Agency classClass IIOur severity:High FDA (Devices)·Z-0703-2025·Announced 2024-12-25

OEC 3D Mobile Fluoroscopic X-Ray System Tube Sealing Defect Recall

GE OEC Medical Systems is recalling 84 OEC 3D mobile fluoroscopic X-ray systems due to manufacturing defects in X-ray tube sealing that can cause oil leaks and loss of imaging capability.

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 device recall with a manufacturing defect affecting a critical-use medical device (surgical imaging system). Although no illnesses or injuries have been reported, the potential for imaging loss during surgical procedures and oil leaks presents a risk of harm in a professional medical setting.

Plain-English summary

GE OEC Medical Systems, Inc. is recalling 84 OEC 3D REF mobile fluoroscopic X-ray systems due to a manufacturing issue involving insufficient sealing of the X-ray tubes.

The systems are used to provide fluoroscopic images and volumetric reconstructions during diagnostic, interventional, and surgical procedures. The manufacturing defect can result in oil leaks and potential loss of fluoroscopic imaging capability, which could compromise the device's ability to provide real-time imaging guidance during these procedures.

The recalled systems were distributed throughout the United States (including Alaska, Hawaii, and Guam) and internationally to Australia, Brazil, Canada, Chile, Costa Rica, India, Italy, Philippines, Poland, Portugal, Sweden, Switzerland, and the United Kingdom.

Healthcare facilities and physicians using affected systems should contact GE OEC Medical Systems, Inc. for instructions regarding remediation options.

The recalled product

Product: OEC 3D REF Image-Intensified Fluoroscopic X-Ray System, Mobile. The OEC 3D is a mobile fluoroscopic C-Arm imaging system used to assist trained surgeons and other qualified physicians. The system is used to provide fluoroscopic Xray images and volumetric reconstructions…
Manufacturer: GE OEC Medical Systems, Inc
Category: Medical Device — Surgical Imaging / Fluoroscopy
Hazard: oil-leak
imaging-failure
Affected units: 84

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
Fluoroscopic X-Ray System Recalled for Insufficient X-Ray 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 Flexiview 8800 Image Intensifier Risks Detachment During Movement
FDA (Devices) · 2023-08-09
High
Image intensifier detachment hazard in OEC fluoroscopy imaging systems
FDA (Devices) · 2023-08-09

Same hazard · oil leak