Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1960-2012 — 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 fun

U.S. FDA — Device Enforcement · United States · 2012-05-24 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1960-2012
Date of alert
2012-05-24
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
GE Healthcare, LLC
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
0847490042
Reported risk: 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
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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