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Showing 63001–63020 of 68218 results

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Siemens Medical Solutions USA, Inc: Siemens Magnetom Harmony Mobile MRI System. Model Number:...

Magnet Quench, unintended- magnet of a mobile MRI system quenched into the exam room.

FDADec 1, 2007Nationwide• Siemens Medical Solutions USA, Inc

Siemens Medical Solutions USA, Inc: Siemens Magentom Symphony, Model Number: 4760265, Siemens...

Magnet Quench, unintended- magnet of a mobile MRI system quenched into the exam room.

FDADec 1, 2007Nationwide• Siemens Medical Solutions USA, Inc

Siemens Medical Solutions USA, Inc: Siemens Magentom Symphony syngo Upgrade, Model Number: 7...

Magnet Quench, unintended- magnet of a mobile MRI system quenched into the exam room.

FDADec 1, 2007Nationwide• Siemens Medical Solutions USA, Inc

Siemens Medical Solutions USA, Inc: Siemens Magnetom Symphony syngo, Model Number: 7104594, S...

Magnet Quench, unintended- magnet of a mobile MRI system quenched into the exam room.

FDADec 1, 2007Nationwide• Siemens Medical Solutions USA, Inc

Becton Dickinson & Co.: Lee Laboratories brand Shigella Antiserum Poly Group B, c...

In vitro diagnostic test reagent for identification of Shigella bacteria in patient samples may cause false negative results.

FDANov 30, 2007Nationwide• Becton Dickinson & Co.

Boston Scientific Corporation: Pathway Balloon Expandable Ureteral Access Sheath- 11/14/...

Sheath Removal Difficulty: Users experience difficulty in removing the sheath.

FDANov 30, 2007Nationwide• Boston Scientific Corporation

Becton Dickinson & Co.: Difco(tm) Shigella Antiserum Poly Group B, Catalog # 2283...

In vitro diagnostic test reagent for identification of Shigella bacteria in patient samples may cause false negative results.

FDANov 30, 2007Nationwide• Becton Dickinson & Co.

Sakar International, Inc.: Maximo Concepts Alcohol Breath Tester, Model Number: MAX9...

Marketed without a 510(k)

FDANov 30, 2007Nationwide• Sakar International, Inc.

Computerized Medical Systems Inc: Focal Radiation Treatment Planning System, Focal Release...

Focal: when a plan is sent to Focal from XiO and the structure properties are edited in Focal CT Sim activity, these changes result in changes to the MLC or field size for the plan when they should not. XiO will recalculate dose when modified plan is returned to XiO however the user may not notice that it has changed form the plant they had approved earlier. Editing the structure properties (col

FDANov 30, 2007Nationwide• Computerized Medical Systems Inc

Philips Medical Systems North America Co. Phillips: MultiDiagnost Eleva Flat Detector X-Ray System; Part Numb...

Delay in Imaging: MultiDiagnost Eleva with Flat Detector x-ray system cannot perform fluoroscopy procedures while certain image file housekeeping operations are performed. Fluoroscopy cannot be performed and new exposures are not able to be acquired until the housekeeping operations are complete which may take several minutes. The loss of system availability could occur during an interventional

FDANov 29, 2007CO, MN, NJ +2 more• Philips Medical Systems North America Co. Phillips

Baxter Healthcare Corp. Rt.: Baxter Single Day INFUSOR Portable Elastomeric Infusion S...

Leaking: leaks at the tubing flow restrictor connection to either the coupler or the male luer during filling.

FDANov 29, 2007Nationwide• Baxter Healthcare Corp. Rt.

Marknew Products: HAENG LIM --Acupunture Needles- PRE-STERILIZED GAMMA-RAY;...

Marketed without 510(k)

FDANov 28, 2007Nationwide• Marknew Products

Invacare Corporation: Invacare Storm TDX SP Power Wheelchair with Stability Loc...

Invacare has become aware that on some chairs, the stability lock feature may not be engaging properly or consistently. If the stability lock feature does not engage properly, the wheelchair may veer to one side or it may rock forward onto its front riggings.

FDANov 27, 2007Nationwide• Invacare Corporation

Medtronic Navigation, Inc: Medtronic O-Arm Intraoperative Imaging System Catalog Nu...

Navigation accuracy problem: Accuracy may fall outside of specification when used in combination with the Medtronic Synergy Experience StealthStation System Spine Software with the O-Arm Intraoperative Imaging System and tracker.

FDANov 27, 2007Nationwide• Medtronic Navigation, Inc

Siemens Medical Solutions USA, Inc: Siemens Syngo Imaging System with VB30A version of softwa...

Inconsistent data - A buffer overflow may occur between information system and picture system if the system experiences a high load. (e.g. RIS/PACS communication is unusally high)

FDANov 27, 2007Nationwide• Siemens Medical Solutions USA, Inc

Allen Medical Systems, Inc. One Post Office Square: Allen Medical C-Flex, Polar Head Positioner Catalog Numbe...

Handle jamming in the open position, preventing the device from adequately supporting the head during spinal surgery. Possible delay in surgery, or injury.

FDANov 27, 2007MA, MS• Allen Medical Systems, Inc. One Post Office Square

Invictus Scientific Inc: Invictus-- Bionime Rightest Blood Glucose Monitoring Syst...

Abnormal Memory Recall: When the meter is fixed in 12 hour mode, the time frame display of all memory data will be shown incorrectly as AM or PM depending on when the user is recalling the memory stored in the meter. This will cause confusion as to when the last test was taken.

FDANov 26, 2007Nationwide• Invictus Scientific Inc

Tenet Medical Engineering Inc 11979 40th St Se /#203 Ab Calgary Canada: TENET Medical Engineering Wrist Stabilization Kit, Small;...

Sterility compromised: Sterility seals on some of the firm's wrist stabilization kit pouches may be compromised.

FDANov 23, 2007Nationwide• Tenet Medical Engineering Inc 11979 40th St Se /#203 Ab Calgary Canada

Smith And Nephew, Inc. Wound Management Division: Smith & Nephew, Inc., Exu-Dry Wound Burn Dressing, Produc...

Sterility (package integrity) compromised: Distribution of product that did not meet specifications; open seals.

FDANov 21, 2007Nationwide• Smith And Nephew, Inc. Wound Management Division

Medtronic Cardiac Surgery Technologies: Medtronic Cardioblate Gemini-s, model 49260. Surgical Ab...

Mechanism failure: Medtronic has identified an issue with four lots of the Cardioblate Gemini-s Surgical Ablation Devices in which the polycarbonate distal coil retainer can fail during the course of a procedure, potentially resulting in an inability to apply the necessary jaw closure force.

FDANov 21, 2007Nationwide• Medtronic Cardiac Surgery Technologies

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