Reported Oct 23, 2013 · Terminated
GE, Optima CT660. Intended to produce cross-sectional images of the body by computer reconstruction of x-ray…
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, Optima CT660. Intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data.
- Lot codes and dates
- Mfg Lot or Serial #
379 of 379 codes
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
- Mfg Lot or Serial #
- Amount recalled
- 380 (52 US & 328 OUS)
This recall covers 6 products
The agency filed one notice per product. You are reading one of them; the other 5 are below.
Where it was sold
Why it was recalled
GE Healthcare has recently become aware of a potential safety issue related with the DMPR function and Screen Saved Images on your scanner which involves Optima CT660, Brivo CT385, Discovery PET/CT 610, Discovery PET/CT 710. The DMPR and Screen Save functionality may possibly generate the same Series UID. It has been seen that some PACS may combine series under a patient using only the Series UID
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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