Reported Oct 27, 2021 · Terminated
Optima MR450w 1.5T nuclear magnetic resonance imaging system
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 1.5T nuclear magnetic resonance imaging system
- Lot codes and dates
- Software version DV29.1
- Amount recalled
- 13 devices
This recall covers 10 products
The agency filed one notice per product. You are reading one of them; the other 9 are below.
Where it was sold
Why it was recalled
Under certain conditions, some slices may be missing which can lead to a gap of anatomy in the 3D Volume images.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
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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