OEC Elite and OEC 3D Mobile C-Arms Exceed X-Ray Field Size Specification
GE Medical Systems is notifying healthcare facilities that certain OEC Elite and OEC 3D Mobile C-arm systems have X-ray field sizes exceeding the 4% Source to Image Distance specification. No illnesses or injuries have been reported.
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: FDA Class II medical device recall involving X-ray systems with specification deviations that could result in unintended radiation exposure. No illnesses or injuries have been reported. Classified as risk-of-harm medical device without reported injury, meeting High severity criteria.
Plain-English summary
GE Medical Systems, LLC has issued a notification regarding certain OEC Elite and OEC 3D Mobile C-arm systems. These fluoroscopic imaging devices are used in operating rooms and intervention suites to provide real-time X-ray images during surgical and diagnostic procedures. The recall addresses a technical specification issue where some systems have X-ray field sizes that exceed the manufacturer's 4% Source to Image Distance (SID) specification limit.
When X-ray field size exceeds the specified limit, the radiation field extends beyond the intended area, potentially exposing unintended anatomical structures to X-rays. This represents a patient safety concern as it may result in unnecessary radiation exposure during procedures. No injuries or illnesses attributable to this issue have been reported to the FDA.
The recall affects 3,472 total OEC Elite and OEC 3D Mobile C-arm systems (2,919 in the United States and 553 outside the U.S.). Two populations are affected: systems specifically listed in the recall notice that potentially exceed the 4% SID field size limit, and systems not listed but lacking documented acceptance limits for X-ray field size measurement in their service manuals.
Healthcare providers operating these systems should consult GE Medical Systems and review the complete list of affected serial numbers. Facilities should work with GE or an authorized representative to verify their systems' X-ray field size compliance and implement any necessary corrections.
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
- Hazard
- radiation-exposure
- x-ray-field-size-deviation
Distribution
Distribution scope not specified by the agency.
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