Reported Feb 16, 2022 · Ongoing
GE Healthcare MR superconducting magnets, a component of GE 1.5T SIGNA HDx MR System, GE 3.0T SIGNA HDx MR System, GE…
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 MR superconducting magnetsa component of GE 1.5T SIGNA HDx MR SystemGE 3.0T SIGNA HDx MR SystemGE 1.5T SIGNA HDxt MR SystemGE 3.0T SIGNA HDxt MR System1.5T SIGNA HDxt3.0T SIGNA HDxt1.5T SIGNA HDxt Mobile3.0T SIGNA HDxt MobileSIGNA HDiSIGNA Vibrant systemsnuclear magnetic resonance imaging systems
- Lot codes and dates
- All systems.
- Amount recalled
- 17,228 devices total in this field correction
This recall covers 32 products
The agency filed one notice per product. You are reading one of them; the other 31 are below.
19 more are in the archive.
Where it was sold
Why it was recalled
The magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the venting requirements.
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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