MyoSPECT System — Class II medical device recall Z-2040-2024
Ongoing recall by GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING, reported 2024-06-19, distributed nationwide. There is a potential issue regarding the service handles for the internal lead (Pb) covers in that the handles
| Recall number | Z-2040-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING, Tirat Carmel, N/A, Israel |
| Recall initiated | 2024-04-15 |
| Classified | 2024-06-07 |
| Reported by FDA | 2024-06-19 |
| Distributed | Nationwide (US) |
| Countries outside the US | AR, BE, BR, CA, CZ, ES, FI, FR, GB, IL, IN, IT, JP, MT, MY, PL, SG, TR, TW |
| Quantity | 133 devices |
| UPC / GTIN / UDI-DI | 00195278421579, 00195278421586, 00195278488619, 00195278488626 |
| Serial numbers | MYEB94001, MYGA10001, MYOC93001, NGCA80001, NGCA80002, NGCA80003, NGCA80004, NGCA80005, NGCA80006, NGCA80007, NGCA80008, NGCA80009, NGCA80010, NGCA80011, NGCA80012, NGCA80013, NGCA80014, NGCA80015, NGCA80016, NGCA80017, NGCA80019, NGCA80020, NGCA80021, NGCB80022, NGCB80023 and 108 more |
| Model numbers | H3912AA, H3912AB, H3912B, H3912BC, H3912BD |
Product
MyoSPECT System, Model H3912AA and H3912B, and MyoSPECT ES System, Model H3912AB and H3912BD, dedicated cardiac SPECT (single photon emission computerized tomography system).
Reason for recall
There is a potential issue regarding the service handles for the internal lead (Pb) covers in that the handles could loosen or release which could cause a cover to drop potentially resulting in injury to service personnel due to the weight of the cover.
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-2040-2024. 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.