Company: GE Healthcare LLC
Date of Enforcement Report:3/12/2014
Class lI:
PRODUCT
GE Healthcare, Model Number/ Description: 5342114 GSI Viewer 1.10 on AW VolumeShare 4 (AW 4.5); 5342114-2 GSI Viewer 1.10 on AW VolumeShare 4 (AW 4.5); 5342114-3 GSI Viewer 1.10 on AW VolumeShare 4 (AW 4.5); 5342114-4 GSI Viewer 1.11 on AW VolumeShare 4 (AW 4.5); 5401757 GSI Viewer 1.20 on AW VolumeShare 3 (AW4.4). Computed Tomography X-Ray system
Recall Number Z-1148-2014
REASON
When performing a secondary capture generated from GSI Viewer, the header information is correct on the images. However, when changing the ROI (region of interest) and zooming in, the DICOM header does not change to reflect the new image, thus the line measurements may be inaccurate.
RECALLING FIRM/MANUFACTURER
GE Healthcare LLC, Waukesha , WI on 3/25/2011. Voluntary: Firm Initiated recall is complete.
VOLUME OF PRODUCT IN COMMERCE
283
DISTRIBUTION
Nationwide and Internationally
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