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Showing 17701–17720 of 22534 results

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Warsaw Orthopedic, Inc. dba Medtronic SOFAMOR DANEK: Medtronic Sofamor Danek METRx (TM) System Bayonet Electro...

Packaging weakness may compromise sterility and instructions for use are inadequate.

FDASep 4, 2007Nationwide• Warsaw Orthopedic, Inc. dba Medtronic SOFAMOR DANEK

OrthoHelix Surgical Designs Inc: DRL System Trays comprised of DRLock Bone Fixation Plate...

Seat/Fit problems: The heads of the distal screws/pegs rest above the surface of the distal plate after the screws/pegs are fully tightened.

FDASep 4, 2007Nationwide• OrthoHelix Surgical Designs Inc

GE Healthcare Clinical Systems: GE LOGIQ 3 Expert ultrasound scanner with software versio...

Inaccurate guidelines: The BE9C is an optional, small radius Bi-planar convex probe intended for use with the LOGIQ 3 Expert system in Urology application. An attempt by the user to activate the biopsy guidelines while this probe is in use will cause incorrect guidelines to be displayed on the image. The incorrect guidelines are recognized by their orientation that is left/right reversed from t

FDASep 4, 2007AL, NY• GE Healthcare Clinical Systems

Exocomm Tech Grp: life+cel Replacement Battery for Cardiac Science Powerhea...

Marketed without a 510K

FDASep 3, 2007CT, GA, IN +8 more• Exocomm Tech Grp

Biomet, Inc.: Biomet Orthopedics, Vanguard PS Open Box Femoral, 67.5 mm...

Mislabeled as to size; labeled as 67.5 mm, actually contains 62.5 mm size femoral component.

FDAAug 31, 2007Nationwide• Biomet, Inc.

Metrika Inc: A1CNOW+ with sampler 10-Test Kits (Product No: 3022), Me...

Incorrect Test Results: Due to manufacturing errors regarding temperature compensation factors, the device will give erroneously high results if the test is performed below 70 degrees Fahrenheit.

FDAAug 31, 2007Nationwide• Metrika Inc

Cardinal Health 303 Inc DBA Alaris Products: Texium Closed Male Luer (CML), Model Number 10012241, Ca...

Leaks: there is a risk of leakage at the female end of the Texium closed male luer (CML) when attached to a spin luer. (NOTE: users who connect the female portion of the Texium closed male luer to fixed (one-piece) male luers on tubing or on syringes are not affected by this issue)

FDAAug 30, 2007AR, CA, CO +22 more• Cardinal Health 303 Inc DBA Alaris Products

Stryker Howmedica Osteonics Corp.: Trident PSL HA Cluster Acetabular Shell; Arc Deposited HA...

Stryker Orthopaedics had identified that specific lots of Trident PSL Acetabular shells may have a dimensional discrepancy. The deviation regarding the difference in wall thickness will increase the gap between the shell and liner on one side and will decrease the gap between shell and liner on the opposing side, resulting in interference.

FDAAug 30, 2007Nationwide• Stryker Howmedica Osteonics Corp.

Stryker Howmedica Osteonics Corp.: HA Solid Back Acetabular Shell; Arc Deposited HA Coated I...

Stryker Orthopaedics had identified that specific lots of Trident PSL Acetabular shells may have a dimensional discrepancy. The deviation regarding the difference in wall thickness will increase the gap between the shell and liner on one side and will decrease the gap between shell and liner on the opposing side, resulting in interference.

FDAAug 30, 2007Nationwide• Stryker Howmedica Osteonics Corp.

Roche Diagnostics Corp.: Roche Diagnostics LightCycler Capillaries (100uL) for use...

False Negative Results: Air bubbles in the lens or the area surrounding the lens of the LightCycler 100 uL capillaries may cause false negative results. The affected capillaries showed up to a 40% reduction in signal

FDAAug 30, 2007Nationwide• Roche Diagnostics Corp.

Beckman Coulter Inc: Vidiera NsP Nucleic Sample Preparation, Part Number: A224...

Incorrect results: under certain circumstances, when transfer volume is not within the set range, the Vidiera NsP software does not report sample exclusion and does not flag the excluded sample in the "Run Results" report. The software error associated with the excluded sample appears as "Liquid was not successfully transferred to well#..........the sample will be excluded from further proce

FDAAug 30, 2007Nationwide• Beckman Coulter Inc

Toshiba American Med Sys Inc: NEMIO XG Ultrasound System, Model SSA-580A , Software ver...

Multiple problems including : (1) The surface temperature of the transducer tip can rise and exceed the limit set by the international standard. (2) Incorrect display of the TI indices on the display monitor. The displayed value is greater or smaller than the true TI value, and (3) Manuals contain incorrect values for MI/TI values.

FDAAug 29, 2007Nationwide• Toshiba American Med Sys Inc

Medtronic, Inc.: Medtronic Export XT Aspiration Catheter, 6F (US) Medtroni...

Additional Warning in Instructions for Use for guide wire management. Complaints of wire lumen tearing during use or band marker becoming dislodged.

FDAAug 29, 2007Nationwide• Medtronic, Inc.

Toshiba American Med Sys Inc: NEMIO Ultrasound System, Model SSA-550A , Software versi...

Multiple problems including : (1) The surface temperature of the transducer tip can rise and exceed the limit set by the international standard. (2) Incorrect display of the TI indices on the display monitor. The displayed value is greater or smaller than the true TI value, and (3) Manuals contain incorrect values for MI/TI values.

FDAAug 29, 2007Nationwide• Toshiba American Med Sys Inc

Invacare Corporation: Mattress Model 5185 and 5185XL. Manufactured by: Invac...

In September 2007 Invacare Corporation recalled the innerspring mattresses associated with Invacare's IVC Bed Series Full Electric Beds, Semi-Electric Beds and Manual Beds and the ValueCare Bed Series Semi Electric Bed. These mattresses were manufactured between June 28, 2007 and July 12, 2007. These mattresses when used in combination with the IVC and ValueCare Series of manual, semi-electric a

FDAAug 29, 2007Nationwide• Invacare Corporation

Boston Scientific Corporation: Boston Scientific Radial Jaw Large Capacity Biopsy Forcep...

Device lacked manufacturing finishing process resulting in endoscope damage.

FDAAug 28, 2007Nationwide• Boston Scientific Corporation

Medtronic Inc. Cardiac Rhythm Managment: Medtronic Paceart System, 2006 Edition, Medtronic, Inc. 7...

An issue with the Paceart System - 2006 First Edition (Get Connected Edition) exists. Under certain circumstances, Paceart System Generic ICD reports may not accurately reflect patient VT/VF, SVT/NST and Mode Switch/AT/AF episode detection data. When episode detection data is imported into the Paceart System from certain sources, the Paceart System Generic ICD reports display a zero, suggesting

FDAAug 27, 2007Nationwide• Medtronic Inc. Cardiac Rhythm Managment

Medtronic Sofamor Danek USA Inc: Medtronic Sofamor Danek, TSRH SiLo 5.5 Spinal System, Sag...

Disassembly: The movable cradle component could detach from the saddle under extreme manipulation of the associated rods prior to final tightening of the set screws.

FDAAug 24, 2007Nationwide• Medtronic Sofamor Danek USA Inc

Mallinckrodt Inc: Angiomat Illumena Injector with Auxiliary Console, Mallin...

Synchronization problems: units that have both a main programmable console and an auxiliary programmable console, when simultaneously, injection parameters are programmed into the unit's main console and the unit's auxiliary consoles, mis-synchronization could occur resulting in a variance between the intended injection parameters (those programmed) and the actual parameters of the injection deliv

FDAAug 24, 2007AL, AZ, CA +27 more• Mallinckrodt Inc

BatteryZone, Inc.: life+cel, Replacement Battery for Cardiac Science Powerhe...

Marketed without 510 (K) approval

FDAAug 24, 2007Nationwide• BatteryZone, Inc.

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