Recall Z-2240-2012 ยท JAA System, X-Ray, Fluoroscopic, Image-Intensified
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, neurol
| Date | Aug 22, 2012 (initiated Nov 6, 2009) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Device Design |
| Action | GE OEC sent a Urgent Recall Notice dated November 6, 2009, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The notification advised them that GE Healthcare had identified a potential safety issue associated with a "Significant increase on Data Loss, Data Mix, and System file corruption of the Hard Drives" on the 9800 Systems. The field correction consisted of installing a "Smart Power Switch" between the power control PCB and the system power switch on 9800 Systems with a Celeron single board computer and software ve |
| Quantity | 3,595 units |
| Distribution | Worldwide Distribution -- USA (nationwide) |
| FDA record | Open on fda.gov |