FDA Device recall Z-0704-2025
OEC Elite REF Image-Intensified Fluoroscopic X-Ray System, Mobile
- FDA Device
- Class II
- ongoing
- Published 2024-12-25
On 2024-12-25 the FDA classified a Class II recall of OEC Elite REF Image-Intensified Fluoroscopic X-Ray System, Mobile by Ge Oec Medical Systems, citing 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0704-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-11-21 |
| Published | 2024-12-25 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Ge Oec Medical Systems |
| Distribution | AK, AZ, CA, CO, CT, DC, FL, GA, 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 |
Product
OEC Elite REF Image-Intensified Fluoroscopic X-Ray System, Mobile. The OEC Elite mobile C-arm is intended to provide fluoroscopic and digital spot images of the patient anatomy, interventional tools/devices, and contrast agents during diagnostic, interventional, and surgical procedures.
Reason
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.
Identifiers
| code_info | Product Name: OEC Elite GTIN code: 00001234567895 Lot/Serial Numbers / UDI codes: FAXXXE00254 (01)00840682121729(11)190…Product Name: OEC Elite GTIN code: 00001234567895 Lot/Serial Numbers / UDI codes: FAXXXE00254 (01)00840682121729(11)190400(21)FAXXXE00254 FBHXTX00837 (01)00840682121729(11)230300(21)FBHXTX00837 FBHXTX00912 (01)00840682121729(11)230500(21)FBHXTX00912 FBHXTX01278 (01)00840682121729(11)240800(21)FBHXTX01278 FBXXXE00731 (01)00840682121729(11)190500(21)FBXXXE00731 FBMHTX00470 (01)00840682121729(11)240900(21)FBMHTX00470 F2XXTX00801 (01)00840682121729(11)240800(21)F2XXTX00801 FBHXXX00171 (01)00840682121729(11)180600(21)FBHXXX00171 FBXXXE00715 (01)00840682121729(11)190500(21)FBXXXE00715 FBMHTX00444 (01)00840682121729(11)240600(21)FBMHTX00444 FBXXTE02974 (01)00840682121729(11)240800(21)FBXXTE02974 FBMHTX00466 (01)00840682121729(11)240900(21)FBMHTX00466 FAXXTE00672 (01)00840682121729(11)221200(21)FAXXTE00672 F9XXTX00276 (01)00840682121729(11)230900(21)F9XXTX00276 FAXXTE01160 (01)00840682121729(11)240800(21)FAXXTE01160 FBMHTX00454 (01)00840682121729(11)240800(21)FBMHTX00454 FBMHTX00455 (01)008406 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0704-2025%22
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