GE Nuclear Medicine 600/800 series systems — Class I medical device recall Z-1057-2023
Ongoing recall by GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING, reported 2023-02-15, distributed nationwide. A mitigation may not be correctly implemented. If this is the case, the detector can fall, leading to life-thr
| Recall number | Z-1057-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING, Tirat Carmel, Israel |
| Recall initiated | 2022-12-19 |
| Classified | 2023-02-08 |
| Reported by FDA | 2023-02-15 |
| Distributed | Nationwide (US) |
| Countries outside the US | AR, AT, AU, BE, BG, BH, BO, BR, CA, CH, CL, CN, CO, CR, CY, CZ, DE, DK, DZ, EG, ES, FI, FR, GB, GH, GR, HK, HR, HU, ID, IE, IL, IN, IQ, IR, IT, JO, JP, KE, KR, KW, LT, MA, MX, MY, NG, NL, NO, NZ, PA, PE, PH, PK, PL, PT, QA, RO, RS, RU, SA, SE, SG, SK, SV, TH, TR, TW, VN, ZA |
| Quantity | 86 units |
| UPC / GTIN / UDI-DI | 06300311180700, 06302011190300 |
| Serial numbers | 87CA63053, 87CA63054, 87CA63055, 87CA63056, 87CA63057, 87CA63058, 87CA63059, 87CA63060, 87CA63061, 87CA63062, 87CA63063, 87CB63064, 87CB63065, 87CB63066, 87CB63067, 87CB63068, 87CB63069, 87CB63070, 87CB63071, 87CB63072, 87CB63073, 87CB63074, 87CB63075, 87CB63076, 87CB63077 and 61 more |
| Model numbers | 5376204-70-20, H3906CV, H3906CW, H3906DD, H3906FK |
Product
GE Nuclear Medicine 600/800 series systems, specifically: a) 870 CZT O540+ Gantry 7.25mm, b) D670 CZT Gantry 7.25mm, c) DISCOV NM/CT 870 CZT, d) Discovery NMCT 670 CZT O540+, e) NM/CT 870 CZT CYBER DEFENCE, f) NM/CT 870 CZT O540, g) NM/CT 870 CZT WSO, h) NM/CT 870 CZT, i) NM/CT 870 CZT O540+ 7.25MM; Emission Computed Tomography System
Reason for recall
A mitigation may not be correctly implemented. If this is the case, the detector can fall, leading 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-1057-2023. 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.