Reported Jul 31, 2013 · Terminated
Discovery NM/CT 670 dual detector free-geometry integrated nuclear imaging system. Product Usage: The GE Discovery…
GE Healthcare, LLC
High riskUsing this product could cause serious injury, illness or death — stop using it now.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?
- Discovery NM/CT 670 dual detector free-geometry integrated nuclear imaging system
- Product UsageThe GE Discovery NM/CT 670 system is a medical tool intended for use by appropriately trained healthcare professionals to aid in detecting, localizing, diagnosing of diseases and organ function for the evaluation of diseases, trauma, abnormalities, and disorders such as, but not limited to, cardiovascular disease, neurological disorders and cancer. The system output can also be used by the physician for staging and restaging of tumors, planning, guiding, and monitoring therapy
- Lot codes and dates
- System ID
213 of 213 codes
082826002108282600220850260118085026012208502601280850260131085026013208532600940853260099085626003308562600340856260035091026229709102623040910262310091026231909102623220910262325091026234409102632230910263228091026323109102632350910263239091026324109102632430910263250091026413509102641410910264147091026507409102650750910265076092026909708242604004308242604004408242606000508242607002808242607003008242608002008242609002908242609003008242613002908242613003008242615002608242616004208242621002008242623002008302600940841008302602368371108302620100681000001NUC1200028NUC0100042NUC0200046NUC0600065NUC0800123NUC0100149NUC0100149NUC0300197NUC14
- System ID
- Amount recalled
- 213
This recall covers 7 products
The agency filed one notice per product. You are reading one of them; the other 6 are below.
Where it was sold
Why it was recalled
Stop using this product now
GE became aware of an incident at a VA Medical Center facility in the US in which a patient died due to injuries sustained while being scanned on an Infinia Hawkeye 4 Nuclear Medicine System. UPDATE: On July 03, 2013 GE notified hospitals that they are recalling several Nuclear Medicine Imaging Systems because serious injuries or deaths could occur due to the failure mode associated with this re
Using this product could cause serious injury, illness or death — stop using it now.
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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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