GE Nuclear Medicine 600/800 series systems — Class I medical device recall Z-1054-2023
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-1054-2023 |
|---|---|
| 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 | 748 units |
| UPC / GTIN / UDI-DI | 00840682139274, 00840682140829, 05002711180700, 05005211181000, 05007611190200, 06017011200200, 06017911200300, 06018611200300, 06042711220500, 06043311220600, 08801511210900 |
| Serial numbers | 0000063GX50023, 0000063GX50036, 0000063GX50048, 0000063GZ50139, 22404, 63GA50153, 63GA50154, 63GA50155, 63GA50156, 63GA50157, 63GA50159, 63GA50160, 63GA50161, 63GA50162, 63GA50163, 63GB50164, 63GB50165, 63GB50166, 63GX50001, 63GX50002, 63GX50003, 63GX50004, 63GX50005, 63GX50006, 63GX50007 and 475 more |
| Model numbers | 5376204-31-1, 5376204-32, 5376204-32-1, 5474054, 5791570, H2405AC, H2406AA, H3100JY, H3101RH, H3910AC, H3910AD, H3910AG, S9630NU |
Product
GE Nuclear Medicine 600/800 series systems, specifically: a) 830, b) 830 / Dismount, c) 830 /, d) 830 / 5842894-20, e) 830 / Dismount / 50HZ, f) 830 / Dismount / 60HZ, g) 830 3/8 inch Detector, h) 830 BJ, i) 830 BJ / 5144407, j) 830 BJ / Dismount, k) 830 ES DEM, l) 830 NM Cyber Defense Configuration Gantry 3/8 inch, m) 830 NM Gantry 3/8 inch, n) 830 NM Gantry 5/8 inch, o) 870 DR NM GANTRY FINAL - NEW ROTOR, p) B615 to D630 UPG, q) D630 NM GANTRY, r) D630 NM GANTRY 3/8 inch WITH NEW ROTOR - MEA, s) D630 NM Gantry 3/8 inch, t) D630 NM GANTRY FINAL ASSEMBLY_, u) D630 with new rotor, v) D630 with new rotor/ 5144407 / Dismount, w) D630 with new rotor/ Dismount, x) DISCOVERY D630 X 3/8 inch, y) DISCOVERY D630 X 3/8 inch, z) DISCOVERY D630 X 3/8 inch, aa) DISCOVERY D630 x 3/8 inch BHW, bb) DISCOVERY D630 X 3/8 inch BJG, cc) DISCOVERY D630 X 3/8 inch MEA, dd) DISCOVERY NM 830 3/8 inch, ee) DISCOVERY NM 830 3/8 inch, ff) NM 830 3/8 inch, gg) NM 830 3/8 inch BJ, hh) NM 830 ES, ii) NM DISCOVERY D630 3/8 inch, jj) NUC GOLDSEAL D630 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-1054-2023. 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.