Reported Mar 12, 2014 · Terminated
GE Healthcare, Model Number/ Description: 5342114 GSI Viewer 1.10 on AW VolumeShare 4 (AW 4.5); 5342114-2 GSI Viewer…
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 Healthcare
- Model Number/ Description5342114 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
- Lot codes and dates
- Mfg Lot or Serial #
283 of 283 codes
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
- Mfg Lot or Serial #
- Amount recalled
- 283 (59 US, 224 OUS)
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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