Agency classClass IIOur severity:High FDA (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.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

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: oil-leak
imaging-failure
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 →

Same manufacturer · GE OEC Medical Systems, Inc

See all →

High
GE OEC 9800 X-Ray System Recalled for Insufficient Tube Sealing
FDA (Devices) · 2024-12-25
High
OEC 9900 Mobile Fluoroscopic X-Ray System Recall for Sealing Defect
FDA (Devices) · 2024-12-25
High
OEC 3D Mobile Fluoroscopic X-Ray System Tube Sealing Defect Recall
FDA (Devices) · 2024-12-25
High
Medical X-ray Systems Image Intensifier Detachment Injury Risk
FDA (Devices) · 2023-08-09
High
OEC 9800 Fluoroscopy Systems Image Intensifier May Detach and Fall
FDA (Devices) · 2023-08-09

Same hazard · oil leak