Recall Z-1819-2025 ยท OXO Image-Intensified Fluoroscopic X-Ray System, Mobile
GE Medical Systems, LLC
OEC Elite: 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.
| Date | Jun 9, 2025 (initiated Mar 21, 2025) |
| Status | Open, Classified |
| Reason | OEC Elite and OEC 3D Mobile C-Arms Exceeding 4% Source to Image Distance in X-ray Field. |
| Root cause | Process control |
| Action | All impacted customers with receive a customer letter notifying them of the potential issue. GE HealthCare will send a field service engineer to perform measurements of the Xray field on the identified systems (listed in Appendix A of the customer letter). |
| Quantity | Total for both products: 3472 (2,919 US; 553 OUS) |
| Distribution | US and OUS |
| FDA record | Open on fda.gov |