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U.S. Department of Health and Human Services

Enforcement Report - Week of August 29, 2012

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Event Detail

Event ID 62691
Product Type Devices
Status Ongoing
Recalling Firm GE OEC Medical Systems, Inc
City Salt Lake City
State UT
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2009-11-06
Initial Firm Notification of
Consignee or Public
Distribution Pattern Worldwide Distribution -- USA (nationwide)

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
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. Model Number HDS721616PLAT80; GE Healthcare part number 5304649. Class II 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. 3,595 units Z-2240-2012