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U.S. Department of Health and Human Services

Class 2 Device Recall GE OEC 9800

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 Class 2 Recall
GE OEC 9800
see related information
Date Posted August 22, 2012
Recall Status1 Terminated on January 28, 2013
Recall Number Z-2240-2012
Recall Event ID 62691
Premarket Notification
510(K) Numbers
K021049  K022069  K024012 
Product Classification System, X-Ray, Fluoroscopic, Image-Intensified - Product Code JAA
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 imaging applications at the physician's discretion.
Code Information Model Number HDS721616PLAT80; GE Healthcare part number 5304649.
Recalling Firm/
Manufacturer
GE OEC Medical Systems, Inc
384 Wright Brothers Dr
Salt Lake City, Utah 84116-2862
Manufacturer 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.
FDA Determined
Cause 2
DESIGN: 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 version 29. This will remedy the potential for data loss, data mix, and system file corruption of the hard drives. For further questions please call 800-874-7378 Option 8.
Quantity in Commerce 3,595 units
Distribution Worldwide Distribution -- USA (nationwide)
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = JAA and Original Applicant = GE OEC MEDICAL SYSTEMS
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