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U.S. Department of Health and Human Services

Class 2 Device Recall OEC 9900

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 Class 2 Recall
OEC 9900
see related information
Date Posted September 29, 2008
Recall Status1 Open
Recall Number Z-0368-2008
Recall Event ID 49536
Product Classification System, X-Ray, Fluoroscopic, Image-Intensified - Product Code JAA
Product GE Healthcare OEC 9900 mobile fluoroscopic x-ray system
Code Information All codes
Recalling Firm/
Manufacturer
OEC Medical Systems, Inc
384 Wright Brothers Dr
Salt Lake City, Utah 84116-2862
Manufacturer Reason
for Recall
Possible overexposure: Failure to apply the entrance exposure rate (EER) tube current limit calibration to the automatic exposure rate (AER) control system when the anatomical profile mode is changed from the default selection to another selection. Manual technique modes are not affected.
FDA Determined
Cause 2
RADIATION CONTROL FOR HEALTH AND SAFETY ACT: Radiation Control for Health and Safety Act
Action GE OEC sent a letter to customers December 15, 2007, and scheduled field representative visits for corrective software solution installation.
Quantity in Commerce 710
Distribution Worldwide distribution: USA, Finland, Netherlands, Germany, Switzerland, France, United Kingdom, Australia, Italy, Ireland, Spain, Sweden, Belgium, New Zealand, China, Singapore, Poland, Norway, and India.
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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