Reported Jan 20, 2021 · Ongoing
GE NM/CT 850 system Model Number H3907AD - Product Usage: intended for general Nuclear Medicine imaging procedures for…
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 NM/CT 850 system
- Model Number H3907AD - Product Usageintended for general Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body
- Lot codes and dates
- Serial numbers
85EY67048850Y6101885EY6704585EY6704685EY67047850Z6103885EY67043850Z6104285EZ67056850Z61043850Z61044850Z61045850Z61041850Z61039850Z6104085EZ6705585EZ6705385EZ67054850Y6101985EY6704485EY6704985EZ6705285EY6705085EZ67051
- Serial numbers
- Amount recalled
- 24 units
This recall covers 6 products
The agency filed one notice per product. You are reading one of them; the other 5 are below.
Why it was recalled
GE Healthcare has become aware that rotor bearing screws were found loose on one detector in the field, leading to the release of one of the four rotor bearings in the detector.
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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