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U.S. Department of Health and Human Services

Class 2 Device Recall OEC 9800

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 Class 2 Recall
OEC 9800
see related information
Date Posted March 22, 2007
Recall Status1 Terminated on June 26, 2007
Recall Number Z-0556-2007
Recall Event ID 37322
Premarket Notification
510(K) Numbers
K021049  K022069  K024012 
Product Classification System, X-Ray, Fluoroscopic, Image-Intensified - Product Code JAA
Product OEC 9800 Fluoroscopic X-ray System, Model Number A349855, GE Healthcare, Surgery.
Code Information Model Number A349855. 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, Utah 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
PRODUCTION CONTROLS: Packaging Process Control
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 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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