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U.S. Department of Health and Human Services

Class 2 Device Recall GE OEC 9900GSP Elite Fluoroscopes

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 Class 2 Recall
GE OEC 9900GSP Elite Fluoroscopes
see related information
Date Posted January 20, 2010
Recall Status1 Terminated on April 23, 2012
Recall Number Z-0005-2010
Recall Event ID 53491
Product Classification System, X-Ray, Fluoroscopic, Image-Intensified - Product Code JAA
Product GE OEC 9900 Elite GSP Fluoroscopes To produce mobile fluoroscopic images of human anatomy.
Code Information All associated serial numbers
Recalling Firm/
Manufacturer
Ge Healthcare
384 Wright Brothers Dr
Salt Lake City, Utah 84116-2862
For Additional Information Contact Deena Pease
801-536-4952
Manufacturer Reason
for Recall
A software defect - may result in a false indication and warning on the OEC 9900 Workstation and C-arm display that the X-Ray tube Anode is over-heated. This will also cause the displayed air kerma rate and cumulative air kerma to be inaccurate.
FDA Determined
Cause 2
RADIATION CONTROL FOR HEALTH AND SAFETY ACT: Radiation Control for Health and Safety Act
Action An Important Electronic Product Radiation Warning letter will be sent to customers identifying the issues, interim solution, and permanent solution. Questions or concerns are to be directed to the GEHC OEC service team at 1-800-874-7378.
Quantity in Commerce 1411 units total
Distribution Nationwide and Canadian Distribution
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.
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