Brivo NM615 — Class II medical device recall Z-0189-2015
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-0189-2015 |
|---|---|
| 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 | 22 |
| Model numbers | H2401MN, H2401MP, H2401MR, H2401MT, H2401MW, H2401NJ, H3100TN, H3100TP, H3100TR, H3100TT, H3100TW, H3100WZ |
Product
Brivo NM615, is an all-purpose, single detector integrated nuclear imaging system. Models H3100TP, H3100TN, H3100TT, H3100TR, H3100TW, H3100WZ, H2401MP, H2401MN, H2401MT, H2401MR, H2401MW, H2401NJ. Product Usage: The Brivo NM 615 is an emission computed tomography system intended to detect the location and distribution of gamma ray photon emitting radionuclides in the body and to produce cross-sectional images through computer reconstruction of the data. The Brivo NM 615 system is intended for General Nuclear Medicine imaging procedures using variety of scanning modes supported by various acquisition types. This generic type of device may include signal analysis and display equipment, patient and equipment supports, and accessories
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-0189-2015. 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.