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U.S. Department of Health and Human Services

Class 2 Device Recall OEC Miniview 6800 Mobile fluoroscopic xray system

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  Class 2 Device Recall OEC Miniview 6800 Mobile fluoroscopic xray system see related information
Date Initiated by Firm May 24, 2007
Date Posted July 03, 2007
Recall Status1 Terminated 3 on June 02, 2008
Recall Number Z-0928-2007
Recall Event ID 38272
510(K)Number K992506  
Product Classification Fluoroscopic x-ray system - Product Code JAA
Product OEC Miniview 6800 mobile fluoroscopic x-ray system, GE Healthcare, Surgery, Salt Lake City, Utah.
Code Information Serial numbers in the range of 86-0032 to 86-2161
Recalling Firm/
Manufacturer		 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 did not have the required labeling to indicate Air Kerma Rate and cumulative Air Kerma during fluoroscopic procedures
FDA Determined
Cause 2		 Other
Action Consignees were notified by letter on 05/24/2007 and advised that a service representative would be contacting them for installation of the required label and to provide them with an update to their user's manuals.
Quantity in Commerce 811 systems
Distribution Worldwide; USA including VA facilities in AK, CA, ID, MD, MI, NY and OR. Military distribution to CA, CO, CT, FL, GA, KS, LA, MS, OH, OK, TX, VA and Iraq. Foreign distribution to Austria, Australia, Belgium, Canada, China, Denmark, Finland, France, Germany, Hong Kong, Israel, Italy, Japan, Korea, Malaysia, Netherlands, Norway, Portugal, Singapore, South Africa, Spain, Sweden, Switzerland, Taiwan and UK.
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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