GE Healthcare Omni Legend — Class II medical device recall Z-1112-2026
Completed recall by GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING, reported 2026-01-28, distributed nationwide. There is a potential intermittent issue on certain Omni Legend systems that can result in a streaking artifact
| Recall number | Z-1112-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Completed |
| Voluntary or mandated | Voluntary |
| Recalling firm | GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING, Haifa, Israel |
| Recall initiated | 2025-12-24 |
| Classified | 2026-01-16 |
| Reported by FDA | 2026-01-28 |
| Distributed | Nationwide (US) |
| Countries outside the US | AR, AU, BE, BR, CA, CH, CL, CO, DE, EE, ES, FR, GB, GR, HK, HU, ID, IL, IN, IT, JP, KR, LT, LU, MX, NL, NZ, PL, RO, RU, SA, SE, SV, TH, TW, ZA |
| Quantity | 364 units |
| UPC / GTIN / UDI-DI | 00195278454218, 00195278592309, 00195278792822, 00195278901439 |
| Serial numbers | C1PMT2300279HM, C1PMT2400123HM, C1PMT2400126HM, C1PMT2400172HM, C1PMT2400185HM, C1PMT2400197HM, C1PMT2400226, C1PMT2400245HM, C1PMT2400271HM, C1PMT2400277HM, C1PMT2400296HM, C1PMT2400305HM, C1PMT2400328HM, C1PMT2400342HM, C1PMT2500012HM, C1PMT2500018HM, C1PMT2500053HM, C1PMT2500071HM, C1PMT2500074HM, C1PMT2500083HM, C1PMT2500086HM, C1PMT2500089HM, C1PMT2500093HM, C1PMT2500111HM, C1PMT2500115HM and 393 more |
Product
GE Healthcare Omni Legend, sold under the following names: OMNI Legend 16, Omni Legend 21, OMNI Legend 32, Omni Legend PET Gantry 16cm - MEA, Omni Legend PET Gantry 16cm Haifa LM, Omni Legend PET Gantry 16cm Mobile, Omni Legend PET Gantry 21cm - BJ for Global, Omni Legend PET Gantry 21cm - Global Haifa LM, Omni Legend PET Gantry 21cm - Mobile, Omni Legend PET Gantry 21cm WSO LM, Omni Legend PET Gantry 32cm - MEA, Omni Legend PET Gantry 32cm Haifa LM, Omni Legend PET Gantry 32cm Mobile, OMNI PET Gantry 15cm, Omni PET Gantry 15cm - WSO, OMNI PET Gantry 15cm Cardiac- WSO, OMNI PET Gantry 15cm ES - WSO, Omni PET Gantry 15cm Mobile WSO, Omni PET Gantry 21cm - WSO, Omni PET Gantry 21cm Mobile - WSO, OMNI PET Gantry 30cm, Omni PET Gantry 30cm - WSO; System, Tomography, Computed, Emission
Reason for recall
There is a potential intermittent issue on certain Omni Legend systems that can result in a streaking artifact in the PET clinical scan images. This streaking artifact is most easily identified in transaxial slices on the acquisition console (both corrected and non-corrected for attenuation).
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-1112-2026. 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.