The OEC 9900 Elite mobile fluoroscopy system — Class II medical device recall Z-1462-2014
Terminated recall by GE OEC Medical Systems, Inc, reported 2014-04-23. GE Healthcare has identified a potential safety issue related to the screws that attach the workstation monito
| Recall number | Z-1462-2014 |
|---|---|
| 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 | 2014-03-31 |
| Classified | 2014-04-16 |
| Reported by FDA | 2014-04-23 |
| Terminated | 2015-10-26 |
| Countries outside the US | AR, AU, CA, CN, EC, HK, IL, IN, JP, KR, MX, NG, PE, RU, SA, SG, TH, TW |
| Quantity | 453 units |
| Model numbers | 9900 |
Product
The OEC 9900 Elite mobile fluoroscopy system (image intensified fluoroscopic x-ray) is designed to provide fluoroscopic and spot-film images of the patient during diagnostic surgical and interventional procedure. Examples of clinical application may include cholangiography, endoscopy, urologic, orthopedic, neurologic, vascular, cardiac, critical care and emergency room procedure. The system may be used for other imaging applications at the physician's discretion.
Reason for recall
GE Healthcare has identified a potential safety issue related to the screws that attach the workstation monitor spring arm to the extension arm on certain OEC 9900 systems, causing the spring arm and monitor to fall forward.
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-1462-2014. 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.