GE Nuclear Medicine 600/800 series systems — Class I medical device recall Z-1056-2023
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-1056-2023 |
|---|---|
| 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 | 34 units |
| Serial numbers | 0000064GY51011, 26043, 64GX51001, 64GY51002, 64GY51003, 64GY51004, 64GY51005, 64GY51006, 64GY51007, 64GY51008, 64GY51009, 64GY51010, 64GY51011, 64GY51012, 64GY51013, 64GY51014, 64GY51015, 64GY51016, 64GY51017, 64GY51018, 64GY51019, 64GY51020, 64GY51021, 64GY51022, 64GY51023 and 9 more |
| Model numbers | 5376204-41, H3100JZ, H3101RL |
Product
GE Nuclear Medicine 600/800 series systems, specifically: a) OPTIMA O640 X 3/8 inch NR, b) DISCOVERY O640 X 3/8 inch, c) NM OPTIMA O640 X 3/8 inch, d) O640 NM Gantry 3/8 inch, e) O640 NM GANTRY FINAL ASSY, f) OPTIMA O640 X 3/8 inch; 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-1056-2023. 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.