Reported Jul 31, 2013 · Terminated
Brivo NM615, is an all-purpose, single detector integrated nuclear imaging system. Product Usage: The Brivo NM 615 is…
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?
- Brivo NM615, is an all-purpose, single detector integrated nuclear imaging system
- Product UsageThe Brivo NM 615 is an emission computed tomography system intended to detect the location and distribution of gamma ray photon emitting radionuclides in the body and to produce cross-sectional images through computer reconstruction of the data. The Brivo NM 615 system is intended for General Nuclear Medicine imaging procedures using variety of scanning modes supported by various acquisition types. This generic type of device may include signal analysis and display equipment, patient and equipment supports, and accessories
- Lot codes and dates
- System ID
030151NU17387171NU01405456NM615406222LN615478272NM702304NM615A5635609HC0541NU03HC3366NU02NM24011NM24015ZA1819NM04ZA2446NM01
- System ID
- Amount recalled
- 13
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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