of interventional and/or diagnostic devices into the coronary or peripheral vascular system. Due to a labeling error related to the conversion of the inner diameter of the catheter from inches to millimeters. The English dimension is correct and is the primary dimension.
ASO; LLC Oct-01-2013 SHOPKO Waterproof Adhesive Pads Antibacterial – SHOPKO Waterproof Adhesive Pads Antibacterial.Used for covering minor cuts; scrapes and burns. No antibacterial bandages were packed in boxes labeled as antibacterial.
King Systems Corp. Oct-01-2013 King LTS-D – King LTS-D Oropharyngeal AirwaysProduct Usage: The King LTS-D is intended for use in adult patients (in excess of 25 kg) for controlled ventilation during anesthesia for procedures that are short in duration and when the patient is considered to have a low risk of aspiration of stomach contents. On December 13; 2012; King Systems initiated a voluntary recall of one (1) case(s) (5) individual products) from one (1) lot [(IV1V3) 62 cases; 310 products]of King LTSD Oropharyngeal Airways because the package label indicated that the airway was a size 5 when in fact the airway in the package was a size 4. When King manufacturers a lot; all of the components are the same size; part number etc. I
Philips Medical Systems (Cleveland) Inc Oct-17-2013 Philips – Brilliance CT Big Bore Oncology; Brilliance CT Big Bore Radiology and Brilliance CT 16 (Air)Brilliance CT Big Bore Oncology; Brilliance CT Big Bore Radiology and Brilliance CT 16 (Air) scanners are whole body 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. There are artifacts appearing on the Tracker images during threshold-triggered bolus scans with protocols using a Rotation Time of 0.4 seconds.
GE Healthcare; LLC Oct-17-2013 GE Healthcare; Advantx; Innova 2000; Innova 2100IQ; Innova 3100; Innova 3100IQ; Innova 4100; Innova – GE Healthcare; Advantx; Innova 2000; Innova 2100IQ; Innova 3100; Innova 3100IQ; Innova 4100; Innova 4100IQ.Intended for general purpose diagnostic fluoroscopy and radiography studies. GE Healthcare has become aware of a potential safety issue involving missing screws in the overhead Video Monitor Suspension of the Advantx; Innova 2000; Innova 2100IQ; Innova 3100; Innova 3100IQ; Innova 4100; Innova 4100IQ Cardiovascular X-ray imaging systems.
Sekisui Diagnostics LLC Oct-17-2013 OSOM C. Difficile Toxin A/B Test – Product Name: OSOM C. Difficile Toxin A/B TestCatalog Numbers: 173 (for United States) and 173 E (for Europe).The Test is a qualitative assay (in vitro diagnostic) that employsimmunochromatographic; dipstick technology. If C. difficile toxin A or toxin B is present; a blue/gray line will appear in the test line region indicating a positive result. A red control line must appear for the results to be valid. If C. difficile toxins are not present; only the red control line will appear. An invalid test occurs when no control line appearsThe Test is intended for the qualitative detection of Clostridium difficile toxins A and/or B in human stool samples. This test is intended as an aid in the diagnosis of C.difficile associated disease (CDAD) in patients with symptoms of CDAD. Sekisuki Diagnostics has issued a Product Correction for certain lot numbers of the OSOM C. difficile Toxin A/B Test Kit; because it has been determined that there is potential for false negative results.
Getinge Disinfection Oct-17-2013 Getinge 46-Series – Getinge 46-Series Medical Washer-Disinfectors; Listing # E208196Product Usage: The washer disinfector is used in healthcare facilities where reusable items such as instruments; utensils; anesthesia sets; and glassware are handled for decontamination purposes. Getinge Disinfection AB initiated a voluntary field safety correction for the Getinge 46-Series electrically-heated Washer Disinfectors due to possible overheating.
Harvest Technologies Corporation Oct-17-2013 Graft Delivery System – Harvest Graft Delivery System; Model Number: GDP-10Product Usage: The Harvest Graft Delivery System is intended for the aspiration of bone marrow; autologous blood; plasma; or other body fluids. The system is indicated for die delivery of allograft; autograft; or synthetic bone graft materials to an orthopedic surgical site. In addition; it is designed to facilitate pre-mixing of bone graft materials with the aspirate(s); I.V. fluids; blood; plasma; platelet rich plasma; bone marrow or other specific blood component(s) as deemed necessary by the clinical use requirements. Potential for leur connector to leak or have cracks.
Boston Scientific CRM Corp Oct-17-2013 Boston Scientific TELIGEN ICD – Boston Scientific TELIGEN; Implantable Cardiac Defibrillator models E102; E110; the following models are not available in the US: models F102; F110; F111. Sterilized using ethylene oxide. Boston Scientific; 4100 Hamline Avenue North; St. Paul; MN 55112-5798 USA. Indicated for patients who are at risk for sudden cardiac death due to ventricular arrhythmias and may require pacing support. The performance of a low voltage capacitor in a subset of COGNIS CRT-Ds and TELIGEN ICDs manufactured prior to December 2009; may be compromised over time; causing increased current drain that can lead to premature battery depletion.
Boston Scientific CRM Corp Oct-17-2013 Boston Scientific COGNIS CRT-D – Boston Scientific COGNIS CRT-D; Cardiac Resynchronization Therapy Defibrillator; models N118; N119. The following models are not available in the US: models N106; N107; P106; P107. Sterilized using ethylene oxide. Boston Scientific; 4100 Hamline Avenue North; St. Paul; MN 55112-5798 USA. Indicated for patients who are at risk for sudden cardiac death due to ventricular arrhythmias and may require pacing support. The performance of a low voltage capacitor in a subset of COGNIS CRT-Ds and TELIGEN ICDs manufactured prior to December 2009; may be compromised over time; causing increased current drain that can lead to premature battery depletion.
Siemens Healthcare Diagnostics; Inc. Oct-17-2013 Dimension Vista (R) (UCFP) Flex (R) Reagent Cartridge catalog number K3026 – Dimension Vista (R) Urinary/Cerebrospinal Fluid Protein (UCFP) Flex (R) Reagent Cartridge Lot 11349BBThe Urinary / Cerebrospinal Fluid Protein method is an in vitro diagnostic test for the quantitive measurement of protein in urine and cerebrospinal fluid on the Dimension Vista System. Siemens has confirmed an increase on absorbance errors when calibrating Dimension Vista Urinary/Cerebrospinal Fluid Protein (U CFP) Flex Reagent Cartridge lot 11349 BB.
Abbott Laboratories; Inc Oct-17-2013 Phosphorus Reagent – Clinical Chemistry Phosphorus Reagent The Phosphorus assay is used for the quantitation of phosphorus in human serum; plasma; or urine. Reagent lots 64736UN12; 03991UN13; 51611UN13; 74805UN12; and 03992UN13 have incorrect expiration dates assigned by Supplier.
Synthes USA HQ; Inc. Oct-17-2013 Synthes Midfoot Fusion Bolt – Synthes Midfoot Fusion Bolt 6.5 mm. It is indicated for fracture; fixation; osteotomies; nonunions; and fusions of large bones in the foot and ankle. A post market safety review following several customer complaints indicated additional clarification was necessary in the Midfoot Fusion Bolt Technique Guide to reduce potential for bolt back-out or migration by emphasizing the need for supplemental fixation.
GE Healthcare; LLC Oct-17-2013 GE; Optima CT660 – GE; Optima CT660.Intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data. GE Healthcare has recently become aware of a potential safety issue related with the DMPR function and Screen Saved Images on your scanner which involves Optima CT660; Brivo CT385; Discovery PET/CT 610; Discovery PET/CT 710. The DMPR and Screen Save functionality may possibly generate the sameSeries UID. It has been seen that some PACS may combine series under a patient using only the Series UID
GE Healthcare; LLC Oct-17-2013 GE PET Discovery 610; PET Discovery 710 – GE PET Discovery 610; PET Discovery 710.Intended for head and whole body attenuation corrected Positron Emission Tomography (PET) imaging. GE Healthcare has recently become aware of a potential safety issue related with the DMPR function and Screen Saved Images on your scanner which involves Optima CT660; Brivo CT385; Discovery PET/CT 610; Discovery PET/CT 710. The DMPR and Screen Save functionality may possibly generate the sameSeries UID. It has been seen that some PACS may combine series under a patient using only the Series UID
GE Healthcare; LLC Oct-17-2013 GE Healthcare; Precision 500D; Legacy; RFX; and SFX X. – GE Healthcare; Precision 500D; Legacy; RFX; and SFX X. This table is intended for use in a diagnostic X-ray system to support patients during general purpose radiological procedures in the horizontal; vertical and trendelenburg positions. – The Expedio 500D is designed to perform radiographic and fluoroscopic x-ray examinations. – The Precision 500D R&F X-ray System is intended to be used as a universal diagnostic imaging system for radiographic and fluoroscopic examinations; including general R&F and pediatric examinations. The Precision 500D R&F X-ray Systems are intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic and fluoroscopic exposures of the whole body; skull; spinal column; chest; abdomen; extremities; and other body parts. Applications can be performed with the patient sitting; standing; or lying in the prone or supine position. GE Healthcare has recently become aware of a potential safety issue involving the spotfilm device power assist handle.There is a potential for the internal bolts on the power assist handle to be loose or to loosen and/or fall out. This issue; if present; can result in a loss of calibration and offset of the power assist handle and/or; under extreme condition; sticking of the handle in the ON p
Philips Medical Systems (Cleveland) Inc Oct-17-2013 MX 16-Slice CT Scanner System – MX 16-Slice CT Scanner System.Used as a whole-body computed tomography X-Ray system. A pinch point at the end of the table top can cause injury.
Siemens Healthcare Diagnostics Oct-17-2013 ADVIA 2120/2120i Hematology Systems – ADVIA 2120/2120i Hematology Systems with ADVIA Autoslide connected to it; SMN 10361162 and SMN 10361798 — CLASSIFICATION NAME: Counter; Differential Cell; Automated (Particle Counter)The ADVIA 2120/2120i are hematology systems that utilizes the principles of flow cytometry in order to provide complete blood counts. Siemens determined that if an autosampler rack jam error occurs during operation of an ADVIA 2120/2120i connected to an ADVIA Autoslide; it is possible that the next slide processed by the Autoslide could be labeled with the wrong sample identification information.
Perkin Elmer Health Sciences; Inc. Oct-18-2013 PerkinElmer 226 Sample Collection Device – Perkin Elmer 226 Sample Collection Device; Serial numbers: 06132903 – 06198900.The PerkinElmer 226 Sample Collection Devices are intended to be used as a medium to collect and transport whole blood specimen spots to a laboratory; in newborn screening. The device includes a tear-apart form for the collection of demographic information. Some devices may be contaminated on the back side of the device with glue in the blood application area.
OPTI Medical Systems; Inc Oct-18-2013 Model BP7507 OPTI LION E-Plus Cassette – Model BP7507 OPTI LION E-Plus Cassettes 25 Cassettes with Sample Probes; OPTIMedicalCassettes are consumable used in the OPTI LION Electrolyte Analyzer intended to be used for the measurement of sodium; potassium; chloride; ionized calcium and pH in samples of whole blood; serum; and plasma. OPTI LION E-Plus Cassettes were labeled with an incorrect barcode. The incorrect barcode could perfect the performance of one or more parameters as the product ages. Also a Customer complaint from a distributor reported that a customer was getting QC failures.
SonoSite; Inc. Oct-18-2013 P21x/5-1 MHz transducer – P21x/5-1 MHz transducer; Part Number P07698-23Product Usage: The P21x/5-1 MHz phased array transducer is designed for cardiac; abdominal and obstetric; TCD and orbital exams. It supports 2D with SonoMB Multi Beam Technology and Auto Gain capabilities; SonoHD Imaging Technology; Tissue Harmonic Imaging; M-Mode; Velocity Color Flow Doppler; Color Power Doppler (CDP); Pulsed Wave (PW); TDI Pulsed Wave; and Continuous Wave Doppler. FUJIFILM SonoSite Inc. remove P21x/5-1 Transducer because the firm discovered the Biopsy Bracket Sensor is not working as intended.
Sysmex America Inc Oct-18-2013 Sysmex pocH-100i – pocH-100i; sysmex; Automated Hematology Analyzer; 7.3" x 13.8" x 18.1" / 30.8 lbs.; Sysmex Corporation; 1-5-1 Wakinohama-Kaigandori; Chuo-ku; Kobe 651-0073; Japan; Sysmex America; Inc; One Nelson C. White Pkwy; Mundeline; IL 60060; U.S.A.The Sysmex pocH-100i Automated Hematology Analyzer is an automated cell counter intended for in vitro diagnostic use in CLIA non-waived clinical laboratories (not for Point of Care use in a CLIA waived laboratory). The Complete Blood Cel (CBC) count test parameters include: WBC; RBC; HGB; HCT; MCV; MCH; MCHC; RDW-CV; RDW-SD; PLT; MPV; and NEUT%/#; LYMPH %/#; MIXED %/# (EO; BSO; MONO). The data printed on the thermal printer may omit a digit or decimal point in the results or sample identification number.
Becton Dickinson & Co. Oct-19-2013 Mycobacteria Growth Indicator Tube – BBL ™ MGIT ™ Mycobacteria Growth Indicator Tube; part # 245122; packaged in 100 ct cartons and labeled in part Product Usage: The Mycobacteria Growth Indicator Tube supplemented with Bactec MGIT Growth Supplement and BBL MGIT PANTA antibiotic mixture is intended for the detection and recovery of mycobacteria using the BACTEC MGIT 960 and BACTEC MGIT 320 Systems. Acceptable specimen types are digested and decontaminated clinical specimens (except urine); and sterile body fluids (except blood). An in-vitro diagnostic reagent may be labeled with an incorrect barcode; which when scanned on associated diagnostic instrument may cause a false negative result.
Aesculap; Inc. Oct-21-2013 UNITRAC Pneumatic Retraction Arm – UNITRAC Pneumatic Retraction Arm.A support arm used to hold surgical instruments during surgical procedures. Changes were implemented to the UNITRAC instructions for use to ensure safe use and potentially extend the life of the product. This included recommending the use of Sterile Cover JG901 and new Quick Release Coupling RT02OR to eliminate the need to sterilize the UNITRAC and a functional check was added prior to use to ensure optimal functionality of the UNITRAC system.
AGFA Corp. Oct-21-2013 IMPAX – IMPAX 5.2 DB Server (running Oracle 10.1.0.4.0); medical imaging Picture Archiving and Communication System (PACS). System downtime and/or slow performance may result if software in use is an old version of IMPAX and is not at current supported levels.
Philips Medical Systems (Cleveland) Inc Oct-21-2013 Philips MR Systems: Asset 0.5T; Apollo 0.5T; Infinion 1.5T; Eclipse/Polaris 1.5T; Panorama 0.6T – Philips MR Systems: Asset 0.5T; Apollo 0.5T; Infinion 1.5T; Eclipse/Polaris 1.5T; Panorama 0.6T 1.0T; Magnetic Resonance Imaging Systems intended for clinical/radiologic diagnostic imaging applications. There is a potential for water to collect in the vent pipe elbow in the magnet venting system. Water may freeze; blocking the venting system.
GE Healthcare It Oct-21-2013 Centricity Cardio Imaging – Centricity Cardio Imaging 5.0 is a software only Picture Archiving and Communication System (PACS). Product Usage: It will be sold as a software only device to operate on general purpose computing hardware. Centricity Cardio Imaging receives medical images and other information from various data sources. Information can be stored; communicated; processed and displayed within the system or across computer networks at distributed locations. Centricity Cardio Imaging is intended to assist trained professionals in the viewing; analysis and diagnostic interpretation of images and other information for the diagnosis and treatment of cardiac and vascular disease. These trained professionals include but are not limited to physicians; cardiologists; radiologists; nurses; medical technicians and assistants. Centricity Cardio Imaging is not intended for use in the patient vicinity. GE Healthcare is aware of a potential safety risk where an image labeling situation exists in the Image Viewer software of the Centricity Cardio Imaging product; version 5.0 SP1. Multiple studies may be displayed side by side by selecting "Compare Study" from the Study List; or by opening prior studies in the Patient Folder. In these cases; the Viewer differentiates the studies wityh a label (Curr
Convergent Dental Oct-22-2013 Solea 1.0 – Solea 1.0 Laser Surgical instrument for use in general and plastic surgery and dermatology. Specific error condition could lead to unintended laser emission during laser activation.
Advanced Sterilization Products Oct-22-2013 The STERRAD Sterilization System – STERRAD 200 Sterilizer (Single Door); Part Number: 10201.STERRAD 200 Sterilizer (Double Door); Part Number: 10202.The STERRAD Sterilization System is a low temperature general purpose sterilizer used to sterilize heat and moisture sensitive reusable medical devices. Advanced Sterilization Products (ASP) is recalling the STERRAD 200 Sterilization System because it may emit an odor or smell into the surrounding environment that is not typical to normal operating conditions.
Merit Medical Systems; Inc. Oct-22-2013 Performa Cardiac Multipack Catheter – Merit Medical Performa Angiographic Catheter 5F Multipack. Part numbers 7560-43 and 7560-G3. 4 lots of Performa Cardiac Multipacks contain a JR4.0 catheter with a slight variation in tip shape.
Advanced Sterilization Products Oct-22-2013 STERRAD 100NX Cassettes – STERRAD 100NX CassettesThe STERRAD Sterilization System is a low temperature general purpose sterilizer used to sterilize heat and moisture sensitive reusable medical devices. Advanced Sterilization Products (ASP) is recalling the three lots (13F049; 13F050; 13F051) STERRAD 100NX Cassettes because ASP has determined that the leak indicator on the cassettes is effective for only 12 months of the cassette’s labeled 15-month shelf-life.
Abbott Medical Optics; Inc. Oct-22-2013 STAR Excimer Laser – STAR Excimer Laser System; Model: STAR S2; Catalog Number: 0030-1479; Product is manufactured and distributed by AMO Manufacturing USA; LLC; Milpitas; CAThe STAR Excimer Laser Systems are indicated for laser assisted in situ keratomileusis (LASIK); photorefractive keratectomy (PRK); and phototherapeutic keratectomy (PTK) eye surgery in certain patient populations. This corrective action will address an identified failure of the lamp and illumination system within the laser unit caused by an unexpected failure of a thyristor component on the AC Power Distribution Printed Circuit Board (PCB).
Abbott Medical Optics; Inc. Oct-22-2013 STAR ActiveTrak Excimer Laser System – STAR ActiveTrak Excimer Laser System; Model: STAR S3; Catalog Number: 0030-2450; Product is manufactured and distributed by AMO Manufacturing USA; LLC; Milpitas; CAThe STAR Excimer Laser Systems are indicated for laser assisted in situ keratomileusis (LASIK); photorefractive keratectomy (PRK); and phototherapeutic keratectomy (PTK) eye surgery in certain patient populations. This corrective action will address an identified failure of the lamp and illumination system within the laser unit caused by an unexpected failure of a thyristor component on the AC Power Distribution Printed Circuit Board (PCB).
Synergetics Inc Oct-22-2013 Synergetics 25 gauge Soft Tip Cannula – Synergetics 25 gauge Soft Tip Cannula; packaged in 6 units per box. Catalog number: 30.08.25.Single-use 25 gauge cannula used in vitreoretinal surgery. One lot of 25 gauge Soft-Tip Disposable Cannulas are co-mingled with 23 gauge cannulas; the product is labeled as 25 gauge cannulas.
Abbott Medical Optics; Inc. Oct-22-2013 STAR IR Excimer Laser – STAR Excimer Laser System; Model STAR S4 IR; Catalog Number: 0030-4864; Product is manufactured and distributed by AMO Manufacturing USA; LLCMilpitas; CAThe STAR Excimer Laser Systems are indicated for laser assisted in situ keratomileusis (LASIK); photorefractive keratectomy (PRK); and phototherapeutic keratectomy (PTK) eye surgery in certain patient populations. This corrective action will address an identified failure of the lamp and illumination system within the laser unit caused by an unexpected failure of a thyristor component on the AC Power Distribution Printed Circuit Board (PCB).
Abbott Medical Optics; Inc. Oct-22-2013 STAR Excimer Laser System with Variable Spot Scanning – STAR Excimer Laser System with Variable Spot Scanning; Model: STAR S4; Catalog Number: 0030-4077; Product is manufactured and distributed by AMO Manufacturing USA; LLC; Milpitas; CAThe STAR Excimer Laser Systems are indicated for laser assisted in situ keratomileusis (LASIK); photorefractive keratectomy (PRK); and phototherapeutic keratectomy (PTK) eye surgery in certain patient populations. This corrective action will address an identified failure of the lamp and illumination system within the laser unit caused by an unexpected failure of a thyristor component on the AC Power Distribution Printed Circuit Board (PCB).
DePuy Spine; Inc. Oct-23-2013 PIPELINE¿ LS ACCESS SYSTEM – PIPELINE LS ACCESS SYSTEM; 4th Dilator; 18 mm; InsulatedThe PIPELINE LS Dilators and Holding Clip are intended for sequential dilation of soft tissue and enabling proper placement of the Pipeline LS Retractor. Dilators and Holding Clip are being used for a secondary function of neuromonitoring; for which it is not 510(k) cleared.
DePuy Spine; Inc. Oct-23-2013 PIPELINE¿ LS ACCESS SYSTEM – PIPELINE LS ACCESS SYSTEM; Holding ClipThe PIPELINE LS Dilators and Holding Clip are intended for sequential dilation of soft tissue and enabling proper placement of the Pipeline LS Retractor. Dilators and Holding Clip are being used for a secondary function of neuromonitoring; for which it is not 510(k) cleared.
DePuy Spine; Inc. Oct-23-2013 PIPELINE¿ LS ACCESS SYSTEM – PIPELINE LS ACCESS SYSTEM; 3rd Dilator; 14 mm InsulatedThe PIPELINE LS Dilators and Holding Clip are intended for sequential dilation of soft tissue and enabling proper placement of the Pipeline LS Retractor. Dilators and Holding Clip are being used for a secondary function of neuromonitoring; for which it is not 510(k) cleared.
DePuy Spine; Inc. Oct-23-2013 PIPELINE¿ LS ACCESS SYSTEM – PIPELINE LS ACCESS SYSTEM; 2nd Dilator; 10 mm; InsulatedThe PIPELINE LS Dilators and Holding Clip are intended for sequential dilation of soft tissue and enabling proper placement of the Pipeline LS Retractor. Dilators and Holding Clip are being used for a secondary function of neuromonitoring; for which it is not 510(k) cleared.
DePuy Spine; Inc. Oct-23-2013 PIPELINE¿ LS ACCESS SYSTEM – PIPELINE LS ACCESS SYSTEM; 15 Dilator; 5 mm; InsulatedThe PIPLINE LS Dilators and Holding Clip are intended for sequential dilation of soft tissue and enabling proper placement of the Pipeline LS Retractor. Dilators and Holding Clip are being used for a secondary function of neuromonitoring; for which it is not 510(k) cleared.
DePuy Orthopaedics; Inc. Oct-23-2013 SmartSet¿ GMV Endurance Gentamicin – SmartSet¿ Endurance GMV; Gentamicin; REF 3105-040; Medium Viscosity Antibiotic Bone Cement; Sterile.SmartSet GMV Endurance Gentamicin; bone cements are self-curing; radiopaque; polymethyl methacrylate based cements; containing antibiotic; used for securing a metal or polymeric prosthesis to living bone in arthroplasty procedures where infection by gentamicin-sensitive organisms is a potential risk. The SmartSet? GMV Endurance Gentamicin Bone Cement; product ref: number 3105-040 is intended for use in indications that have not been cleared by the US FDA. The intended use stated in the IFU for the SmartSet? GMV Endurance Gentamicin Bone Cement is for the fixation of prostheses to living bone in arthroplasty procedures of joints in which infection by gentamicin-sensitive organisms is a potentia
Siemens Medical Solutions USA; Inc. Oct-23-2013 Acuson SC2000 – Acuson SC2000 volume imaging ultrasound systems at software version 3.0.Mfg name:Siemens Medical Solutions USA; Inc.Mountain View; CA 94043Medical Device for human use. Ultrasound imaging system used to measure anatomical structures and calculation packages that provide information to the clinician for clinical diagnosis purposes. Software issue results in inaccurate 3D image may result in ablation in wrong location.
Integra LifeSciences Corp. Oct-23-2013 Integra Licox Brain Tissue Oxygen Monitoring Kit – Inegra Licox Brain Tissue Oxygen Monitoring1 x Complete Brain Tunneling Probe Kit REF IT2 Rx Only; Manufacturer GMS- Gesellschaft fur medizinische; Sondentechnik mbH Dofstrasse 2 24247 Melkendorf; Germany Distributed by Integra Neurosciences 311 Enterprise Drive Plainsboro; NJ 08536 USAUsed in direct monitoring of the partial pressure of oxygen. Integra LifeSciences Corporation has determined that there is a possibility that some lots of Licox CMP Brain Tissue Oxygen and Temperature Catheter Kits contain a hex wrench that does not loosen the set screw on the drill bit.
Integra LifeSciences Corp. Oct-23-2013 Integra Licox Brain Tissue Oxygen Monitoring Kit – Integra Licox Brain Tissue Oxygen Monitoring1 x Complete Brain Probe Kit REF IM3.SR Rx Only; Manufacturer GMS- Gesellschaft fur medizinische; Sondentechnik mbH Dofstrasse 2 24247 Melkendorf; Germany Distributed by Integra Neurosciences 311 Enterprise Drive Plainsboro; NJ 08536 USAUsed in direct monitoring of the partial pressure of oxygen. Integra LifeSciences Corporation has determined that there is a possibility that some lots of Licox CMP Brain Tissue Oxygen and Temperature Catheter Kits contain a hex wrench that does not loosen the set screw on the drill bit.
Integra LifeSciences Corp. Oct-23-2013 Integra Licox Brain Tissue Oxygen Monitoring Kit – Integra Licox Brain Tissue Oxygen Monitoring1 x Complete Brain Probe Kit REF IM1.S Rx Only; Manufacturer GMS- Gesellschaft fur medizinische; Sondentechnik mbH Dofstrasse 2 24247 Melkendorf; Germany Distributed by Integra Neurosciences 311 Enterprise Drive Plainsboro; NJ 08536 USAUsed in direct monitoring of the partial pressure of oxygen. Integra LifeSciences Corporation has determined that there is a possibility that some lots of Licox CMP Brain Tissue Oxygen and Temperature Catheter Kits contain a hex wrench that does not loosen the set screw on the drill bit.
Integra LifeSciences Corp. Oct-23-2013 Integra Licox Brain Tissue Oxygen Monitoring Kit – Integra Licox Brain Tissue Oxygen Monitoring1 x Dual Lumen Introducer KitREF IM2_EU Rx Only; Manufacturer GMS- Gesellschaft fur medizinische; Sondentechnik mbH Dofstrasse 2 24247 Melkendorf; Germany Distributed by Integra Neurosciences 311 Enterprise Drive Plainsboro; NJ 08536 USAUsed in direct monitoring of the partial pressure of oxygen. Integra LifeSciences Corporation has determined that there is a possibility that some lots of Licox CMP Brain Tissue Oxygen and Temperature Catheter Kits contain a hex wrench that does not loosen the set screw on the drill bit.
Integra LifeSciences Corp. Oct-23-2013 Integra Licox Brain Tissue Oxygen Monitoring Kit – Integra Licox Brain Tissue Oxygen Monitoring1 x Dual Lumen Introducer KitREF IM2.S_.EU Rx Only; Manufacturer GMS- Gesellschaft fur medizinische; Sondentechnik mbH Dofstrasse 2 24247 Melkendorf; Germany Distributed by Integra Neurosciences 311 Enterprise Drive Plainsboro; NJ 08536 USAUsed in direct monitoring of the partial pressure of oxygen. Integra LifeSciences Corporation has determined that there is a possibility that some lots of Licox CMP Brain Tissue Oxygen and Temperature Catheter Kits contain a hex wrench that does not loosen the set screw on the drill bit.
Integra LifeSciences Corp. Oct-23-2013 Integra Licox Brain Tissue Oxygen Monitoring Kit – Integra Licox Brain Tissue Oxygen Monitoring1 x Complete Brain Probe KitREF IM3.S_.EU Rx Only; Manufacturer GMS- Gesellschaft fur medizinische; Sondentechnik mbH Dofstrasse 2 24247 Melkendorf; Germany Distributed by Integra Neurosciences 311 Enterprise Drive Plainsboro; NJ 08536 USAUsed in direct monitoring of the partial pressure of oxygen. Integra LifeSciences Corporation has determined that there is a possibility that some lots of Licox CMP Brain Tissue Oxygen and Temperature Catheter Kits contain a hex wrench that does not loosen the set screw on the drill bit.
Integra LifeSciences Corp. Oct-23-2013 Integra Licox Brain Tissue Oxygen Monitoring Kit – Integra Licox Brain Tissue Oxygen Monitoring; 1 x Dual Lumen Introducer KitREF IP2; Rx Only; Manufacturer GMS- Gesellschaft fur medizinische; Sondentechnik mbH Dofstrasse 2 24247 Melkendorf; Germany Distributed by Integra Neurosciences 311 Enterprise Drive Plainsboro; NJ 08536 USA.Used in direct monitoring of the partial pressure of oxygen. Integra LifeSciences Corporation has determined that there is a possibility that some lots of Licox CMP Brain Tissue Oxygen and Temperature Catheter Kits contain a hex wrench that does not loosen the set screw on the drill bit.
Integra LifeSciences Corp. Oct-23-2013 Integra Licox Brain Tissue Oxygen Monitoring Kit – Integra Licox Brain Tissue Oxygen Monitoring1 x Complete Brain Probe KitREF IM3.ST_.EU Rx Only; Manufacturer GMS- Gesellschaft fur medizinische; Sondentechnik mbH Dofstrasse 2 24247 Melkendorf; Germany Distributed by Integra Neurosciences 311 Enterprise Drive Plainsboro; NJ 08536 USAUsed in direct monitoring of the partial pressure of oxygen. Integra LifeSciences Corporation has determined that there is a possibility that some lots of Licox CMP Brain Tissue Oxygen and Temperature Catheter Kits contain a hex wrench that does not loosen the set screw on the drill bit.
Integra LifeSciences Corp. Oct-23-2013 Integra Licox Brain Tissue Oxygen Monitoring Kit – Integra Licox Brain Tissue Oxygen Monitoring 1 x Complete Brain Probe KitREF IP2.PRx Only; Manufacturer GMS- Gesellschaft fur medizinische; Sondentechnik mbH Dofstrasse 2 24247 Melkendorf; Germany Distributed by Integra Neurosciences 311 Enterprise Drive Plainsboro; NJ 08536 USAUsed in direct monitoring of the partial pressure of oxygen. Integra LifeSciences Corporation has determined that there is a possibility that some lots of Licox CMP Brain Tissue Oxygen and Temperature Catheter Kits contain a hex wrench that does not loosen the set screw on the drill bit.
Integra LifeSciences Corp. Oct-23-2013 Integra Licox Brain Tissue Oxygen Monitoring Kit – Integra Licox Brain Tissue Oxygen Monitoring; 1 x Complete Brain Probe KitREF IP1.PRx Only; Manufacturer GMS- Gesellschaft fur medizinische; Sondentechnik mbH Dofstrasse 2 24247 Melkendorf; Germany Distributed by Integra Neurosciences 311 Enterprise Drive Plainsboro; NJ 08536 USA.Used in direct monitoring of the partial pressure of oxygen. Integra LifeSciences Corporation has determined that there is a possibility that some lots of Licox CMP Brain Tissue Oxygen and Temperature Catheter Kits contain a hex wrench that does not loosen the set screw on the drill bit.
GE Healthcare Beijing ; Hangwei Medical Systems; Co. LTD Oct-24-2013 GE Brivo OEC – GE Brivo OEC715/785/865 C-Arm; Models: 715 Prime; 785 Essential; and 865 Plus.The QEC Brivo Mobile C-Arm X-Ray Products are designed to provide digital spot film imaging and fluoroscopic image guidance for all adult and pediatric populations for orientations between patient anatomy and surgical instruments. The product is used for general surgical applications and musculoskeletal procedures to visualize; for example; implant localizations or needle positions for aspirations;injections or biopsy. GE is recalling certain lots of GE Brivo OEC715/785/865 C-Arm due to the potential for the wires in the high voltage cable bundle to fail; resulting in loss of system functionality.
Varian Medical Systems; Inc. Oct-24-2013 – VARISOURCE Breast Template System for high-dose rate Brachytherapy. ***INSTRUCTIONS FOR USE*** Breast Bridge & Template System AL13011000 ***Manufacturer: Varian Medical Systems; Inc.; 3100 Hansen Way; Palo Alto; CA 94304 USA The recall was initiated after Varian Medical became aware the Lexan templates of the Breast Bridge Template System could become bent and turn opaque after steam sterilization.
Zimmer; Inc. Oct-25-2013 "CPT¿ Femoral Stem – CPT¿ Femoral Stem (CPT 12/14 STEM SIZE 0 COCR; CPT 12/14 SIZE 0 COCR EXT; CPT 12/14 STEM SIZE 1 COCR; CPT 12/14 SIZE 1 COCR EXTCPT 12/14 STEM SIZE 2 COCR; CPT 12/14 SIZE 2 COCR EXT; CPT 12/14 SIZE 2 COCR 180MM; CPT 12/14 SIZE2 COCR XEXT; CPT 12/14 STEM SIZE 3 COCR; CPT 12/14 SIZE 3 COCR EXT; CPT 12/14 SZ 3 COCR 180MM EXT; CPT 12/14 SIZE 3 COCR XEXT; CPT 12/14 STEM SIZE 4 COCR; CPT 12/14 SIZE 4 COCR EXT; CPT 12/14 SIZE 4 COCR EXT; CPT 12/14 SZ 4 COCR 230MM EXT; CPT 12/14 SZ 4 COCR 260MM EXT; CPT 12/14 SIZE 4 COCR XEXT; CPT 12/14 STEM SIZE 5 COCR; CPT 12/14 SIZE 5 COCR EXT; CPT 12/14 SIZE 5 COCR XEXT; CPT 12/14 STEM 2-180 VALGUSNCK; CPT 12/14 STEM 3-180 VALGUSNCK; CPT 12/14 STEM X-SML COCR; and CPT 12/14 STEM SML COCR).Indicated for cemented use in patients suffering from severe hip pain." The low density polyethylene (LDPE) bag used to package implants adheres to the highly polished surface of the devices.
Zimmer; Inc. Oct-25-2013 NexGen CR-Flex Mobile Bearing Tibial Component 9 – NexGen CR-Flex Mobile Bearing Tibial Component 9 (Not distributed in the United States) The low density polyethylene (LDPE) bag used to package implants adheres to the highly polished surface of the devices.
Zimmer; Inc. Oct-25-2013 "Versys¿ Beaded Fullcoat Femoral Stem – Versys¿ Beaded Fullcoat Femoral Stem (POR FULL-CT FEM ST 11X160MM; VERSYS BEADED FC 11X200MM 8ST; POR FULLCT FEM ST 11 LOW EXT; POR FULLCT FEM ST 11 EXT; POR FLCT FEM STEM LM 11X160MM; POR FULLCT LM FEM ST 11 EXTPOR FULL-CT FEM ST 12X160MMVERSYS BEADED FC 12X200MM 8 ST POR FULLCT FEM ST 12 LOW EXTPOR FLCT FEM ST 12.0X190 STRPOR FULLCT FEM ST 12 EXTPOR FULL-CT FEM ST LM 12X160MMPOR FULLCT LM FEM ST 12 EXTPOR FULL-CT FEM ST 13X160MMVERSYS HIP SYSTEM REVISION FEMORAL BEADED FULLCOAT PLUS COLL POR FULLCT FEM ST 13 LOW EXTPOR FLCT FEM ST 13.5X190 STRPOR FULLCT FEM ST 13 EXTPOR FULL-CT FEM ST LM 13X160MMPOR FULLCT LM FEM ST 13 EXTPOR FULL-CT FEM ST 14X160MMVERSYS BEADED FC 14X200MM 8 ST POR FULLCT FEM ST 14 LOW EXTPOR FULLCT FEM ST 14 EXTPOR FULL-CT FEM ST LM 14X160MMPOR FULLCT LM FEM ST 14 EXTPOR FULL-CT FEM ST 15X160MMVERSYS BEADED FC 15X200MM 8 ST POR FULLCT FEM ST 15 LOW EXTPOR FLCT FEM ST 15.0X190 STRPOR FLCT FEM ST 15.0X250 STRPOR FULLCT FEM ST 15 EXTPOR FULL-CT FEM ST LM 15X160MMPOR FULLCT FEM ST 15 XEXTPOR FULLCT LM FEM ST 15 EXTPOR FULL-CT FEM ST 16X160MMVERSYS BEADED FC 16X200MM 8 ST POR FULLCT FEM ST 16 LOW EXTPOR FLCT FEM ST 16.5X190 STRPOR FLCT FEM ST 16.5X250 STRPOR FULLCT FEM ST 16 EXTPOR FULL-CT FEM ST LM 16X160MMPOR FULLCT FEM ST 16 XEXTPOR FULLCT LM FEM ST 16 EXTPOR FULL-CT FEM ST 17X160MMVERSYS BEADED FC 17X200MM 8 ST POR FULLCT FEM ST 17 EXTPOR FULL-CT FEM ST LM 17X160MMPOR FULLCT FEM ST 17 XEXTPOR FULLCT LM FEM ST 17 EXTPOR FULL-CT FEM ST 18X160MMVERSYS BEADED FC 18X200MM 8 ST POR FLCT FEM ST 18.0X190 STRPOR FLCT FEM ST 18.0X250 STRPOR FULLCT FEM ST 18 EXTPOR FULL-CT FEM ST LM 18X160MMPOR FULLCT FEM ST 18 XEXTPOR FULLCT LM FEM ST 18 EXTPOR FULL-CT FEM ST 19X160MMPOR FLCT FEM ST 19.5X190 STRPOR FLCT FEM ST 19.5X250 STRPOR FULLCT FEM ST 19 EXTPOR FLCT FEM STEM LM 19X160MMPOR FULLCT FEM ST 19 XEXTPOR FULLCT LM FEM ST 19 EXTPOR FULL-CT FEM ST 20X160MMVERSYS BEADED FC 20X200MM 8 ST POR FULLCT FEM ST 20 EXTPOR FLCT FEM STEM LM 20X160MMPOR FULLCT FEM ST 20 XEXTPOR FULLCT LM FEM ST 20 EXTPOR FULL-CT FEM ST 21X160MMPOR FLCT FEM ST 21.0X190 STRPOR FLCT FEM ST 21.0X250 STRPOR FULLCT FEM ST 21 EXTPOR FLCT FEM STEM LM 21X160MMPOR FULLCT FEM ST 21 XEXTPOR FULLCT LM FEM ST 21 EXTPOR FULLCT FEM STEM 22X160MMPOR FLCT FEM ST 22.5X190 STRPOR FLCT FEM ST 22.5X250 STRPOR FULLCT FEM ST 22 EXTPOR FLCT FEM STEM LM 22X160MMPOR FULLCT FEM ST 22 XEXTPOR FULLCT LM FEM ST 22 EXT.Used in total hip replacement." The low density polyethylene (LDPE) bag used to package implants adheres to the highly polished surface of the devices.
Zimmer; Inc. Oct-25-2013 Sidus" Head – Sidus" Head (Not distributed in the United States) The low density polyethylene (LDPE) bag used to package implants adheres to the highly polished surface of the devices.
Zimmer; Inc. Oct-25-2013 Natural-Knee¿ II Femoral Component – Natural-Knee¿ II Femoral Component The low density polyethylene (LDPE) bag used to package implants adheres to the highly polished surface of the devices.
Zimmer; Inc. Oct-25-2013 Gender Solutions" Patello-Femoral Component – Gender Solutions" Patello-Femoral Component The low density polyethylene (LDPE) bag used to package implants adheres to the highly polished surface of the devices.
Zimmer; Inc. Oct-25-2013 Zimmer¿ Unicompartmental Knee Femoral Component – Zimmer¿ Unicompartmental Knee Femoral Component.Indicated for patients with painful and/or disabling knee joint. The low density polyethylene (LDPE) bag used to package implants adheres to the highly polished surface of the devices.
Zimmer; Inc. Oct-25-2013 Metasul¿ Head – Metasul¿ Head.Intended for use either with or without bone cement in total hip arthroplasty. The low density polyethylene (LDPE) bag used to package implants adheres to the highly polished surface of the devices.
Zimmer; Inc. Oct-25-2013 NexGen¿ Femoral Component – NexGen¿ Femoral Component (CR-FLEX GSF POR FEM; C-L; CR-FLEX GSF POR FEM; C-R; CR-FLEX GSF POR FEM; C-L MINUS; CR-FLEX GSF POR FEM; C-R MINUS; CR-FLEX GSF POR FEM; D-L; CR-FLEX GSF POR FEM; D-R CR-FLEX GSF POR FEM; D-L MINUS; CR-FLEX GSF POR FEM; D-R MINUS CR-FLEX GSF POR FEM; E-L; CR-FLEX GSF POR FEM; E-R; CR-FLEX GSF POR FEM; E-L MINUS; CR-FLEX GSF POR FEM; E-R MINUS; CR-FLEX GSF POR FEM; F-L ; CR-FLEX GSF POR FEM; F-R; CR-FLEX GSF POR FEM; F-L MINUS; CR-FLEX GSF POR FEM; F-R MINUS; CR-FLEX GSF POR FEM; G-L CR-FLEX GSF POR FEM; G-R; CR-FLEX GSF POR FEM; G-L MINUS CR-FLEX GSF POR FEM; G-R MINUS; NEXGEN GSF POROUS FEMORAL LPS FLEX SIZE C; LEFT; NEXGEN GSF POROUS FEMORAL LPS FLEX SIZE C; RIGHT; NEXGEN GSF POROUS FEMORAL LPS FLEX SIZE D; LEFT; NEXGEN GSF POROUS FEMORAL LPS FLEX SIZE D; RIGHT; LPS-FLEX GSF POR FEM; E-L; NEXGEN GSF POROUS FEMORAL LPS FLEX SIZE E; RIGHT; NEXGEN GSF POROUS FEMORAL LPS FLEX SIZE F; LEFT; NEXGEN GSF POROUS FEMORAL LPS FLEX SIZE F; RIGHT; NEXGEN GSF POROUS FEMORAL LPS FLEX SIZE G; LEFT; and NEXGEN GSF POROUS FEMORAL LPS FLEX SIZE G; RIGHT).Provides increased flexion capability. The low density polyethylene (LDPE) bag used to package implants adheres to the highly polished surface of the devices.
Zimmer; Inc. Oct-25-2013 Natural-Knee¿ Flex Femoral Component – Natural-Knee¿ Flex Femoral Component.Provides increased flexion capability. The low density polyethylene (LDPE) bag used to package implants adheres to the highly polished surface of the devices.
Zimmer; Inc. Oct-25-2013 CoCr Head – CoCr Head (Not distributed in the United States)Used in total hip replacement. The low density polyethylene (LDPE) bag used to package implants adheres to the highly polished surface of the devices.
Zimmer; Inc. Oct-25-2013 NexGen¿ Femoral Component – NexGen¿ Femoral Component (CR-FLEX GSF PRECOAT SZ C-L; CR-FLEX GSF PRECOAT SZ C-R ; CR-FLEX GSF PCT SZ C-L MINUS; CR-FLEX GSF PCT SZ C-R MINUS ;CR-FLEX GSF PRECOAT SZ D-L; CR-FLEX GSF PRECOAT SZ D-R ;CR-FLEX GSF PCT SZ D-L MINUS ; CR-FLEX GSF PCT SZ D-R MINUS ;CR-FLEX GSF PRECOAT SZ E-L CR-FLEX GSF PRECOAT SZ E-R ;CR-FLEX GSF PCT SZ E-L MINUS ;CR-FLEX GSF PCT SZ E-R MINUS ;CR-FLEX GSF PRECOAT SZ F-L ;CR-FLEX GSF PRECOAT SZ F-R ;CR-FLEX GSF PCT SZ F-L MINUS ;CR-FLEX GSF PCT SZ F-R MINUS ;CR-FLEX GSF PRECOAT SZ G-L ;CR-FLEX GSK PRECOAT SZ G-R ;CR-FLEX GSF PCT SZ G-L MINUS ;CR-FLEX GSF PCT SZ G-R MINUS ; LPS-FLEX GSF OPT SZ C-L ; LPS-FLEX GSF OPT SZ C-R ;LPS-FLEX GSF OPT SZ D-L ;LPS-FLEX GSF OPT SZ D-R ;LPS-FLEX GSF OPT SZ E-L ;LPS-FLEX GSF OPT SZ E-R ;LPS-FLEX GSK OPT SZ F-L ;LPS-FLEX GSF OPT SZ F-R ;LPS-FLEX GSF OPT SZ G-L ; LPS-FLEX GSF OPT SZ G-R ;CR-FLEX PCT FEM B-L; CR-FLEX PCT FEM B-R; CR-FLEX PCT FEM C-L; CR-FLEX PCT FEM C-R; CR-FLEX PCT FEM C-L MINUS; CR-FLEX PCT FEM C-R MINUS; CR-FLEX PCT FEM D-L; CR-FLEX PCT FEM D-R; CR-FLEX PCT FEM D-L MINUS; CR-FLEX PCT FEM D-R MINUS; CR-FLEX PCT FEM E-L; CR-FLEX PCT FEM E-R; CR-FLEX PCT FEM E-L MINUS; CR-FLEX PCT FEM E-R MINUS; CR-FLEX PCT FEM F-L; CR-FLEX PCT FEM F-R; CR-FLEX PCT FEM F-L MINUS; CR-FLEX PCT FEM F-R MINUS; CR-FLEX PCT FEM G-L; CR-FLEX PCT FEM G-R; CR-FLEX PCT FEM G-L MINUS; CR-FLEX PCT FEM G-R MINUS; CR-FLEX POR FEM B-L; CR-FLEX POR FEM B-R; CR-FLEX POR FEM C-L; CR-FLEX POR FEM C-R; CR-FLEX POR FEM C-L MINUS; CR-FLEX POR FEM C-R MINUS; CR-FLEX POR FEM D-L; CR-FLEX POR FEM D-R; CR-FLEX POR FEM D-L MINUS; CR-FLEX POR FEM D-R MINUS; CR-FLEX POR FEM E-L; CR-FLEX POR FEM E-R; CR-FLEX POR FEM E-L MINUS; CR-FLEX POR FEM E-R; MINUS; CR-FLEX POR FEM F-L; CR-FLEX POR FEM F-R ;CR-FLEX POR FEM F-L MINUS; CR-FLEX POR FEM F-R MINUS; CR-FLEX POR FEM G-L; CR-FLEX POR FEM G-R; CR-FLEX POR FEM G-L MINUS CR-FLEX POR FEM G-R MINUS; CR-FLEX OPT FEM B-L; CR-FLEX OPT FEM B-R; CR-FLEX OPT FEM C-L; CR-FLEX OPT FEM C-R; CR-FLEX OPT FEM C-L MINUS; CR-FLEX OPT FEM C-R MINUS; CR-FLEX OPT FEM D-L; CR-FLEX OPT FEM D-R; CR-FLEX OPT FEM D-L MINUS; CR-FLEX OPT FEM D-R MINUS; CR-FLEX OPT FEM E-L; CR-FLEX OPT FEM E-R; CR-FLEX OPT FEM E-L MINUS; CR-FLEX OPT FEM E-R MINUS; CR-FLEX OPT FEM F-L; CR-FLEX OPT FEM F-R; CR-FLEX OPT FEM F-L MINUS; CR-FLEX OPT FEM F-R MINUS; CR-FLEX OPT FEM G-L; CR-FLEX OPT FEM G-R; CR-FLEX OPT FEM G-L MINUS; CR-FLEX OPT FEM G-R MINUS; LPS-FLEX CO-NID FEM A-L ; LPS-FLEX CO-NID FEM A-R ; LPS-FLEX RECOAT FEMORAL A-L; LPS-FLEX PRECOAT FEMORAL A-R; LPS-FLEX CO-NID FEM B-L ; LPS-FLEX CO-NID FEM B-R ; LPS-FLEX PRECOAT FEMORAL B-L; LPS-FLEX PRECOAT FEMORL B-R; LPS-FLEX CO-NID FEM C-L ; LPS-FLEX CO-NID FEM C-R ; LPS-FLEX PRECOAT FEMORAL C-L; LPS-FLEX PRECOAT FEMORAL C-R; LPS-FLEX CO-NID FEM D-L ; LPS-FLEX CO-NID FEM D-R ; LPS-FLEX PRECOAT FEMORAL D-L; LPS-FLEX PRECOAT FEMORAL D-R; LPS-FLEX CO-NID FEM E-L ; LPS-FLEX CO-NID FEM E-R ; LPS-FLEX PRECOAT FEMORAL E-L; LPS-FLEX PRECOAT FEMORAL E-R; LPS-FLEX CO-NID FEM F-L ; LPS-FLEX CO-NID FEM F-R ; LPS-FLEX PRECOAT FEMORAL F-L; LPS-FLEX PRECOAT FEMORAL F-R; LPS-FLEX CO-NID FEM G-L ; LPS-FLEX CO-NID FEM G-R ; LPS-FLEX PRECOAT FEMORAL G-L; LPS-FLEX PRECOAT FEMORAL G-R; LPS-FLEX PRECOAT FEMORAL H-L; LPS-FLEX PRECOAT FEMORAL H-R ; LPS-FLEX POROUS FEMORAL B-L ; LPS-FLEX POROUS FEMORAL B-R ; LPS-FLEX POROUS FEMORAL C-L ; LPS-FLEX POROUS FEMORAL C-R LPS-FLEX POROUS FEMORAL D-L ; LPS-FLEX POROUS FEMORAL D-R ; LPS-FLEX POROUS FEMORAL E-L ; LPS-FLEX POROUS FEMORAL E-R ; LPS-FLEX POROUS FEMORAL F-L ; LPS-FLEX POROUS FEMORAL F-R ;LPS-FLEX POROUS FEMORAL G-L ; LPS-FLEX POROUS FEMORAL G-R ; LPS-FLEX POROUS FEMORAL H-L ; LPS-FLEX POROUS FEMORAL H-R ; LPS-FLEX OPTION FEMORAL A-L; LPS-FLEX OPTION FEMORAL A-R; LPS-FLEX OPTION FEMORAL B-L; LPS-FLEX OPTION FEMORAL B-R; LPS-FLEX OPTION FEMORAL B-L ; LPS-FLEX OPTION FEMORAL B-R ; LPS-FLEX OPTION FEMORAL C-L; LPS-FLEX OPTION FEMORAL C-R; LPS-FLEX OPTION FEMORAL C-L; LPS-FLEX OPTION FEMORAL C-R; LPS-FLEX OPTI The low density polyethylene (LDPE) bag used to package implants adheres to the highly polished surface of the devices.
Zimmer; Inc. Oct-25-2013 Multipolar¿ Bipolar Cup – Multipolar¿ Bipolar Cup METAL SHELL 38 MM OD through 71 MM OD.Indicated in fracture dislocation of the hip. The low density polyethylene (LDPE) bag used to package implants adheres to the highly polished surface of the devices.
Philips Medical Systems (Cleveland) Inc Oct-25-2013 Ingenuity TF PET/CT – Ingenuity TF PET/CTDiagnostic 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 Oran 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 regional cerebral activity from PET images. Cardiac imaging software provides functionality for quantification of cardiology images and data sets including but not limited to myocardial perfusion for the display of wall motion and quantification ventricular or left-function parameters from gated myocardial perfusion studies and for the 3D alignment of coronary artery images from CT coronary angiography onto the myocardium. Both subsystems (PET and CT) can also be operated. Issues with the Ingenuity TF PET/CT Software Version 4.0 could pose a risk for patients in the event that a patient rescan were to require reinjection of PET radiopharmaceutical.
Cordis Corporation Oct-25-2013 Cordis OPTEASE Vena Cava Filter – Cordis OPTEASE Vena Cava FilterIs indicated for use in the prevention of recurrent pulmonary embolism (PE) via percutaneous placement in the vena cava in the following situations: – Pulmonary thromboembolism when anticoagulants are contraindicated; – Failure of anticoagulant therapy for thromboembolitic disease; – Emergency treatment following massive pulmonary embolism where anticipate benefits of conventional therapy are reduce; and – Chronic; recurrent pulmonary embolism where anticoagulant therapy has failed; or is contraindicated. Cordis identified a printing error on one unit of the Optease Vena Cava Filter; in which the orientation arrow for the femoral approach was printed in the incorrect direction. The error resulted in the filter being implanted upside down; requiring and additional percutaneous procedure to retrieve the filter.
HemoCue AB Oct-25-2013 HemoCue¿ Urine Albumin Microcuvettes – HemoCue¿ Urine Albumin Microcuvettes; 25 Microcuvettes HemoCue AB Angelholm; SwedenThe quantitative; rapid; turbidimetric immunoassay of albumin in human urine using a specially designed analyzer; the HemoCue Albumin 201 Analyzer. The system can be used for the quantitative determination of low levels of albumin in urine for the purpose of screening for; diagnosing; monitoring and to supplement the clinical evidence in the treatment of microalbuminuria. The system is designed for testing using spot samples or timed collections. A quantitative result is obtained within 90 seconds. HemoCue Urine Albumin Microcuvettes are for in vitro diagnostic use only. The HemoCue Albumin 201 Analyzer is only to be used with HemoCue Urine Albumin Microcuvettes HemoCue AB has become aware of a production related problem involving punctured HemoCue? Urine Albumin Microcuvettes single pack pouches.
Medtronic Vascular; Inc. Oct-25-2013 Valiant Thoracic Stent Graft with Captivia Delivery System; Talent Thoracic Stent Graft with the Cap – Valiant Thoracic Stent Graft with Captivia Delivery System;Talent Thoracic Stent Graft with the Captivia Delivery System. Firm received reports of difficulty in flushing the graft cover of the delivery system during device preparation as required by IFU.
Maquet Medical Systems USA Oct-25-2013 CARDIOHELPi – MAQUET Getinge Group CARDIOHELP Base Unit REF 70104.7999 REF 70104.8012 Manufactured for: MAQUET Cardiopulmonary AG Made in Germany.Cardiopulmonary support system. It has come to the attention of MAQUET that in certain rare instances; the CARDIOHELP-i device may display an error message with audible alarm; indicating "battery defective." The alarm will occur-upon start up or when the main power supply is unplugged from the main power source. The human machine interface touch screen of the CARDIOHELP-i device may gradually become black due to the human mach
Intuitive Surgical; Inc. Oct-28-2013 da Vinci Si Surgical System IS3000 – da Vinci Si Surgical System IS3000 with the da Vinci Surgeon Console which contains a high Resolution Stereoscopic Viewer.Intended to assist in the accurate control of Intuitive Surgical Endoscopic instruments. Improper restraints during transportation of the da Vinci system could cause the HRSV Monitor to become loose from its mount.
Stryker Instruments Div. of Stryker Corporation Oct-28-2013 TPS Micro Driver – REF 5100-088; TPS Micro Driver; For Use with Stryker Total Performance System Caution Federal Law (USA) restricts the device to use by or on the order of a physicianDriver; Wire and Bone Drill; The Stryker Total Performance System (TPS) is intended for use in the cutting; drilling; reaming; decorticating and smoothing of bone and other bone related tissues for a variety of applications such as ENT; dental; orthopedic; maxillofacial; spinal; and plastic surgery. The instruments are also used in the placement of screws; wires; pins; and other fixation devices. It was discovered that the silicone potting failed to properly cure after undergoing the prescribed curing possess. The potting material is used to insulate; stabilize and provide a moisture barrier to the TPS MicroDriver main Printed Circuit Board Assembly (PCBA). Inadequate cure of the silicone potting could potentially allow it to leak to the outside of the handpiece or cause an electrical ma
bioMerieux; Inc. Oct-28-2013 chromID Salmonella Agar – chromID Salmonella Agar; Reference No. 43621.A selective isolation and differentiation medium for the detection of Salmonella in human specimens. Complaints for Salmonella strains growing on this medium producing an uncharacteristic white colored colony instead of the expected pale pink to mauve colored colonies. This could potentially lead to Salmonella colonies not being detected.
Philips Medical Systems (Cleveland) Inc Oct-28-2013 BrightView XCT – BrightView XCT is a gamma camera for Single Photon Emission Computed Tomography (SPECT); one unit per box.BrightView XCT is a gamma camera for Single Photon Emission Computed Tomography (SPECT) and integrates with an attenuation device consisting of flat panel x-ray imaging components. BrightView XCT produces non-attenuation corrected SPECT images and attenuation corrected SPECT images with x-ray transmission data that may also be used for scatter correction. The nuclear medicine images and the XCT images may be registered and displayed in a fused format (overlaid in the same orientation) to provide anatomical localization of the nuclear medicine data. Philips received reports from the field that the Flat Panel Detector (FPD) does not always remain securely latched in the stowed position.
Baxter Healthcare Corp. Oct-29-2013 CLEARLINK System Non-DEHP Microbore Three Lead Catheter Extension Set with LAV – Baxter CLEARLINK System Non-DEHP Three Lead Extension Set. 6.0" (15 cm); 1.0 mL; Luer Activated Valve; male Luer Lock Adapter; Sterile; nonpyrogenic; Baxter Healthcare Corporation; Deerfield IL 60015.For use with a vascular access device for the administration of drugs and solutions. The Clearlink Luer Activated Valve is an in-line injection site; which can be connected to standard male Luer adapters for continuous or intermittent fluid administration or the withdrawal of fluids. The firm is issuing a voluntary recall due to the potential for pinholes in the packaging. Pinholes are a breach in the sterile barrier and could lead to potential contamination.
Small Bone Innovations; Inc. Oct-29-2013 Small Bone Innovations (see also Product Description) – Small Bone Innovations (SBi) rHead Radial Stem; rHead Recon Radial System; rHead Radial Stem Lateral Assembly; rHead Radial Stem 6mm Collar; rHead Recon Radial Stem 6mm Collar; rHead Radial Stem Lateral Assembly 6mm Collar; rHead Standard Extended Stem; rHead Radial Stem Plasma Coated; rHead Recon Radial Stem Plasma Coated; rHead Radial Stem 6mm Collar Plasma Coated; rHead Recon Radial Stem 6mm Collar Plasma Coated; uHead Ulnar Stem Standard; uHead Ulnar Stem 20mm Collar packaged in a sterile pouch inside a shrink-wrapped box. The recall was initiated due to an increased risk of implants breaching the sterile pouches inside the shrink-wrapped box.
Siemens Healthcare Diagnostics Inc Oct-29-2013 Siemens Healthcare – Siemens RAPIDLab¿ 1245 system blood gas analyzerProduct Usage:RAPIDLab 1200 Systems: The Rapidlab 1200 systems are intended for in vitro diagnostic use by healthcare professionals in the quantitative testing of human whole blood. The systems can determine the following parameters: RAPIDLab 1240 pH; pC02; p02 RAPIDLab 1245 pH; pC02; p02; tHb; nBili; F02Hb; FCOHb; FMetHb; FHHb RAPIDLab 1260 pH; pC02; p02; Na+; K+; Ca++; Cl-; glucose; lactate RAPIDLab 1265 pH; pC02; p02; Na+; K+; Ca++; Cl-; glucose; lactate; tHb; nBili; F02Hb; FCOHb; FMetHb; FHHb RAPIDPoint? 400 Series; RAPIDPoint? 500; orRAPIDLab? 1200 Series blood gas analyzer; users can inadvertently enter a wrong patient ID on the demographics screen; which ultimately could lead to a misidentification of the sample
Siemens Healthcare Diagnostics Inc Oct-29-2013 Siemens Healthcare – Siemens RAPIDLab¿ 1260 system blood gas analyzerProduct Usage:RAPIDLab 1200 Systems: The Rapidlab 1200 systems are intended for in vitro diagnostic use by healthcare professionals in the quantitative testing of human whole blood. The systems can determine the following parameters: RAPIDLab 1240 pH; pC02; p02 RAPIDLab 1245 pH; pC02; p02; tHb; nBili; F02Hb; FCOHb; FMetHb; FHHb RAPIDLab 1260 pH; pC02; p02; Na+; K+; Ca++; Cl-; glucose; lactate RAPIDLab 1265 pH; pC02; p02; Na+; K+; Ca++; Cl-; glucose; lactate; tHb; nBili; F02Hb; FCOHb; FMetHb; FHHb RAPIDPoint? 400 Series; RAPIDPoint? 500; orRAPIDLab? 1200 Series blood gas analyzer; users can inadvertently enter a wrong patient ID on the demographics screen; which ultimately could lead to a misidentification of the sample
Siemens Healthcare Diagnostics Inc Oct-29-2013 Siemens Healthcare – Siemens RAPIDLab¿ 1240 system blood gas analyzerProduct Usage:RAPIDLab 1200 Systems: The Rapidlab 1200 systems are intended for in vitro diagnostic use by healthcare professionals in the quantitative testing of human whole blood. The systems can determine the following parameters: RAPIDLab 1240 pH; pC02; p02 RAPIDLab 1245 pH; pC02; p02; tHb; nBili; F02Hb; FCOHb; FMetHb; FHHb RAPIDLab 1260 pH; pC02; p02; Na+; K+; Ca++; Cl-; glucose; lactate RAPIDLab 1265 pH; pC02; p02; Na+; K+; Ca++; Cl-; glucose; lactate; tHb; nBili; F02Hb; FCOHb; FMetHb; FHHb RAPIDPoint? 400 Series; RAPIDPoint? 500; orRAPIDLab? 1200 Series blood gas analyzer; users can inadvertently enter a wrong patient ID on the demographics screen; which ultimately could lead to a misidentification of the sample
Siemens Healthcare Diagnostics Inc Oct-29-2013 Siemens Healthcare – Siemens RAPIDPoint¿ 500 system blood gas analyzerProduct Usage:RAPIDPoint 500 System: The RAPIDPoint 500 system is designed for professional use in a point-of-care or laboratory environment. This system tests blood gases; electrolytes; metabolites; total hemoglobin; and hemoglobin derivatives in arterial; venous; and capillary whole blood samples. The following parameters are tested: pH; pC02; p02; Na+; K+; Ca++; Cl-; glucose; lactate; tHb; F02Hb; FCOHb; FMetHb; FHHb; nBili RAPIDPoint? 400 Series; RAPIDPoint? 500; orRAPIDLab? 1200 Series blood gas analyzer; users can inadvertently enter a wrong patient ID on the demographics screen; which ultimately could lead to a misidentification of the sample
Siemens Healthcare Diagnostics Inc Oct-29-2013 Siemens Healthcare – Siemens RAPIDPoint¿¿ 405 system blood gas analyzerProduct PUsage:These systems are intended for near-patient and laboratory testing of blood gases; electrolytes; metabolites; total hemoglobin; and hemoglobin derivatives in arterial; venous; and capillary whole blood samples. The systems are capable of determining the following parameters: RAPIDPoint 400 pH; pC02; p02; Na+; K+; Ca++; Cl-; glucose; Hct RAPIDPoint 405 pH; pC02; p02; Na+; K+; Ca++; Cl-; glucose; tHb; F02Hb; FCOHb; FMetHb; FHHb; nBili RAPIDPoint? 400 Series; RAPIDPoint? 500; orRAPIDLab? 1200 Series blood gas analyzer; users can inadvertently enter a wrong patient ID on the demographics screen; which ultimately could lead to a misidentification of the sample
Siemens Healthcare Diagnostics Inc Oct-29-2013 Siemens Healthcare – Siemens RAPIDLab¿ 1265 system blood gas analyzerProduct Usage:RAPIDLab 1200 Systems: The Rapidlab 1200 systems are intended for in vitro diagnostic use by healthcare professionals in the quantitative testing of human whole blood. The systems can determine the following parameters: RAPIDLab 1240 pH; pC02; p02 RAPIDLab 1245 pH; pC02; p02; tHb; nBili; F02Hb; FCOHb; FMetHb; FHHb RAPIDLab 1260 pH; pC02; p02; Na+; K+; Ca++; Cl-; glucose; lactate RAPIDLab 1265 pH; pC02; p02; Na+; K+; Ca++; Cl-; glucose; lactate; tHb; nBili; F02Hb; FCOHb; FMetHb; FHHb RAPIDPoint? 400 Series; RAPIDPoint? 500; orRAPIDLab? 1200 Series blood gas analyzer; users can inadvertently enter a wrong patient ID on the demographics screen; which ultimately could lead to a misidentification of the sample
Siemens Healthcare Diagnostics Inc Oct-29-2013 Siemens Healthcare – Siemens RAPIDPoint¿ 400 system blood gas analyzerProduct Usage:These systems are intended for near-patient and laboratory testing of blood gases; electrolytes; metabolites; total hemoglobin; and hemoglobin derivatives in arterial; venous; and capillary whole blood samples. The systems are capable of determining the following parameters: RAPIDPoint 400 pH; pC02; p02; Na+; K+; Ca++; Cl-; glucose; Hct RAPIDPoint 405 pH; pC02; p02; Na+; K+; Ca++; Cl-; glucose; tHb; F02Hb; FCOHb; FMetHb; FHHb; nBili RAPIDPoint? 400 Series; RAPIDPoint? 500; orRAPIDLab? 1200 Series blood gas analyzer; users can inadvertently enter a wrong patient ID on the demographics screen; which ultimately could lead to a misidentification of the sample
HemoCue AB Oct-29-2013 HemoCue Hb 201 Microcuvettes – HemoCue¿ Hb 201 Microcuvettes; carton/4 boxes/25 pouches of Microcuvettes; HemoCue AB Angelholm; Sweden HemoCue AB has become aware of a production related problem involving punctured HemoCue Hb 201 Microcuvettes single pack pouches.
S.A.E. AFIKIM Oct-30-2013 Breeze C Scooter – Breeze C Scooter is a motorized electric scooter for elderly people. Brand name Breeze; model C. It is intended to provide increased mobility for elderly and/or disabled person and it is also an aid to independent living.Products can be identified by their color; the recalled products are either metallic blue or metallic silver. The products have two rear wheels and have either one or two wheels in the front. The scooters have an adjustable swivel seat and a front storage basket; some scooters may be fitted with an optional larger rear basket. Breeze C Scooter; motorized 3-wheeled electric scooter for elderly people; is recalled because it may become unresponsive during operation due to an electrical contact which may fault due to extensive wear; which potentially could result in the driver not being able to stop the scooter during operation except by turning off the ignition key.
Synthes USA HQ; Inc. Oct-30-2013 Synthes Application Instrument Sternal Zip Flex System – Synthes Application Instrument Sternal Zip Flex Systemintended for use in primary or secondary closure/repair of the sternum following sternotomy or fracture of the sternum to stabilize the sternum and promote fusion When using the 1st generation Zip Fix Application Instrument it is possible to cut the implant while the tensioning trigger is being squeezed which could lead to loosening of the implant.
Ge Healthcare It Oct-30-2013 GE Centricity PACS-IW – Centricity PACS IW by GE Healthcare Dynamic Imaging Solutions is a device that receives medical images (including mammograms) and data from various imaging sources. Images and data can be stored; communicated; processed and displayed within the system or across computer networks at distributed locations. Lossy compressed mammographic images and digitized film screen images may only be interpreted using an FDA approved monitor that offers at least 5 M pixel resolution and meets other technical specifications reviewed and accepted by the FDA. Typical users of this system are trained professionals; including but not limited to physicians; radiologists; nurses; medical technicians an assistants. Multiple issues were identified with the GE Centricity PACS-IW system that could pose a safety risk to patients. These issues include:1) With Auto-Fetch in use another patient’s image may appear without user’s intention. 2.a) In the case where dose administration time and image acquisition time fall on either side of midnight; the value will be under reported and close to zero for all pixe
GE Healthcare It Oct-30-2013 GE Centricity PACS – The Centricity PACS Workstation is intended for use as a primary diagnostic and analysis tool for diagnostic images by trained healthcare professionals; including radiologists; physicians; technologists; clinicians and nurses. It is also intended for use as a clinical review workstation throughout the healthcare facility. The workstation interface provides the user with a means to display; manipulate; archive; print and export images when connected with the Centricity PACS infrastructure. GE has recently become aware of potential issues due to out of context issues associated with specific workflows of the Centricity PACS RA1000 workstation. These issues are as follows: 1) In Centricity RIS-IC; and a RIS-Driven integration; the "close" button closes the exam in RIS-IC; but does not close the exam in Centricity PACS RA1000 Workstation. 2) Interrupted workflow could break the
Baxter Healthcare Corp. Oct-30-2013 Vented Spike Adapter – Vented Spike Adapter Product Code 2C0471; Sterile; nopyrogenic. Manufactured by an affiliate of Baxter Healthcare Corporation; Clintec Nutrition Division; Deerfield IL 60015 USA.An IV transfer device; used to transfer fluids in pharmacy compounding system. Potential tears in the pouch of six lots of Vented Spike Adapter Product Code 2C0471
Intuitive Surgical; Inc. Oct-30-2013 Single Site Bipolar Maryland Forceps – Single Site Bipolar Maryland ForcepsIntuitive Surgical; Sunnyvale; CA. 94086The Intuitive Surgical da Vinci Single-Site Instruments and Accessories used with the da Vinci Si Surgical System (IS3000) are indicated for use by trained physicians in an operating room environment for endoscopic manipulation of tissue; grasping; cutting; blunt and sharp dissection; approximation; clip-ligation; electrocautery and suturing during single incision laparoscopic cholecystectomy; benign hysterectomy and salpingo-oophorectomy with the da Vinci Single-Site Instruments and Accessories; including graspers; dissectors; needle drivers; scissors; suction irrigators; monopolar cautery; bipolar cautery; 5 mm curved cannulae; 5 mm and 10 mm straight cannulae; flexible blunt obturators; and the 5mm Single-Site Port. 2. A limited number of FDA-cleared instruments for da Vinci Single Site use; Bipolar Maryland and curved needle Driver; were shipped without the correct revision of the user manual which provided added instruction for use of these additional Single Site instruments including indication; warnings and precautions.
Intuitive Surgical; Inc. Oct-30-2013 Single Site Curved Needed Driver – Single Site Curved Needed DriverIntuitive Surgical; Sunnyvale; CA. 94086The Intuitive Surgical da Vinci Single-Site Instruments and Accessories used with the da Vinci Si Surgical System (IS3000) are indicated for use by trained physicians in an operating room environment for endoscopic manipulation of tissue; grasping; cutting; blunt and sharp dissection; approximation; clip-ligation; electrocautery and suturing during single incision laparoscopic cholecystectomy; benign hysterectomy and salpingo-oophorectomy with the da Vinci Single-Site Instruments and Accessories; including graspers; dissectors; needle drivers; scissors; suction irrigators; monopolar cautery; bipolar cautery; 5 mm curved cannulae; 5 mm and 10 mm straight cannulae; flexible blunt obturators; and the 5mm Single-Site Port. A limited number of FDA-cleared instruments for da Vinci Single Site use; Bipolar Maryland and curved needle Driver; were shipped without the correct revision of the user manual which provided added instruction for use of these additional Single Site instruments including indication; warnings and precautions.
Fujinon Inc Oct-30-2013 Fujinon/Fujifilm – Fujinon/Fujifilm Ultrasonic EndoscopeIntended to provide ultrasonic images of submucosal and peripheral organs of the upper gastrointestinal tract for observation; diagnosis and endoscopic treatment. A limited number of endoscopes were shipped to FMSU-ESD with a manufacturing defect which included missing set screws used to more securely attach the Forceps Inlet (biopsy inlet port) to the endoscope.
Toshiba American Medical Systems Inc Oct-30-2013 Xario Diagnostic Ultrasound System SSA-660A – Xario Diagnostic Ultrasound System SSA-660AUsed for routine diagnostic imaging The firm initiated this recall of certain Toshiba Diagnostic Ultrasound Systems because it has been found that under certain conditions; the temperature of the transducer head may increase in 2D+PW mode or 2D+CDI (POWER; ADF) +PW mode. When the system is used under both conditions listed below; the temperature of the transducer head connected to the system may increase in temperature and possibly
Toshiba American Medical Systems Inc Oct-30-2013 Xario XG Diagnostic Ultrasound System SSA-680A – Xario XG Diagnostic Ultrasound System SSA-680AUsed for routine diagnostic imaging The firm initiated this recall of certain Toshiba Diagnostic Ultrasound Systems because it has been found that under certain conditions; the temperature of the transducer head may increase in 2D+PW mode or 2D+CDI (POWER; ADF) +PW mode. When the system is used under both conditions listed below; the temperature of the transducer head connected to the system may increase in temperature and possibly
Toshiba American Medical Systems Inc Oct-30-2013 Aplio XG Diagnostic Ultrasound System SSA-790A – Aplio XG Diagnostic Ultrasound System SSA-790AUsed for routine diagnostic imaging The firm initiated this recall of certain Toshiba Diagnostic Ultrasound Systems because it has been found that under certain conditions; the temperature of the transducer head may increase in 2D+PW mode or 2D+CDI (POWER; ADF) +PW mode. When the system is used under both conditions listed below; the temperature of the transducer head connected to the system may increase in temperature and possibly
Integra Limited Oct-30-2013 Integra¿ Camino 110-4 Intracranial Pressure (ICP) Monitoring – Brand Names: Integra¿ Camino 110-4 Intracranial Pressure (ICP) MonitoringCatheters.Product / Catalogue No.s: 110-4B; 110-4BC; 110-4G; 110-4H; 110-4HC; 110-4L; 110-4LC.The fully packaged 110-4B; 110-4H; and 110-4L catheters arealso provided as a component in kits that contain other cranialaccess devices. These kits are Catalogue No. 110-4BC; 110-4HC; and 110-4LC respectively.Common Name: Intracranial Pressure and Pressure-Temperature Monitoring KitsClassification Name: Device; Monitoring; Intracranial Pressure510(k) Number: K102875The Camino 110-4 Intracranial Pressure monitoring catheters are sterile transducer-tipped pressure monitoring catheters that are used by neurosurgeons to rapidly determine and continuously monitor intracranial pressure or pressure/temperature. The Camino 110-4B catheter is used for Intracranial Pressure Monitoring in the parenchyma or subarachnoid space. The Camino 110-4G catheter is used for Post Craniotomy Subdural Pressure Monitoring. The Camino 110-4H catheter is intended for Intracranial Pressure Monitoring and Cerebrospinal fluid drainage. The Camino 110-4L catheter is intended for use with the Licox¿ Brain Oxygen Monitoring System to measure intracranial pressure in the parenchyma. The fully packaged 110-4B; 110-4H; and 110-4L catheters are also provided as a component in kits that contain other cranial access devices. These kits are Catalogue No. 110-4BC; 110- 4HC; and 110-4LC respectively. Integra LifeSciences has identified through an internal evaluation that in order to comply with US FDArequirements; certain Camino? Intracranial Pressure Monitoring Kits require additional labelling to indicatethey are UNSAFE in an MR environment.Only the following Camino? Intracranial Pressure Monitoring Kits are affected:110-4B; 110-4BC; 110-4G; 110-4H; 110-4HC; 110-4L; 110-4LC.
Toshiba American Medical Systems Inc Oct-30-2013 Aplio MX Diagnostic Ultrasound System SSA-780A – Aplio MX Diagnostic Ultrasound System SSA-780AUsed for routine diagnostic imaging The firm initiated this recall of certain Toshiba Diagnostic Ultrasound Systems because it has been found that under certain conditions; the temperature of the transducer head may increase in 2D+PW mode or 2D+CDI (POWER; ADF) +PW mode. When the system is used under both conditions listed below; the temperature of the transducer head connected to the system may increase in temperature and possibly