GE Discovery NM/CT670 — Class II medical device recall Z-0121-2013
Terminated recall by GE Healthcare, LLC, reported 2012-10-31, distributed nationwide. GE Healthcare has recently become aware of a potential safety issue associated with the table pallet of your D
| Recall number | Z-0121-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | GE Healthcare, LLC, Waukesha, WI, United States |
| Recall initiated | 2012-10-12 |
| Classified | 2012-10-23 |
| Reported by FDA | 2012-10-31 |
| Terminated | 2013-11-14 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, BE, CA, CH, CN, DE, DK, EE, EG, ES, FI, FR, GB, HK, IE, IL, IN, IT, JP, KR, NL, NO, PL, TH, TR, TW |
| Quantity | 210 |
| Serial numbers | 000, 00ME1, 21000, 21001, 21002, 21003, 21004, 21005, 21006, 21007, 21008, 210088, 21009, 21010, 21011, 21012, 21013, 21014, 21016, 21017, 21018, 21019, 21020, 21021, 21022 and 185 more |
Product
GE Discovery NM/CT670; GE Discovery NM 630 Product Usage: 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. The GE Discovery NM/CT 670 system, combining Nuclear Medicine (NM) and Computed Tomography (CT) systems, is intended to produce: NM System: 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.
Reason for recall
GE Healthcare has recently become aware of a potential safety issue associated with the table pallet of your Discovery NM/CT 670 and/or Discovery NM630 system which may impact operation safety. At scan setup, during gantry rotation towards scanning position, a potential contact between the table-pallet-edge and the detector was identified. Such occurrence may damage the pallet front-edge and
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0121-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
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.