Reported May 7, 2014 · Terminated
GE Healthcare, CardiacVX [CardiacVX (1.1.0 Ext. d) and CardiacVX Flow (1.1.0 Ext. d) analysis software running on…
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, CardiacVX [CardiacVX (1.1.0 Ext. d) and CardiacVX Flow (1.1.0 Ext. d) analysis software running on Advantage Workstation]. Model #'s 5434389-2 and 5434384-2. The GE Cardiac VX for MRI is an analytical software tool, which provides reproducible tools for the review and reporting of medical images.
- Lot codes and dates
- FMI# 60857 &
- DescrCARDIAC VX Mfg Lot or Serial # System ID
183 of 183 codes
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
- Amount recalled
- 101 (1 US , 100 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
GE Healthcare has recently become aware of a potential safety issue due to higher than actual flow values reported on CardiacVX and CardiacVX Flow running on Advantage Workstation.
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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