The Recall Desk
HighFDA (Devices)·Z-0706-2025·Announced 2024-12-25

GE OEC 9800 X-Ray System Recalled for Insufficient Tube Sealing

GE OEC 9800 fluoroscopic X-ray systems are recalled due to insufficient sealing of X-ray tubes, which can result in oil leaks and loss of imaging capability. 25 systems distributed in the U.S. and internationally are 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 a risk-of-harm medical device with a manufacturing defect resulting in potential oil leakage and functional loss of imaging capability. No injuries or illnesses have been reported. As an FDA Class II recall without hospitalization reports, and with stated potential (not actual) harm, the score applies the rubric criterion for 'risk-of-harm products where injury has not yet been reported.'

Plain-English summary

The OEC 9800 REF Image-Intensified Fluoroscopic X-Ray System is a mobile medical device designed for diagnostic, surgical, and interventional procedures including cholangiography, endoscopy, urologic, orthopedic, neurologic, vascular, cardiac, critical care, and emergency room applications. The recall affects 25 systems.

GE OEC Medical Systems, Inc. identified a manufacturing defect involving insufficient sealing of the X-ray tubes. This defect can result in an oil leak and potential loss of fluoroscopic imaging capability.

The affected systems have been distributed throughout the United States and internationally to Australia, Brazil, Canada, Chile, Costa Rica, India, Italy, Philippines, Poland, Portugal, Sweden, Switzerland, and the United Kingdom.

Healthcare facilities with affected systems should contact the manufacturer for guidance on remediation.

The recalled product

Product
OEC 9800 REF Image-Intensified Fluoroscopic X-Ray System, Mobile. The Series OEC 9800 is designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical and interventional procedures. Clinical application may include cholangiography, endoscop
Manufacturer
GE OEC Medical Systems, Inc
Category
Medical Device — Diagnostic Imaging / X-Ray Equipment
Hazard
Affected units
25

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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