Reported Sep 30, 2020 · Terminated
NM/CT 860, SPECT/CT
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?
- NM/CT 860, SPECT/CT
- Lot codes and dates
4 of 4 products
Products covered by this recall Model / number Product as published H3908ADSerial # 860X62001 , System ID:E6843969 H3908AESerial # 870X64005 , System ID:HC4387NU05 H3100ASSerial # 860X62002 , System ID:PL0399NM01 H3100AS— - Amount recalled
- 4 units
This recall covers 8 products
The agency filed one notice per product. You are reading one of them; the other 7 are below.
Where it was sold
Why it was recalled
Rotor bearing screws were found loose on detector.
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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