GE Healthcare Infinia I — Class II medical device recall Z-0888-2025
Ongoing recall by GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING, reported 2025-01-22. GE HealthCare has become aware that certain Infinia, VariCam/VG/VH, Brivo NM 615, Discovery NM 630, Discovery
| Recall number | Z-0888-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING, Tirat Carmel, Israel |
| Recall initiated | 2024-12-18 |
| Classified | 2025-01-10 |
| Reported by FDA | 2025-01-22 |
| Quantity | 36 units |
| UPC / GTIN / UDI-DI | 00082426050012, 00082426070041, 00082426100069, 00082426150040 |
| Serial numbers | 16143, 16179, 16315, 16335, 16353, 16364, 17219, 17339, 17566, 17799, 18442, 18604, 18605, 18611, 18624, 18627, 18628, 18629, 18637, 18639, 18641, 18644, 18645, 18646, 18647 and 10 more |
Product
GE Healthcare Infinia I, Model/Catalog Numbers: 1) 5178728, 2) H3000WE, 3) H3000WM, 4) H3000YG; System, Tomography, Computed, Emission
Reason for recall
GE HealthCare has become aware that certain Infinia, VariCam/VG/VH, Brivo NM 615, Discovery NM 630, Discovery NM/CT 670, and Optima NM/CT 640 Nuclear Medicine systems (see Affected Products Details and Appendices) could have been transported or relocated without proper detector support, which can result in excessive load being applied to the detector mounting mechanisms. If this occurs, it can potentially result in a detector fall and lead to life-threatening bodily injury.
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-0888-2025. 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.