Class II

Medical Device Recall: 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, intervent

GE Medical Systems, LLC · March 21, 2025

Reason for Recall

OEC Elite and OEC 3D Mobile C-Arms Exceeding 4% Source to Image Distance in X-ray Field.

Product Description

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.

Distribution

US and OUS

Quantity Affected

Total for both products: 3472 (2,919 US; 553 OUS)

Source: FDA (openFDA Device Enforcement)

Recall number: Z-1819-2025

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.