Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
892.1650 Image-intensified fluoroscopic x-ray system Recalled by GE OEC Medical Systems, Inc Due to GE OEC is recalling certain 9800 Image Intensified...
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
892.1650 Image-intensified fluoroscopic x-ray system; the device is designed to provide fluoroscopic and spot film imaging of the patient during diagnostic surgical and interventional procedures. The systems include features specifically designed for use in diagnostic and interventional cardiac imaging procedures, and are also intended for cholangiography, endoscopic, urologic, orthopedic, neurologic, vascular, critical care and emergency room procedures. The systems may be used for other imaging applications at the physician's discretion.
Quantity: 3,595 units
Why Was This Recalled?
GE OEC is recalling certain 9800 Image Intensified Flouroscopic x-ray systems due to customer complaint analysis showing that a replacement Hitachi 160 GB Hard Drive, when installed on certain models is susceptible of causing unanticipated system shut downs, no boots, data loss or data mix, or unexpected hard drive corruption.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
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