GE OEC Recalls 9800 Fluoroscopic X-Ray Systems Due to Hard Drive Defects
GE OEC is recalling 9800 fluoroscopic x-ray systems because a replacement hard drive can cause system shutdowns, data loss, or data corruption.
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: The recall involves a medical device with a defect that can cause system shutdowns and data loss, which poses a risk of harm to patients during procedures, but no injuries or illnesses have been reported.
Plain-English summary
GE OEC Medical Systems, Inc. is recalling certain 9800 Image Intensified Fluoroscopic x-ray systems. The recall is based on customer complaint analysis indicating that a replacement Hitachi 160 GB Hard Drive, when installed on certain models, is susceptible to causing unanticipated system shutdowns, no boots, data loss or data mix, or unexpected hard drive corruption.
The affected systems are designed to provide fluoroscopic and spot film imaging of patients during diagnostic surgical and interventional procedures. These systems are intended for use in diagnostic and interventional cardiac imaging, as well as cholangiography, endoscopic, urologic, orthopedic, neurologic, vascular, critical care, and emergency room procedures.
The recall involves 3,595 units distributed worldwide, including nationwide distribution in the United States. The specific model number is HDS721616PLAT80, and the GE Healthcare part number is 5304649. Healthcare facilities should contact GE OEC Medical Systems for further instructions on how to address the hard drive issue.
The recalled product
- 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 interv
- Manufacturer
- GE OEC Medical Systems, Inc
- Hazard
- Affected units
- 3,595
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Model Number HDS721616PLAT80
- GE Healthcare part number 5304649.
Distribution
Distributed nationwide across the United States.
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