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Showing 18261–18280 of 22584 results

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Philips Medical Systems North America Co. Phillips: Practix 300 Mobile X-ray systems. The systems are used i...

X-ray systems lack product report certification demonstrating compliance, and were illegally introduced into the United States commerce.

FDAMar 23, 2007Nationwide• Philips Medical Systems North America Co. Phillips

Siemens Medical Solutions USA, Inc: Siemens, ONCOR Avante Garde, Part No.: 58 63 472,Medical ...

Product's collision detection system may not be sensitive enough to trigger a stop action without a significant amount of force.

FDAMar 23, 2007AL, AK, AR +29 more• Siemens Medical Solutions USA, Inc

Philips Medical Systems North America Co. Phillips: Practix 160 Mobile X-ray systems. The systems are used i...

X-ray systems lack product report certification demonstrating compliance, and were illegally introduced into the United States commerce.

FDAMar 23, 2007Nationwide• Philips Medical Systems North America Co. Phillips

Siemens Medical Solutions USA, Inc: MEVATRON MDX-2,Medical charge-particle radiation therapy ...

Mistreatment of radiation therapy due to inadvertent parameter changes or miss-calibration in Service Mode. The miss-calibration can affect the beam profile and Virtual Wedge angle. This leads to patient mistreatment and alteration of future treatment plans. A second reason is an unplanned Dosimetry calibration data set can be erroneously copied during "Service Mode."

FDAMar 22, 2007AL, AK, AZ +43 more• Siemens Medical Solutions USA, Inc

Siemens Medical Solutions USA, Inc: PRIMUS Plus,Medical charge-particle radiation therapy sys...

Mistreatment of radiation therapy due to inadvertent parameter changes or miss-calibration in Service Mode. The miss-calibration can affect the beam profile and Virtual Wedge angle. This leads to patient mistreatment and alteration of future treatment plans. A second reason is an unplanned Dosimetry calibration data set can be erroneously copied during "Service Mode."

FDAMar 22, 2007AL, AK, AZ +43 more• Siemens Medical Solutions USA, Inc

Siemens Medical Solutions USA, Inc: MEVATRON KD-2,Medical charge-particle radiation therapy s...

Mistreatment of radiation therapy due to inadvertent parameter changes or miss-calibration in Service Mode. The miss-calibration can affect the beam profile and Virtual Wedge angle. This leads to patient mistreatment and alteration of future treatment plans. A second reason is an unplanned Dosimetry calibration data set can be erroneously copied during "Service Mode."

FDAMar 22, 2007AL, AK, AZ +43 more• Siemens Medical Solutions USA, Inc

Unknown Manufacturer: Reverse Shoulder Prosthesis (RSP) custom device component...

Marketed without approval: Investigational devices were implanted during an IDE study prior to receiving approval for the devices in the study; patients were implanted with investigational devices outside of the IDE study; and devices implanted as "custom devices" by the manufacturer did not meet the definition of "custom devices" and were, therefore, unapproved devices.

FDAMar 22, 2007Nationwide

Siemens Medical Solutions USA, Inc: MEVATRON M-2 6300,Medical charge-particle radiation thera...

Mistreatment of radiation therapy due to inadvertent parameter changes or miss-calibration in Service Mode. The miss-calibration can affect the beam profile and Virtual Wedge angle. This leads to patient mistreatment and alteration of future treatment plans. A second reason is an unplanned Dosimetry calibration data set can be erroneously copied during "Service Mode."

FDAMar 22, 2007AL, AK, AZ +43 more• Siemens Medical Solutions USA, Inc

Siemens Medical Solutions USA, Inc: MEVATRON KDS-2,Medical charge-particle radiation therapy ...

Mistreatment of radiation therapy due to inadvertent parameter changes or miss-calibration in Service Mode. The miss-calibration can affect the beam profile and Virtual Wedge angle. This leads to patient mistreatment and alteration of future treatment plans. A second reason is an unplanned Dosimetry calibration data set can be erroneously copied during "Service Mode."

FDAMar 22, 2007AL, AK, AZ +43 more• Siemens Medical Solutions USA, Inc

Unknown Manufacturer: Reverse Shoulder Prosthesis (RSP) custom device component...

Marketed with approval: Investigational devices were implanted during an IDE study prior to receiving approval for the devices in the study; patients were implanted with investigational devices outside of the IDE study; and devices implanted as "custom devices" by the manufacturer did not meet the definition of "custom devices" and were, therefore, unapproved devices.

FDAMar 22, 2007Nationwide

Siemens Medical Solutions USA, Inc: ONCOR Avant Garde,Medical charge-particle radiation thera...

Mistreatment of radiation therapy due to inadvertent parameter changes or miss-calibration in Service Mode. The miss-calibration can affect the beam profile and Virtual Wedge angle. This leads to patient mistreatment and alteration of future treatment plans. A second reason is an unplanned Dosimetry calibration data set can be erroneously copied during "Service Mode."

FDAMar 22, 2007AL, AK, AZ +43 more• Siemens Medical Solutions USA, Inc

Siemens Medical Solutions USA, Inc: MEVATRON M2/PRIMUS Mid,Medical charge-particle radiation ...

Mistreatment of radiation therapy due to inadvertent parameter changes or miss-calibration in Service Mode. The miss-calibration can affect the beam profile and Virtual Wedge angle. This leads to patient mistreatment and alteration of future treatment plans. A second reason is an unplanned Dosimetry calibration data set can be erroneously copied during "Service Mode."

FDAMar 22, 2007AL, AK, AZ +43 more• Siemens Medical Solutions USA, Inc

Siemens Medical Solutions USA, Inc: MEVATRON M-2 6740,Medical charge-particle radiation thera...

Mistreatment of radiation therapy due to inadvertent parameter changes or miss-calibration in Service Mode. The miss-calibration can affect the beam profile and Virtual Wedge angle. This leads to patient mistreatment and alteration of future treatment plans. A second reason is an unplanned Dosimetry calibration data set can be erroneously copied during "Service Mode."

FDAMar 22, 2007AL, AK, AZ +43 more• Siemens Medical Solutions USA, Inc

Electric Mobility Corp: Electric Mobility Corporation (EMC)- Scooters and Turnabo...

Seat and/or lift actuator problems: 1) Models equipped with a Seat Lift, the mast screw and washer holding the Seat Lift Actuator in place will loosen break off or fall out; 2) Models assembled with Seat Lift Actuator or Seat Post Mounting Bolts, the seat may wobble or the seat will break off from the vehicle; 3) Models using Seat-On Lifting brackets with a hoist to raise an EMC vehicle equipped

FDAMar 22, 2007Nationwide• Electric Mobility Corp

Siemens Medical Solutions USA, Inc: MEVATRON M-2 6700,Medical charge-particle radiation thera...

Mistreatment of radiation therapy due to inadvertent parameter changes or miss-calibration in Service Mode. The miss-calibration can affect the beam profile and Virtual Wedge angle. This leads to patient mistreatment and alteration of future treatment plans. A second reason is an unplanned Dosimetry calibration data set can be erroneously copied during "Service Mode."

FDAMar 22, 2007AL, AK, AZ +43 more• Siemens Medical Solutions USA, Inc

Siemens Medical Solutions USA, Inc: ONCOR IMPRESSION,Medical charge-particle radiation therap...

Mistreatment of radiation therapy due to inadvertent parameter changes or miss-calibration in Service Mode. The miss-calibration can affect the beam profile and Virtual Wedge angle. This leads to patient mistreatment and alteration of future treatment plans. A second reason is an unplanned Dosimetry calibration data set can be erroneously copied during "Service Mode."

FDAMar 22, 2007AL, AK, AZ +43 more• Siemens Medical Solutions USA, Inc

Siemens Medical Solutions USA, Inc: ONCOR IMPRESSION Plus,Medical charge-particle radiation t...

Mistreatment of radiation therapy due to inadvertent parameter changes or miss-calibration in Service Mode. The miss-calibration can affect the beam profile and Virtual Wedge angle. This leads to patient mistreatment and alteration of future treatment plans. A second reason is an unplanned Dosimetry calibration data set can be erroneously copied during "Service Mode."

FDAMar 22, 2007AL, AK, AZ +43 more• Siemens Medical Solutions USA, Inc

Siemens Medical Solutions USA, Inc: MEVATRON MD-2,Medical charge-particle radiation therapy s...

Mistreatment of radiation therapy due to inadvertent parameter changes or miss-calibration in Service Mode. The miss-calibration can affect the beam profile and Virtual Wedge angle. This leads to patient mistreatment and alteration of future treatment plans. A second reason is an unplanned Dosimetry calibration data set can be erroneously copied during "Service Mode."

FDAMar 22, 2007AL, AK, AZ +43 more• Siemens Medical Solutions USA, Inc

Siemens Medical Solutions USA, Inc: ONCOR Expression,Medical charge-particle radiation therap...

Mistreatment of radiation therapy due to inadvertent parameter changes or miss-calibration in Service Mode. The miss-calibration can affect the beam profile and Virtual Wedge angle. This leads to patient mistreatment and alteration of future treatment plans. A second reason is an unplanned Dosimetry calibration data set can be erroneously copied during "Service Mode."

FDAMar 22, 2007AL, AK, AZ +43 more• Siemens Medical Solutions USA, Inc

Siemens Medical Solutions USA, Inc: MEVATRON KDS,Medical charge-particle radiation therapy sy...

Mistreatment of radiation therapy due to inadvertent parameter changes or miss-calibration in Service Mode. The miss-calibration can affect the beam profile and Virtual Wedge angle. This leads to patient mistreatment and alteration of future treatment plans. A second reason is an unplanned Dosimetry calibration data set can be erroneously copied during "Service Mode."

FDAMar 22, 2007AL, AK, AZ +43 more• Siemens Medical Solutions USA, Inc

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