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U.S. Department of Health and Human Services

Class 2 Device Recall Mini View (GE) Mobile Carm fluoroscopic xray system.

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  Class 2 Device Recall Mini View (GE) Mobile Carm fluoroscopic xray system. see related information
Date Initiated by Firm March 28, 2006
Date Posted September 30, 2006
Recall Status1 Terminated 3 on July 25, 2011
Recall Number Z-0704-06
Recall Event ID 34990
510(K)Number K992506  
Product Classification X ray system - Product Code JAA
Product MiniView 6800 Digital Mobile C-arm fluoroscopic x-ray system.
Code Information All MiniView 6800 systems.
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		 Radiation exposure rate could exceed specifications during fluoroscopic x-ray procedure.
FDA Determined
Cause 2		 Other
Action Consignees were notified by letter prior to 04/28/2006.
Quantity in Commerce 534 units (Domestic), 125 (Intl)
Distribution Nationwide.
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 DEC MEDICAL SYSTEMS
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