GEHC OEC 8800 Mobile Fluoroscopic X-ray System — Class II medical device recall Z-2221-2012
Terminated recall by GE OEC Medical Systems, Inc, reported 2012-08-29. X-ray units did not meet manufacturer's specification for linearity.
| Recall number | Z-2221-2012 |
|---|---|
| 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 | 2007-10-19 |
| Classified | 2012-08-17 |
| Reported by FDA | 2012-08-29 |
| Terminated | 2012-08-17 |
| Countries outside the US | AE, AU, BR, CA, CN, CO, CY, CZ, DE, ES, FI, FR, GB, GR, IT, JP, KR, MY, NL, NO, NZ, SE, TR, TW |
| Quantity | 175 units |
| Serial numbers | 2791PU2, 2797PU9, 2817PU5, 2824PU1, 2827PU4, 2899PU3, 2900PU9, 2901PU7, 2918PU1, 2919PU9, 2922PU3, 2939PU7, 3095PU7, 3103PU9, 3107PU0, 3219PU3, 3223PU5, 3224PU3, 3230PU0, 3233PU4, 3236PU7, 3358PU9, 3368PU8, 3500PU6, 3513PU9 and 150 more |
Product
GEHC OEC 8800 Mobile Fluoroscopic X-ray System, GE Healthcare, Surgery, Salt Lake City, UT. Mobile fluoroscopic examination of human anatomy.
Reason for recall
X-ray units did not meet manufacturer's specification for linearity.
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-2221-2012. 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.