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U.S. Department of Health and Human Services

Class 2 Device Recall OEC 9900

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  Class 2 Device Recall OEC 9900 see related information
Date Initiated by Firm December 14, 2007
Date Posted September 29, 2008
Recall Status1 Terminated 3 on April 13, 2012
Recall Number Z-0368-2008
Recall Event ID 49536
Product Classification fluoroscopic x-ray system - 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 UT 84116-2862
For Additional Information Contact
801-328-9300
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		 Software design
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 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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