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Showing 17421–17440 of 22534 results

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Siemens Medical Solutions USA, Inc: Impression Therapist 3rd party V&R equipped with a Cohere...

Flat panel positioning calibration could be off by as much as 4 mm without the machine discovering detail.

FDANov 6, 2007Nationwide• Siemens Medical Solutions USA, Inc

Siemens Medical Solutions USA, Inc: Coherence Therapist 2.0 equipped with a Coherence Therapi...

Flat panel positioning calibration could be off by as much as 4 mm without the machine discovering detail.

FDANov 6, 2007Nationwide• Siemens Medical Solutions USA, Inc

Siemens Medical Solutions USA, Inc: Coherence Therapist System 2.1 equipped with a Coherence ...

Flat panel positioning calibration could be off by as much as 4 mm without the machine discovering detail.

FDANov 6, 2007Nationwide• Siemens Medical Solutions USA, Inc

Siemens Medical Solutions USA, Inc: Syngo Based WS for 3rd party equipped with a Coherence Th...

Flat panel positioning calibration could be off by as much as 4 mm without the machine discovering detail.

FDANov 6, 2007Nationwide• Siemens Medical Solutions USA, Inc

Siemens Medical Solutions USA, Inc: PRIMEVIEW 3i System 2.1 equipped with a Coherence Therapi...

Flat panel positioning calibration could be off by as much as 4 mm without the machine discovering detail.

FDANov 6, 2007Nationwide• Siemens Medical Solutions USA, Inc

Siemens Medical Solutions USA, Inc: PRIMEVIEW 3i System equipped with a Coherence Therapist ...

Flat panel positioning calibration could be off by as much as 4 mm without the machine discovering detail.

FDANov 6, 2007Nationwide• Siemens Medical Solutions USA, Inc

Siemens Medical Solutions USA, Inc: PRIMEVIEW 3i System 2.0 equipped with a Coherence Therapi...

Flat panel positioning calibration could be off by as much as 4 mm without the machine discovering detail.

FDANov 6, 2007Nationwide• Siemens Medical Solutions USA, Inc

bioMerieux, Inc.: bioMerieux, BacT/ALERT FA Culture Bottles, bioMerieux, In...

Duplicate Bottle Indentification -- Three lot numbers of BacT/ALERT FA Culture Bottles labels contained duplicate bottle identification (Bottle ID) barcode numbers. (Lots 1017685 and 1017788 contain the same series of Bottle ID's; Lot 1017693 contains duplicate Bottle ID's within the lot and may share Bottle ID's with both lots 1017685 and 1017788)

FDANov 5, 2007Nationwide• bioMerieux, Inc.

Siemens Medical Solutions USA, Inc: Magnetom Espree with Swiveling OR (Operating Room) Table,...

Table may experience a deadlock situation

FDANov 5, 2007IN, NY, TX• Siemens Medical Solutions USA, Inc

Sonosite, Inc.: SLT transducer is used on the SonoSite MicroMaxx ultrasou...

Sterilization of the SonoSite SLT ultrasound surgical transducer with the Sterrad NX System may result in damage to the transducer.

FDANov 2, 2007Nationwide• Sonosite, Inc.

Sonosite, Inc.: Laparoscopic Ultrasound Transducer (LAP Transducer) is us...

Sterilization of the SonoSite LAP surgical Transducer with the Sterrad NX System may result in damage to the transducer.

FDANov 2, 2007Nationwide• Sonosite, Inc.

Stryker Howmedica Osteonics Corp.: Stryker LFIT COCR V40 Femoral Head; xx-Long (+16mm) Neck ...

Fracture of Stem Neck - The firm recently performed laboratory testing indicates that there may be a potential increased risk of stem neck fractures when a V40 +16mm offset femoral head is mated with certain Accolade TMZF femoral stems in patients classified as overweight or obese.

FDANov 2, 2007Nationwide• Stryker Howmedica Osteonics Corp.

Stryker Medical Div. of Stryker Corporation: Stryker inTouch Zoom Critical Care bed, Model 2140, Stryk...

Multiple defects: 1) beds exhibit reverse motions when the Fowler, gatch or foot section is activated 2) a battery charging defect which may result in a depletion of battery power 3) the touch screen on the footboard freezing, resulting in controls to powered, pressure-relief mattresses being difficult to access 4) beds equipped with zoom drive systems may have an overdrive problem which could re

FDANov 2, 2007Nationwide• Stryker Medical Div. of Stryker Corporation

Nova Biomedical Corporation: Nova - EZ CHEM Linearity Solution P/N 9618, Nova Biomedic...

Incorrect Results - Creatinine results were lower than the laboratory reference method.

FDANov 2, 2007Nationwide• Nova Biomedical Corporation

Nova Biomedical Corporation: Nova - EZ CHEM Control Solution P/N 9612, Nova Biomedical...

Incorrect Results - Creatinine results were lower than the laboratory reference method.

FDANov 2, 2007Nationwide• Nova Biomedical Corporation

Nobel Biocare USA LLC: NobelReplace Tapered Groovy RP 4.3x10mm. These products ...

This recall was initiated after it was discovered that the NobelReplace Tapered Groovy RP 4.3x10mm, REF 32216 Lot#403504 has an incorrect cap label. The affected lot has a cap label identifying the implant as "4.3x8". Since this cap label may be the only means used for identifying the implant prior to surgery, it is possible that a user would try to use the 10mm implant as an 8mm implant.

FDANov 2, 2007AZ, AR, CA +18 more• Nobel Biocare USA LLC

Stryker Howmedica Osteonics Corp.: Stryker COCR V40 Femoral Head; xx-Long (+16mm) Neck Lengt...

Fracture of Stem Neck - The firm recently performed laboratory testing indicates that there may be a potential increased risk of stem neck fractures when a V40 +16mm offset femoral head is mated with certain Accolade TMZF femoral stems in patients classified as overweight or obese.

FDANov 2, 2007Nationwide• Stryker Howmedica Osteonics Corp.

ConMed Electrosurgery: Conmed Accessory Electrode, Universal Electrodes, Part/...

Sterility (package integrity) Compromised: packages of the electrosurgical blades and needles have an inadequate packaging seal

FDANov 2, 2007Nationwide• ConMed Electrosurgery

Nova Biomedical Corporation: Nova - EZ CHEM Creatinine Meter: SRS Versions 5.1 and 5.2...

Incorrect Results - Creatinine results were lower than the laboratory reference method.

FDANov 2, 2007Nationwide• Nova Biomedical Corporation

Stryker Howmedica Osteonics Corp.: Stryker Trial Head xx-Long (+16mm) Neck Length 26mm Diame...

Fracture of Stem Neck - The firm recently performed laboratory testing indicates that there may be a potential increased risk of stem neck fractures when a V40 +16mm offset femoral head is mated with certain Accolade TMZF femoral stems in patients classified as overweight or obese.

FDANov 2, 2007Nationwide• Stryker Howmedica Osteonics Corp.

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