Reported Jul 18, 2012 · Terminated
GE Advantage CT/PET Fusion for Advantage Windows Workstation with Volume View CT Colonography/Navigator 2 software.…
GE Healthcare, LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: GE Healthcare, LLC · 3000 N Grandview Blvd · Waukesha, WI · 53188-1615
Is this the product you have?
- 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).
- Lot codes and dates
70 of 70 codes
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
- Amount recalled
- 70
Where it was sold
Why it was recalled
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 Fusion application. Volume Viewer allows two studies (one PET and one CT) that are registered in the same spatial domain to be viewed simultaneously in fused mode. The two images should be aligned to th
This product could cause temporary or reversible health problems — stop using it.
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