892.1650 Image-intensified fluoroscopic x-ray system; the device is designed to provide fluorosco...
FDA Recall #Z-2240-2012 — Class II — November 6, 2009
Product Description
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.
Reason for Recall
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.
Recalling Firm
GE OEC Medical Systems, Inc — Salt Lake City, UT
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
3,595 units
Distribution
Worldwide Distribution -- USA (nationwide)
Code Information
Model Number HDS721616PLAT80; GE Healthcare part number 5304649.
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated