The Recall Desk
HighFDA (Devices)·Z-1819-2025·Announced 2025-06-18

OEC Elite and OEC 3D Mobile C-Arms X-ray Field Size Exceeds Limit

GE Medical Systems is recalling certain OEC Elite and OEC 3D mobile C-arm systems that may produce X-ray fields exceeding acceptable limits. Some units also lack proper acceptance limits in their service manuals.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is an FDA Class II recall involving a medical device used in surgical and interventional procedures. The hazard involves radiation exposure parameters (X-ray field size) exceeding acceptable limits, which presents a risk of patient harm, and the source explicitly states no illnesses or injuries have been reported, placing it at severity 3 per the rubric.

Plain-English summary

GE Medical Systems, LLC is recalling OEC Elite mobile C-arm systems (GTIN: 00001234567895) and OEC 3D mobile C-arm systems (GTIN: 00195278096944) due to X-ray field size concerns. These devices are used to provide fluoroscopic and digital spot images during diagnostic, interventional, and surgical procedures.

Two populations are affected. The first consists of systems listed in Appendix A that may have an X-ray field size exceeding the 4% Source to Image Distance (SID) limit and do not contain the acceptance limit for the X-ray field size measurement in the System Service Manual. The second population includes systems not listed in Appendix A that are within the allowed SID limit but are missing the stated acceptance limit for X-ray field size measurement in their System Service Manual.

A total of 3,472 units are potentially affected worldwide, including 2,919 units in the United States and 553 units outside the United States. Affected serial numbers are listed in Appendix A and include models with prefixes FAHXTX, FAHXXX, FAMHTX, FAMHXX, FAXXTE, FAXXTP, FAXXXE, FAXXXX, FBHVXX, FBHXTX, FBHXXX, FBMHDX, FBMHTX, FBMHXX, and FBXXTE.

Customers with affected units should contact GE Medical Systems for further instructions regarding inspection, repair, or other remedial actions.

The recalled product

Product
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.
Manufacturer
GE Medical Systems, LLC
Category
Medical Device — Imaging / Fluoroscopy
Hazard
  • x-ray-field-size
  • radiation-exposure

Distribution

Distribution scope not specified by the agency.

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