Discovery NM 630 — Class I medical device recall Z-1791-2013
Terminated recall by GE Healthcare, LLC, reported 2013-07-31, distributed nationwide. GE became aware of an incident at a VA Medical Center facility in the US in which a patient died due to injuri
| Recall number | Z-1791-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | GE Healthcare, LLC, Waukesha, WI, United States |
| Recall initiated | 2013-06-13 |
| Classified | 2013-07-23 |
| Reported by FDA | 2013-07-31 |
| Terminated | 2014-06-19 |
| Distributed | Nationwide (US) |
| Countries outside the US | AF, AR, AT, AU, BE, BR, CA, CH, CL, CN, CO, CR, CY, CZ, DE, DK, DO, DZ, EC, EG, ES, FI, FR, GB, GR, HK, HR, HU, ID, IE, IL, IN, IR, IT, JO, JP, KR, KW, LB, LT, LV, MA, MT, MX, MY, NL, NO, NZ, PA, PE, PH, PK, PL, PT, RO, RU, SA, SE, SG, SK, TH, TN, TR, TW, UA, UY, VE, VN, ZA |
| Quantity | 108 |
Product
Discovery NM 630, dual detector free-geometry integrated nuclear imaging system. Product Usage: The 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.
Reason for recall
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
Machine access
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Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.