OEC Elite REF Image-Intensified Fluoroscopic X-Ray System, Mobile. The OEC Elite mobile C-arm...
FDA Device Recall #Z-0704-2025 — Class II — November 21, 2024
Recall Summary
| Recall Number | Z-0704-2025 |
| Classification | Class II — Moderate risk |
| Date Initiated | November 21, 2024 |
| Status | Ongoing |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | GE OEC Medical Systems, Inc |
| Location | Salt Lake City, UT |
| Product Type | Devices |
| Quantity | 100 systems |
Product Description
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 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.
Distribution Pattern
U.S.: AK, AZ, CA, CO, CT, DC, FL, GA, Guam, 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, and WY. O.U.S.: Australia, Brazil, Canada, Chile, Costa Rica, India, Italy, Philippines, Poland, Portugal, Sweden, Switzerland, and United Kingdom
Lot / Code Information
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)00840682121729(11)240800(21)FBMHTX00455 FBMHTX00465 (01)00840682121729(11)240900(21)FBMHTX00465 FBXXTE02975 (01)00840682121729(11)240800(21)FBXXTE02975 FBXXTE02976 (01)00840682121729(11)240800(21)FBXXTE02976 FBXXXE00312 (01)00840682121729(11)180900(21)FBXXXE00312 FAXXTE00664 (01)00840682121729(11)221100(21)FAXXTE00664 FBMHTX00450 (01)00840682121729(11)240700(21)FBMHTX00450 FAXXTE01154 (01)00840682121729(11)240700(21)FAXXTE01154 FBXXTE02994 (01)00840682121729(11)240800(21)FBXXTE02994 FAXXTE00544 (01)00840682121729(11)220600(21)FAXXTE00544 FBXXTE01055 (01)00840682121729(11)211200(21)FBXXTE01055 FBXXTE02966 (01)00840682121729(11)240800(21)FBXXTE02966 FBMHTX00467 (01)00840682121729(11)240900(21)FBMHTX00467 FAXXTE00339 (01)00840682121729(11)210600(21)FAXXTE00339 FSXXTX00282 (01)00840682121729(11)220500(21)FSXXTX00282 FAXXXE00231 (01)00840682121729(11)190300(21)FAXXXE00231 FBXXXE00653 (01)00840682121729(11)190400(21)FBXXXE00653 F2XXTX00381 (01)00840682121729(11)220100(21)F2XXTX00381 FBXXXE00008 (01)00840682121729(11)171000(21)FBXXXE00008 FBMHTX00468 (01)00840682121729(11)240900(21)FBMHTX00468 FBXXTP00008 (01)00840682121729(11)240700(21)FBXXTP00008 FSXXTX00501 (01)00840682121729(11)240400(21)FSXXTX00501 F2XXTX00802 (01)00840682121729(11)240800(21)F2XXTX00802 FAXXTE01157 (01)00840682121729(11)240700(21)FAXXTE01157 FBMHTX00447 (01)00840682121729(11)240600(21)FBMHTX00447 FBMHDX00049 (01)00195278096944(11)220100(21)FBMHDX00049 FBXXTE02312 (01)00840682121729(11)230900(21)FBXXTE02312 F9XXTX00301 (01)00840682121729(11)240100(21)F9XXTX00301 FBXXTE02965 (01)00840682121729(11)240800(21)FBXXTE02965 FBXXXE00654 (01)00840682121729(11)190400(21)FBXXXE00654 FBMHTX00452 (01)00840682121729(11)240800(21)FBMHTX00452 FBXXTE00561 (01)00840682121729(11)201100(21)FBXXTE00561 FBXXTE02963 (01)00840682121729(11)240800(21)FBXXTE02963 FBXXTE02109 (01)00840682121729(11)230600(21)FBXXTE02109 FBXXTP00006 (01)00840682121729(11)240700(21)FBXXTP00006 FBXXTP00007 (01)00840682121729(11)240700(21)FBXXTP00007 F2XXTX00021 (01)00840682121729(11)191100(21)F2XXTX00021 FBXXTE02991 (01)00840682121729(11)240800(21)FBXXTE02991 FBXXTE02992 (01)00840682121729(11)240800(21)FBXXTE02992 F2XXTX00799 (01)00840682121729(11)240800(21)F2XXTX00799 FSXXTX00514 (01)00840682121729(11)240600(21)FSXXTX00514 FBXXTE01754 (01)00840682121729(11)230100(21)FBXXTE01754 FBXXTE02914 (01)00840682121729(11)240600(21)FBXXTE02914 FBXXTE00515 (01)00840682121729(11)201000(21)FBXXTE00515 FAXXXE00049 (01)00840682121729(11)180200(21)FAXXXE00049 FBXXXE00272 (01)00840682121729(11)180900(21)FBXXXE00272 FSXXXX00004 (01)00840682121729(11)190400(21)FSXXXX00004 FBMHTX00433 (01)00840682121729(11)240400(21)FBMHTX00433 FBMHTX00446 (01)00840682121729(11)240600(21)FBMHTX00446 FBXXTE01644 (01)00840682121729(11)221200(21)FBXXTE01644 FBMHTX00464 (01)00840682121729(11)240900(21)FBMHTX00464 FBXXTE02978 (01)00840682121729(11)240800(21)FBXXTE02978 F2XXTX00798 (01)00840682121729(11)240800(21)F2XXTX00798 FBXXTE02979 (01)00840682121729(11)240800(21)FBXXTE02979 FBXXTE01932 (01)00840682121729(11)230300(21)FBXXTE01932 FBXXTE02977 (01)00840682121729(11)240800(21)FBXXTE02977 FBXXTE02993 (01)00840682121729(11)240800(21)FBXXTE02993 FBHXTX00821 (01)00840682121729(11)230200(21)FBHXTX00821 F2XXTX00800 (01)00840682121729(11)240800(21)F2XXTX00800 FSXXTX00284 (01)00840682121729(11)220500(21)FSXXTX00284 FBXXTE00575 (01)00840682121729(11)201200(21)FBXXTE00575 FBMHTX00469 (01)00840682121729(11)240900(21)FBMHTX00469 FBXXTE02323 (01)00840682121729(11)230900(21)FBXXTE02323 FSXXTX00422 (01)00840682121729(11)230300(21)FSXXTX00422 FAHXTX00538 (01)00840682121729(11)240600(21)FAHXTX00538 FBXXTE02996 (01)00840682121729(11)240800(21)FBXXTE02996 FSXXTX00418 (01)00840682121729(11)230300(21)FSXXTX00418 FBXXTE01863 (01)00840682121729(11)230300(21)FBXXTE01863 FBMHTX00453 (01)00840682121729(11)240800(21)FBMHTX00453 FBMHTX00329 (01)00840682121729(11)230200(21)FBMHTX00329 FAXXTE01158 (01)00840682121729(11)240800(21)FAXXTE01158 FBXXTE02995 (01)00840682121729(11)240800(21)FBXXTE02995 FAXXTE01159 (01)00840682121729(11)240800(21)FAXXTE01159 F9XXXX00064 (01)00840682121729(11)191200(21)F9XXXX00064 FBXXTE02980 (01)00840682121729(11)240800(21)FBXXTE02980 FBXXTE02981 (01)00840682121729(11)240800(21)FBXXTE02981 FBXXTE02982 (01)00840682121729(11)240800(21)FBXXTE02982 FBXXTE02983 (01)00840682121729(11)240800(21)FBXXTE02983 FBXXTE02984 (01)00840682121729(11)240800(21)FBXXTE02984 FBXXTE02986 (01)00840682121729(11)240800(21)FBXXTE02986 FBXXTE02987 (01)00840682121729(11)240800(21)FBXXTE02987 FBMHTX00456 (01)00840682121729(11)240800(21)FBMHTX00456 FBMHTX00449 (01)00840682121729(11)240700(21)FBMHTX00449 F9XXTX00329 (01)00840682121729(11)240800(21)F9XXTX00329
Other Recalls from GE OEC Medical Systems, Inc
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-0703-2025 | Class II | OEC 3D REF Image-Intensified Fluoroscopic X... | Nov 21, 2024 |
| Z-0705-2025 | Class II | OEC 9900 REF Image-Intensified Fluoroscopic... | Nov 21, 2024 |
| Z-0706-2025 | Class II | OEC 9800 REF Image-Intensified Fluoroscopic... | Nov 21, 2024 |
| Z-2277-2023 | Class II | OEC 9900 Systems with 9-inch Image Intensifier | May 15, 2023 |
| Z-2279-2023 | Class II | Field Upgrade Kits: P/N 5451208 RIU, 9 INCH, TO... | May 15, 2023 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.