Company:GE Healthcare, LLC
Date of Enforcement Report 7/18/12
Class ll:
PRODUCT
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). Z-1960-2012
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 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 the same precision as the scanner. Assuming the two images are acquired with a calibrated machine and there is no patient movement between the CT and PET acquisitions, the two images should be visually aligned to a precision of less than one half PET voxel. However, the problem associated with this version of software may introduce a shift of up to 1.5 PET voxels, which can be as much as 8mm with certain zoom factors.
RECALLING FIRM/MANUFACTURER
GE Healthcare, LLC, Waukesha, WI on 5/24/2012. Firm initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
70 units
DISTRIBUTION
Nationwide and Internationally
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