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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 Recall
OEC Miniview 6800 Mobile fluoroscopic xray system
see related information
Date Posted July 03, 2007
Recall Status1 Terminated on June 02, 2008
Recall Number Z-0928-2007
Recall Event ID 38272
Product Classification System, X-Ray, Fluoroscopic, Image-Intensified - 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, Utah 84116-2862
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
DESIGN: Labeling Design
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 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.
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