Reported Oct 28, 2020 · Terminated
Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance - Product Usage: The combined…
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?
- Tomographic Imager Combining Emission Computed Tomography With Nuclear
- Magnetic Resonance - Product UsageThe combined system maintains independent functionality of the MR and PET devices, allowing for single modality MR and / or PET imaging
- Lot codes and dates
- Model5726207-8 and 5741000-28
- Amount recalled
- N/A
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
Potential electrical arc flash within the Power Gradient & RF (PGR) Cabinet.
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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