Reported Mar 20, 2013 · Terminated
Optima MR450w, Discovery MR450, Discovery MR750, Signa HDx, Signa HDxt, Signa HDi, Signa Vibrant, and GE 1.5T Signa HDe…
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?
- Optima MR450w, Discovery MR450, Discovery MR750, Signa HDx, Signa HDxt, Signa HDi, Signa Vibrant, and GE 1.5T Signa HDe MR System. The GE Signa HDx MR system is a whole body magnetic resonance scanner.
- Lot codes and dates
- Serial Number
2,041 of 2,041 codes
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
- Serial Number
- Amount recalled
- 4026 (1672 US; 2354 OUS)
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
Why it was recalled
An error on the SR Viewer Reporting Tool in which edits can be made on a report and can be saved into incorrect reports.
This product could cause temporary or reversible health problems — stop using it.
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