GE OEC Medical Systems, Inc 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 imag Recall
Class II: 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
Class II recall indicates potential for temporary health effects.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
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 imag
Brand
GE OEC Medical Systems, Inc
Lot Codes / Batch Numbers
Model Number HDS721616PLAT80, GE Healthcare part number 5304649.
Products Sold
Model Number HDS721616PLAT80; GE Healthcare part number 5304649.
GE OEC Medical Systems, Inc is recalling 892.1650 Image-intensified fluoroscopic x-ray system; the device is designed to provide fluoroscopic due to GE OEC is recalling certain 9800 Image Intensified Flouroscopic x-ray systems due to customer complaint analysis showing that a replacement Hitachi 16. This is a Class I recall, indicating a high risk of serious health consequences or death. Based on FDA medical device enforcement report.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
Healthcare providers and patients should stop using the device and contact the manufacturer for further instructions. Report problems to FDA MedWatch.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 12, 2026