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U.S. Department of Health and Human Services

Class 2 Device Recall OEC 9800MD

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 Class 2 Device Recall OEC 9800MDsee related information
Date Initiated by FirmFebruary 09, 2007
Date PostedMarch 22, 2007
Recall Status1 Terminated 3 on June 26, 2007
Recall NumberZ-0559-2007
Recall Event ID 37322
510(K)NumberK021049 K022069 K024012 
Product Classification Image-intensified fluoroscopic x-ray system. - Product Code JAA
ProductOEC 9800MD Motorized C-arm System, 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 ContactMs. 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
ActionConsignees 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 Commerce11 units of all models
DistributionNationwide to AL, AZ, IA, OH, TX, VA, and WV.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = JAA
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