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U.S. Department of Health and Human Services

Class 2 Device Recall Fluoro CArm Xray system.

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  Class 2 Device Recall Fluoro CArm Xray system. see related information
Date Initiated by Firm August 16, 2006
Date Posted September 30, 2006
Recall Status1 Terminated 3 on July 27, 2011
Recall Number Z-1302-06
Recall Event ID 36099
510(K)Number K024012  
Product Classification X-ray - Product Code JAA
Product GE OEC 9800 Fluoro C-Arm X-ray System, GE OEC Medical Systems Inc.
Code Information All units
Recalling Firm/
Manufacturer		 GE 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		 X-ray systems could provide output which exceeds the 20 R/minute limit.
FDA Determined
Cause 2		 Other
Action Consignees were notified by certified letter on 08/14-15/2006.
Quantity in Commerce 8,266 units (US), 2,664 units (foreign)
Distribution Worldwide
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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