FDA Device recall Z-0703-2025
OEC 3D 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 3D 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-0703-2025 |
| 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 3D REF Image-Intensified Fluoroscopic X-Ray System, Mobile. The OEC 3D is a mobile fluoroscopic C-Arm imaging system used to assist trained surgeons and other qualified physicians. The system is used to provide fluoroscopic Xray images and volumetric reconstructions 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 3D GTIN code: 00195278096944 Lot/Serial Numbers / UDI codes: FBMHDX00436 (01)00195278096944(11)240800…Product Name: OEC 3D GTIN code: 00195278096944 Lot/Serial Numbers / UDI codes: FBMHDX00436 (01)00195278096944(11)240800(21)FBMHDX00436 FBMHDX00352 (01)00195278096944(11)240500(21)FBMHDX00352 FBMHDX00455 (01)00195278096944(11)240900(21)FBMHDX00455 FBMHDX00384 (01)00195278096944(11)240600(21)FBMHDX00384 FBMHDX00434 (01)00195278096944(11)240900(21)FBMHDX00434 FBMHDX00443 (01)00195278096944(11)240900(21)FBMHDX00443 FBMHDX00407 (01)00195278096944(11)240700(21)FBMHDX00407 FBMHDX00363 (01)00195278096944(11)240500(21)FBMHDX00363 FBMHDX00424 (01)00195278096944(11)240800(21)FBMHDX00424 FBMHDX00442 (01)00195278096944(11)240900(21)FBMHDX00442 FBMHDX00321 (01)00195278096944(11)240300(21)FBMHDX00321 FBMHDX00387 (01)00195278096944(11)240600(21)FBMHDX00387 FBMHDX00339 (01)00195278096944(11)240400(21)FBMHDX00339 FBMHDX00448 (01)00195278096944(11)240900(21)FBMHDX00448 FBMHDX00383 (01)00195278096944(11)240600(21)FBMHDX00383 FBMHDX00437 (01)00195278096944(11)240900(21)FBMHDX00437 FBMHDX00362 (01)001952780 |
|---|
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-0703-2025%22
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