OEC 9800 REF Image-Intensified Fluoroscopic X-Ray System — Class II medical device recall Z-0706-2025
Ongoing recall by GE OEC Medical Systems, Inc, reported 2024-12-25, distributed in AK, AZ, CA, CO, CT, DC, FL, GA…. Due to manufacturing issue of insufficient sealing of X-ray tubes and can result in a potential oil leak and l
| Recall number | Z-0706-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | GE OEC Medical Systems, Inc, Salt Lake City, UT, United States |
| Recall initiated | 2024-11-21 |
| Classified | 2024-12-18 |
| Reported by FDA | 2024-12-25 |
| Distributed | AK, AZ, CA, CO, CT, DC, FL, GA, GU, HI, IA, ID, IL, IN, KS, KY, LA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NJ, NM, NV, NY, OH, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY |
| Countries outside the US | AU, BR, CA, CH, CL, CR, GB, IN, IT, PH, PL, PT, SE |
| Quantity | 25 systems |
| Reason classes | packaging |
| UPC / GTIN / UDI-DI | 00840682114349 |
Product
OEC 9800 REF Image-Intensified Fluoroscopic X-Ray System, Mobile. The Series OEC 9800 is designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical and interventional procedures. Clinical application may include cholangiography, endoscopy, urologic, orthopedic, neurologic, vascular, cardiac, critical care and emergency room procedures.
Reason for recall
Due to manufacturing issue of insufficient sealing of X-ray tubes and can result in a potential oil leak and loss of fluoroscopic imaging capability.
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-0706-2025. 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.