The Recall Desk
HighFDA (Devices)·Z-0704-2025·Announced 2024-12-25

Fluoroscopic X-Ray System Recalled for Insufficient X-Ray Tube Sealing

GE OEC Elite mobile fluoroscopic X-ray systems are recalled due to insufficient sealing of X-ray tubes, which can cause oil leaks and loss of imaging capability. Approximately 100 systems have been affected.

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 of a critical medical device with a manufacturing defect that compromises device function through potential oil leakage and loss of imaging capability. Although no illnesses or injuries have been reported, the device represents a risk-of-harm product used in diagnostic and surgical settings where imaging failure could impact patient care.

Plain-English summary

GE OEC Medical Systems, Inc. is recalling the OEC Elite REF mobile fluoroscopic X-ray system, a mobile C-arm device used in hospitals and surgical settings to provide real-time imaging during diagnostic, interventional, and surgical procedures.

The recall is due to a manufacturing defect in which X-ray tubes may have insufficient sealing. This defect can allow oil to leak from the tubes and can result in loss of fluoroscopic imaging capability, rendering the device unable to function as intended.

Approximately 100 systems have been distributed across the United States and internationally (including Australia, Brazil, Canada, Chile, Costa Rica, India, Italy, Philippines, Poland, Portugal, Sweden, Switzerland, and the United Kingdom). Affected units are identified by specific lot and serial numbers available from the FDA.

Healthcare facilities with affected devices should contact the manufacturer immediately for inspection, repair, or replacement options. The device should be discontinued from use until remediation is completed.

The recalled product

Product
OEC Elite REF Image-Intensified Fluoroscopic X-Ray System, Mobile. 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
Manufacturer
GE OEC Medical Systems, Inc
Category
Medical Device — Mobile Fluoroscopic C-Arm
Hazard
Affected units
100

Distribution

Distributed in 45 states:

Part of a larger recall action

This product is one of 4 recalled by GE OEC Medical Systems, Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 4 products in this recall →

Related recalls

Same manufacturer · GE OEC Medical Systems, Inc

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Same hazard · oil leak

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