Reported Jul 31, 2013 · Terminated
Discovery NM 630, dual detector free-geometry integrated nuclear imaging system. Product Usage: The GE Discovery NM 630…
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 630, dual detector free-geometry integrated nuclear imaging system
- Product UsageThe GE Discovery NM 630 system is a medical tool intended for use by appropriately trained healthcare professionals to aid in detecting, localizing, diagnosing of diseases and in assessment of 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. The GE Discovery NM 630 system is a Nuclear Medicine (NM) system, which is intended to yield 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 imaging features designed to enhance image quality. The scanning modes include planar mode (Static, Multi-gated, Dynamic and Whole body scanning) and tomographic mode (SPECT, Gated SPECT, Whole body SPECT). The acquisition types include single and multi-isotope/ multi peak frame/list mode single-photon imaging. The imaging-enhancement features include assortment of collimators, gating by physiological signals, and real-time automatic body contouring. The GE Discovery NM 630 system may include signal analysis and display equipment, patient and equipment supports, components and accessories. The system may be used for patients of all ages
- Lot codes and dates
- System ID
108 of 108 codes
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
- System ID
- Amount recalled
- 108
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.
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.
Free recall alerts
Get alerted about new GE Healthcare, LLC recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.