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U.S. Department of Health and Human Services

Class 2 Device Recall OEC 9800 Plus

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  Class 2 Device Recall OEC 9800 Plus see related information
Date Initiated by Firm February 09, 2007
Date Posting Updated March 22, 2007
Recall Status1 Terminated 3 on June 26, 2007
Recall Number Z-0558-2007
Recall Event ID 37322
510(K)Number K021049  K022069  K024012  
Product Classification Image-intensified fluoroscopic x-ray system. - Product Code JAA
Product OEC 9800 Plus Fluoroscopic X-ray System,
Code Information Serial numbers: 82-7092-MH, 89-0247-RC, 89-0599, 89-0972, 89-1001, 89-1685, 89-2383, 89-2877, 89-2907, 89-2987, 89-3330.
Recalling Firm/
Manufacturer
GE OEC Medical Systems, Inc
384 Wright Brothers Dr
Salt Lake City UT 84116-2862
For Additional Information Contact Ms. Karen Tolson
847-501-1884
Manufacturer Reason
for Recall
During routine service, a cover may have been installed without the required proper lead shielding.
FDA Determined
Cause 2
Other
Action Consignees were notified by telephone on 02/09/2007 and told to discontinue use of the units until they could be inspected by GE personnel. GE personnel visited all 8 sites on 02/12/2007.
Quantity in Commerce 11 units of all models
Distribution Nationwide to AL, AZ, IA, OH, TX, VA, and WV.
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.
510(K) Database 510(K)s with Product Code = JAA and Original Applicant = GE OEC MEDICAL SYSTEMS
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