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Showing 18201–18220 of 22584 results

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C P Medical: Product is an EO Sterile, Polydioxanone Violet monofilame...

Potential for sterility of product to be compromised. Suture package seals incomplete or missing.

FDAApr 3, 2007Nationwide• C P Medical

C P Medical: Product is an EO Sterile, Polyester braided and coated no...

Potential for sterility of product to be compromised. Suture package seals incomplete or missing.

FDAApr 3, 2007Nationwide• C P Medical

Rita Medical Systems, Inc.: RITA Starburst XL (3-5 cm Diameter/25cm Length), Electro-...

The product may have a cracked tray which can compromise the sterility of the product.

FDAApr 3, 2007Nationwide• Rita Medical Systems, Inc.

Unknown Manufacturer: Lumex Walkabout Lite Four-Wheel Rollator, Manufactured fo...

The caster bolt stem/screw may loosen over time causing the wheel to come off.

FDAApr 2, 2007Nationwide

GE OEC Medical Systems, Inc: Radiological Image Processing System The system is an ai...

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.

FDAApr 2, 2007FL, IL, IN +6 more• GE OEC Medical Systems, Inc

Ethicon Endo-Surgery Inc: Proximate PPH, Procedure for Prolapse and Hemmorroids Set...

Fire/Burn Risk

The adhesive used to bond the casing of the device may have migrated to the staple driver. While the device still fires, it may result in audible and tactile feedback at the midpoint of the firing cycle which may be interpreted by some surgeons as a completed firing cycle, which may cause the surgeon to prematurely stop firing the device and result in incomplete staple formation or cut line.

FDAApr 2, 2007Nationwide• Ethicon Endo-Surgery Inc

Ossur Grjothals 5 Reykjavik Ireland: Ossur Total Knee Model Number 2100, external knee prosthe...

Some units of the Total Knee Model 2100 produced from August 1, 2006 through October 4, 2006 may contain a faulty linkage component.

FDAApr 2, 2007Nationwide• Ossur Grjothals 5 Reykjavik Ireland

Volcano Corporation: Volcano s5 Imaging system, Ultrasound pulsed echo imaging...

During emissions testing, it was discovered that the product exceeds emissions limits for electromagnetic compatibility.

FDAApr 2, 2007Nationwide• Volcano Corporation

Diopsys, Inc.: Diopsys Inc., Enfant Pediatric VEP Vision Testing System,...

The computer based system may lose test counts when the time in the device was changed during a changeover from standard time to daylight savings time in March 2007.

FDAApr 2, 2007Nationwide• Diopsys, Inc.

Wako Chemicals USA, Inc.: NEFA Standard Solution Calibrator, Oleic Acid, 1 mmol/L, ...

Diagnostic reagent for clinical laboratory testing was incorrectly labeled.

FDAMar 30, 2007Nationwide• Wako Chemicals USA, Inc.

Intuitive Surgical, Inc.: Intuitive Surgical, daVinci S Surgical System, Model Numb...

System Lock-Up: Software anomalies could cause product failure during use, or on start-up. System transitions to a safe "soft-lock" state.

FDAMar 30, 2007Nationwide• Intuitive Surgical, Inc.

Medtronic Emergency Response Systems, Inc.: Batteries used with the LIFEPAK 20 defibrillator/monitor

Defibrillator internal battery cell may contain a short which could reduce battery capacity and cause the device to shut down without warning while operating on backup (DC) battery power.

FDAMar 30, 2007IN• Medtronic Emergency Response Systems, Inc.

Abbott Diagnostic International, Ltd. 30 Bo Cruce Davila: Abbott AxSYM System Digoxin III Reagent Pack

Customers are receiving error codes (1062, 1063, 1113, & 1118) when running patient samples on the AxSYM Digoxin III assay.

FDAMar 30, 2007PR• Abbott Diagnostic International, Ltd. 30 Bo Cruce Davila

Lifescan Inc: One Touch SureSoft Lancing Device in carton. Part Number...

Lancet tip may not fully retract and cause needle stick and exposure to used lancets.

FDAMar 30, 2007Nationwide• Lifescan Inc

Siemens Medical Solutions USA, Inc: Magnetom Espree System with OR Table

If table top is not seated properly it can lock up/stick.

FDAMar 30, 2007IN, NY, TX• Siemens Medical Solutions USA, Inc

Thoratec Corp: Thoratec Paracorporeal Ventricular Assist Device (PVAD) c...

Incorrect collect nut assembly (inadvertent use of the incorrect (Black) collect nut) during surgical implantation (wrong size collect nut) to secure the inflow cannula to the PVAD has resulted in patient deaths

FDAMar 30, 2007Nationwide• Thoratec Corp

Diagnostica Stago, Inc.: STA Neoplastine CI Plus (10), (cat. 0667). 12 x 10 ml. i...

Based on the confirmed clotting times in the upper part of the assigned ranges of STA-Coag Control ABN control plasmas when used with STA-Neoplastine CI Plus, use of this lot may cause difficulty during the validation of the STA-Coag Control ABN.

FDAMar 30, 2007Nationwide• Diagnostica Stago, Inc.

Medtronic Emergency Response Systems, Inc.: LIFEPAK 20 defibrillator/monitor. The device is an AC po...

Defibrillator internal battery cell may contain a short which could reduce battery capacity and cause the device to shut down without warning while operating on backup (DC) battery power.

FDAMar 30, 2007IN• Medtronic Emergency Response Systems, Inc.

Hamilton Co: Microlab F.A.M.E. reagent containers, Part number 148482,...

Some product containers may be leaking.

FDAMar 29, 2007IN, NJ, TX +1 more• Hamilton Co

GE Healthcare: GE Healthcare Proteus XR/a Eclipse Collimator model # 237...

The actual average illuminance for the collimators are approximately 140-lux. This does not meet the 160-lux requirement. GE will be correcting the units by replacing all collimators.

FDAMar 29, 2007CA, DE, FL +20 more• GE Healthcare

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