Discovery NM/CT 670 dual detector free-geometry integrated nuclear… — Class II medical device recall Z-0186-2015
Terminated recall by GE Healthcare, LLC, reported 2014-11-19, distributed nationwide. GE is issuing this recall due to a potential safety issue related to a portion of the system falling onto the
| Recall number | Z-0186-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | GE Healthcare, LLC, Waukesha, WI, United States |
| Recall initiated | 2014-10-14 |
| Classified | 2014-11-07 |
| Reported by FDA | 2014-11-19 |
| Terminated | 2015-02-27 |
| Distributed | Nationwide (US) |
| Countries outside the US | AR, AT, AU, BE, BG, BR, CA, CH, CL, CN, CO, CY, CZ, DE, DK, DO, DZ, EC, EE, EG, ES, FI, FR, GB, GR, HK, HR, HU, ID, IE, IL, IN, IR, IT, JP, KR, KW, LB, LT, LV, MA, MT, MX, MY, NL, NO, NZ, PA, PE, PH, PK, PL, PT, QA, RO, RU, SA, SE, SG, SK, TH, TN, TR, TW, UA, UY, VE, ZA |
| Quantity | 255 |
| UPC / GTIN / UDI-DI | 00082426040044, 00082426040051, 00082426070034, 00082426100052, 00082426150026 |
| Model numbers | H2401LS, H2401LZ, H2402LS, H3100NA, H3100PP, H3100RA |
Product
Discovery NM/CT 670 dual detector free-geometry integrated nuclear imaging system. Models H3100NA, H3100PP, H3100RA, H2401LS, H2401LZ, H2402LS. Product Usage: The GE Discovery NM/CT 670 system is 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.
Reason for recall
GE is issuing this recall due to a potential safety issue related to a portion of the system falling onto the patient during a scan due to fasteners being loose that secured the camera to the gantry. GE is updating the Preventative Maintenance procedure and schedule, and added an additional Preventative Maintenance check for loose fasteners on the Nuclear Medicaine systems.
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-0186-2015. 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.