Serious health hazard — there is a reasonable probability that use of or exposure to this product will cause serious adverse health consequences or death.
OEC 9800 Recalled by GE OEC Medical Systems, Inc Due to Please be aware that this is not a...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact GE OEC Medical Systems, Inc directly.
Affected Products
OEC 9800; OEC FluoroTrak 9800 Plus; OEC 9800 Plus; OEC 9800 MD Motorized C-arm System, 892.1650 Image-intensified fluoroscopic x-ray system. The OEC 9800 is designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical and interventional procedures. The system includes features specifically designed for use in diagnostic and interventional cardiac imaging procedures and is also intended for cholangiography, endoscopic, urologic orthopedic, neurologic, vascular, critical care and emergency room procedures. It may be used for other imaging applications at the physician's discretion.
Quantity: 8214 units
Why Was This Recalled?
Please be aware that this is not a new recall. The firm has taken action; but, due to administrative issues this recall is now being classified by the Agency. The vertical lift column power supply in the mainframe C-arm of the device is defective and subject to early life failure.
Where Was This Sold?
Worldwide distribution.
About GE OEC Medical Systems, Inc
GE OEC Medical Systems, Inc has 48 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report