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[Enforcement] GE Healthcare, LLC — GE Advantage CT/PET Fusion for Advantage Windows Wor...

Jul 18, 2012
Published: 2012-07-18Captured: 2026-02-09GE Healthcare, LLCProduct: GE Advantage CT/PET Fusion for Advantage Windows Workstation with Volume View CT Colonography/Navigator 2 software. (Version 4.0, 4.1,or 4.2) The Advantage CT/PET Fusion clinical application provid...

FDA issued a Class II enforcement action. Affects GE Healthcare, LLC. Reason: GE Healthcare has become aware of a potential safety issue due to incorrect alignment of fused CT and PET images associa.

  • •Classification: Class II
  • •Firm: GE Healthcare, LLC
  • •Status: Terminated
  • •Distribution: Worldwide Distribution-USA (nationwide) including the states of CA, FL, IL, MA, NJ, NY, SC, and TX and ...
Reason

GE Healthcare has become aware of a potential safety issue due to incorrect alignment of fused CT and PET images associated with the CT/PET fusion capabilities of your Volume Viewer and CT/PET Fusi...

Status:Terminated
Distribution

Worldwide Distribution-USA (nationwide) including the states of CA, FL, IL, MA, NJ, NY, SC, and TX and the countries of TURKEY, TUNISIA, TAIWAN, SPAIN, SINGAPORE, SAUDI ARABIA, RUSSIAN FEDERATION, ...

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GE Advantage CT/PET Fusion for Advantage Windows Workstation with Volume View CT Colonography/Navigator 2 software. (Version 4.0, 4.1,or 4.2) The Advantage CT/PET Fusion clinical application provides easy comparison of three dimensional (3D) anatomical images from Computed Tomography (CT) and functional images from Positron Emission Tomography (PET). | TrueMedDevice