OEC 3D Imaging — Class II medical device recall Z-2160-2021
Terminated recall by GE OEC Medical Systems, Inc, reported 2021-08-04, distributed nationwide. There is a potential that the coin cell battery used to monitor X-Ray tube temperature may deplete early causi
| Recall number | Z-2160-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | GE OEC Medical Systems, Inc, Salt Lake City, UT, United States |
| Recall initiated | 2021-06-10 |
| Classified | 2021-07-29 |
| Reported by FDA | 2021-08-04 |
| Terminated | 2024-05-09 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AU, BE, BR, BS, CA, CH, CL, CN, CO, CR, CZ, DE, DK, DO, EC, EG, ES, FI, FR, GB, GR, HK, HN, HR, HU, ID, IL, IN, IT, JM, JP, KR, KW, LT, MX, MY, NG, NO, NZ, PA, PE, PH, PK, PL, RO, RU, SA, SE, SG, SK, TH, TR, TT, TW, UY, VN, ZA |
| Quantity | 3 units |
Product
OEC 3D Imaging, Image-Intensified Fluoroscopic X-Ray System, Mobile - Product Usage: designed to provide fluoroscopic and digital spot images of adult and pediatric populations during diagnostic, interventional, and surgical procedures
Reason for recall
There is a potential that the coin cell battery used to monitor X-Ray tube temperature may deplete early causing the system to become inoperable.
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-2160-2021. 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.