The Recall Desk
HighFDA (Devices)·Z-0705-2025·Announced 2024-12-25

OEC 9900 Mobile Fluoroscopic X-Ray System Recall for Sealing Defect

GE OEC Medical Systems is recalling 78 OEC 9900 Elite mobile fluoroscopy systems due to insufficient sealing of X-ray tubes. The defect can result in oil leaks and loss of fluoroscopic imaging capability.

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 Class II recall of medical imaging equipment with an explicit manufacturing defect that can cause oil leaks and loss of critical diagnostic capability. No illnesses or injuries have been reported, but the product is inherently risk-of-harm, meeting the rubric criterion for High severity.

Plain-English summary

The OEC 9900 Elite is an image-intensified fluoroscopic X-ray system used in hospitals for diagnostic surgical and interventional procedures, including cholangiography, endoscopy, urologic, orthopedic, neurologic, vascular, cardiac, critical care, and emergency room procedures.

GE OEC Medical Systems is recalling approximately 78 systems due to a manufacturing issue involving insufficient sealing of X-ray tubes. This defect can result in potential oil leaks and loss of fluoroscopic imaging capability, which would prevent the system from functioning properly.

The affected systems were distributed throughout the U.S. and in Australia, Brazil, Canada, Chile, Costa Rica, India, Italy, Philippines, Poland, Portugal, Sweden, Switzerland, and the United Kingdom. Affected lot and serial numbers are listed in the FDA recall notice.

Healthcare facilities that operate affected OEC 9900 systems should stop using them and contact GE OEC Medical Systems for guidance on repair, replacement, or remediation. Consult the full FDA recall notice for complete information about affected serial numbers and recommended actions.

The recalled product

Product
OEC 9900 REF Image-Intensified Fluoroscopic X-Ray System, Mobile. The OEC 9900 Elite mobile fluoroscopy system is designed to provide fluoroscopic and spot-film images of the patient during diagnostic surgical and interventional procedures. Examples of clinical application ma
Manufacturer
GE OEC Medical Systems, Inc
Category
Medical Device — Diagnostic Imaging Equipment
Hazard
Affected units
78

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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