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Showing 65781–65800 of 68218 results

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Siemens Medical Solutions USA, Inc: Magnetom Avanto. Magnetic Resonance Imaging System. Model...

there is a misalignment of the patient table that may occur between the patient table and the opening to the magnet bore

FDAAug 12, 2005Nationwide• Siemens Medical Solutions USA, Inc

Stryker Howmedica Osteonics Corp.: T2 Recon Nail System.

The blister pack containing the Recon 6.5 Lag Screws may become damage during shipment resulting in loss of sterility.

FDAAug 12, 2005Nationwide• Stryker Howmedica Osteonics Corp.

Stryker Howmedica Osteonics Corp.: Scorpio Total Knee Cruciate Retaining Femoral Component, ...

The Left Scorpio Total Knee Cruciate Retaining Waffle Femoral Component #7 packaged and labeled as left may contain a Right and vice versa.

FDAAug 11, 2005Nationwide• Stryker Howmedica Osteonics Corp.

Boston Scientific Corporation One Boston: Renegade Hi-Flo Microcatheter Kits, Catalog/Order # 18-29...

Outer box of the product may have an incorrect expiration date listed as 2007-06, while the correct expiration date is 2007-04

FDAAug 10, 2005KY, TX• Boston Scientific Corporation One Boston

Beckman Coulter Inc: Aqueduct Hematology Workflow Manager, software

Potentail for misidentification of historical patient results within the Aqueduct Hematology Workflow Manager software. In instances where the workflow manager software receives the same patient identifier for more than one patient the Aqueduct Workflow Manager software merges all results into one Patient File. The may cause test results to be associated with the wrong patient.

FDAAug 10, 2005AK, AZ, CA +15 more• Beckman Coulter Inc

Pascal Co Inc: product labeled in part: ''***banicide ADVANCED, A Reusa...

The product, Banicide Advanced, a resuable sterilizing and disinfecting solution, is likely to be ineffective for its intended use because testing found it failed testing for sporicidal use.

FDAAug 9, 2005Nationwide• Pascal Co Inc

Depuy Mitek, a Johnson & Johnson Co.: DePuy Mitek Straightshot Ligament Graft Passer/Protector,...

Mislabeled: The kit contained the incorrect Ligament Passer. The package contained a 9.5 mm instead of the labeled 11.5mm ligament passer

FDAAug 9, 2005CA, NC, VA• Depuy Mitek, a Johnson & Johnson Co.

Trek Diagnostic Systems: VersaTREK Myco AS.

Invitro diagnostic test kit used for testing to confirm the presence of tuberculosis contains interfering bioburden which can cause false positive results.

FDAAug 8, 2005AL, IL, IN +6 more• Trek Diagnostic Systems

Stryker Howmedica Osteonics Corp.: Reamer T-Handle; Non- Sterile; Howmedica Osteonics Corp.,...

Stryker Orthopaedics learned that the T-handles have the potential to not engage and not attach to the reamer properly.

FDAAug 8, 2005Nationwide• Stryker Howmedica Osteonics Corp.

Diasorin Inc.: The ETI-Mumps IgG Enzyme Immunoassay Test Kit is sold wit...

Potential for false negative results. A software anomaly may occur when performing the ETI-Mumps IgG assay on the ETI-Max 3000 automated platform. The error occurs when running a combined plate on the ETI-Max 3000, with the ETI-Mumps IgG assay as the second assay on a combined plate with ETI-Measles IgG and/or ETI-VZV IgG.

FDAAug 8, 2005Nationwide• Diasorin Inc.

Stryker Howmedica Osteonics Corp.: Navigation Reamer T-handle; Non Sterile; Howmedica Osteon...

Stryker Orthopaedics learned that the T-handles have the potential to not engage and not attach to the reamer properly.

FDAAug 8, 2005Nationwide• Stryker Howmedica Osteonics Corp.

Biosense Webster, Inc.: Thermocool Irrigated Catheters Celsius LABEL US Part Num...

Increased complaints regarding catheters with leaks and flow obstruction.

FDAAug 8, 2005FL, IL, MA +3 more• Biosense Webster, Inc.

Guidant Endovascular Solutions, Inc.: Guidant OTW OMNILINK .018 & .035 Biliary Stent Systems

This action is being taken as a preventative measure as a result of an increased rate of complaints associated with stents becoming loose or dislodged from the delivery catheter.

FDAAug 8, 2005Nationwide• Guidant Endovascular Solutions, Inc.

Abbott Laboratories MPG: ABBOTT TestPack +Plus hCG Combo, list 3A60-16; the kit co...

False Positive results may be obtained with the identified lot of list 3A60-16 when using a negative patient sample or a negative control.

FDAAug 7, 2005IN• Abbott Laboratories MPG

Boston Scientific Scimed: Stainless Steel Greenfield Vena Cava Filter with 12 Fr. /...

Certain units within eleven lots of the 12 Fr Greenfield Vena Cava Filter may lack a taper on the braided sheath of the delivery system. The lack of a taper could lead to vessel damage as a result of the sheath catching on the edge of the vein and causing a tear.

FDAAug 5, 2005AL, AK, AZ +31 more• Boston Scientific Scimed

Datex Ohmeda, Inc. dba GE Healthcare: Ohmeda Giraffe SPOT PT Lite Phototherapy System

Phototherapy medical device may lose its position and can cause a safety hazard to the patient.

FDAAug 5, 2005IN• Datex Ohmeda, Inc. dba GE Healthcare

Boston Scientific Scimed: Titanium Greenfield Vena Cava Filter with 12 Fr./4,0 mm ...

Certain units within eleven lots of the 12 Fr Greenfield Vena Cava Filter may lack a taper on the braided sheath of the delivery system. The lack of a taper could lead to vessel damage as a result of the sheath catching on the edge of the vein and causing a tear.

FDAAug 5, 2005AL, AK, AZ +31 more• Boston Scientific Scimed

Stryker Instruments Div. of Stryker Corporation: Stryker brand Consolidated Operating Room Equipment (CORE...

Potential electrical shock hazard, in that the potential exists for the patient to be exposed to an earth-referenced electrical current.

FDAAug 5, 2005VA• Stryker Instruments Div. of Stryker Corporation

Abbott Laboratories Diagnostic Div: Abbott Clinical Chemistry Bilirubin Calibrator, List # 1E...

The product issue is that the value sheet for the Clinical Chemistry Bilirubin Calibrator, lot #20881M100 calibrator value sheet, has the calibrator values transposed for the Total Bilirubin Assay LN 7D60, Total Bilirubin Assay LN 8G62, and Neonatal Bilirubin Assay LN 9D88.

FDAAug 5, 2005Nationwide• Abbott Laboratories Diagnostic Div

Skytron, Div. The KMW Group, Inc: Skytron General Purpose Surgical Table; Model 6600, Dist....

The release levers can inadvertently release under load while the leg section is positioned at a ninety degree angle causing the leg section to drop.

FDAAug 4, 2005Nationwide• Skytron, Div. The KMW Group, Inc

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