Reported Jun 18, 2025 · Ongoing
OEC Elite: The OEC Elite mobile C-arm is intended to provide fluoroscopic and digital spot images of the patient…
GE Medical Systems, LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: GE Medical Systems, LLC · 3000 N Grandview Blvd · Waukesha, WI · 53188-1615
Is this the product you have?
- OEC EliteThe 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
- Lot codes and dates
- Two populations are potentially affected by this notification. 1. Listed in Appendix A -
- OEC Elite Mobile C-arm Systems (GTIN00001234567895)
- and OEC 3D Mobile C-arm Systems (GTIN00195278096944) that potentially have an X-ray field size greater than the 4% SID limit and do not contain the acceptance limit for the X-ray field size measurement in the System Service Manual. 2. Systems NOT listed in Appendix A -
- OEC Elite Mobile C-arm Systems (GTIN00001234567895)
- and OEC 3D Mobile C-arm Systems (GTIN00195278096944) that are within the allowed SID limit. However, the acceptance limit for the X-ray field size measurement is not stated in the System Service Manual. Appendix A Serial NumbersFBX
2,658 of 2,658 codes
FAHXTX00002FAHXTX00005FAHXTX00014FAHXTX00018FAHXTX00019FAHXTX00020FAHXTX00024FAHXTX00028FAHXTX00034FAHXTX00037FAHXTX00043FAHXTX00052FAHXTX00063FAHXTX00066FAHXTX00068FAHXTX00070FAHXTX00075FAHXTX00078FAHXTX00079FAHXTX00080FAHXTX00081FAHXTX00083FAHXTX00092FAHXTX00093FAHXTX00097FAHXTX00110FAHXTX00111FAHXTX00112FAHXTX00114FAHXTX00115FAHXTX00116FAHXTX00117FAHXTX00118FAHXTX00119FAHXTX00120FAHXTX00121FAHXTX00122FAHXTX00124FAHXTX00125FAHXTX00135FAHXTX00137FAHXTX00138FAHXTX00151FAHXTX00152FAHXTX00155FAHXTX00156FAHXTX00162FAHXTX00163FAHXTX00166FAHXTX00170FAHXTX00171FAHXTX00177FAHXTX00178FAHXTX00188FAHXTX00192FAHXTX00193FAHXTX00202FAHXTX00204FAHXTX00211FAHXTX00212
- Amount recalled
- Total for both products: 3472 (2,919 US; 553 OUS)
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Why it was recalled
OEC Elite and OEC 3D Mobile C-Arms Exceeding 4% Source to Image Distance in X-ray Field.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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