Agency classClass IIOur severity:High FDA (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.

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 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…
Manufacturer: GE OEC Medical Systems, Inc
Category: Medical Device — Diagnostic Imaging Equipment
Hazard: oil-leak
equipment-failure
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 →

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
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Fluoroscopic X-Ray System Recalled for Insufficient X-Ray Tube Sealing
FDA (Devices) · 2024-12-25
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OEC 3D Mobile Fluoroscopic X-Ray System Tube Sealing Defect Recall
FDA (Devices) · 2024-12-25
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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