Reported Jul 31, 2013 · Terminated
GE Healthcare Infinia Hawkeye 4 Option For Dual-Head Variable Angle Gamma Camera, Hawkeye Option for Dual-Head Variable…
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?
- GE Healthcare Infinia Hawkeye 4 Option For Dual-Head Variable Angle Gamma Camera, Hawkeye Option for Dual-Head Variable Angle Gamma Camera (this includes GE Quasar Nuclear Medicine Systems). Nuclear Medicine
- Systems Infinia devices Product UsageThe intended use of the Quasar system is to perform general Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body, using a variety of scanning modes supported by various acquisition types and optional imaging features designed to enhance image quality in Oncology, Cardiology, Neurology and other clinical diagnostic imaging applications
- Lot codes and dates
- System ID
2,474 of 2,474 codes
11533891299296255500726218012638808269459327607232768147276920027759452812777282708728830510828260003082826000508282600060828260007082826000908282600110828260013082826001508282600170828260018082826001908282600200834260003083426000808342600128352600070835260010083526001308432600290843260032084326003408432600370843260044084326004708432600480847260025085026006008502600610850260063085026006408502600650850260066085026006708502600680850260069085026007008502600730850260074085026007508502600760850260077085026007908502600800850260081085026008208502600830850260084
- System ID
- Amount recalled
- 2474
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.
Using this product could cause serious injury, illness or death — stop using it now.
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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