Reported Sep 25, 2013 · Terminated
GE Healthcare, Advantage Workstation, READY View Application. Image analysis 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 Healthcare, Advantage Workstation, READY View Application. Image analysis software.
- Lot codes and dates
- Mfg Lot or Serial #
318 of 318 codes
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
- Mfg Lot or Serial #
- Amount recalled
- 318 (28 USm 290 OUS)
This recall covers 5 products
The agency filed one notice per product. You are reading one of them; the other 4 are below.
Where it was sold
Why it was recalled
GE Healthcare has become aware that when analyzing fMRI images using the READY View application software, incorrect fMRI activation maps may be computed and displayed.
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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