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U.S. Department of Health and Human Services

Class 2 Device Recall OEC 9800 Plus (Fluorotrak)

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 Class 2 Recall
OEC 9800 Plus (Fluorotrak)
see related information
Date Posted September 28, 2007
Recall Status1 Open
Recall Number Z-0682-2007
Recall Event ID 37498
Premarket Notification
510(K) Numbers
K003837  K021049  K022069  K024012  K041932 
Product Classification System, X-Ray, Fluoroscopic, Image-Intensified - Product Code JAA
Product OEC 9800 Plus (Fluorotrak), Image-intensified fluoroscopic x-ray system, GE Healthcare, Salt Lake City, UT.
Code Information Serial number 8S-2339-N.
Recalling Firm/
Manufacturer
GE OEC Medical Systems, Inc
384 Wright Brothers Dr
Salt Lake City, Utah 84116-2862
For Additional Information Contact Karen Tolson
847-501-1884
Manufacturer Reason
for Recall
During routine service, primary and/or secondary collimators may not have been properly reinstalled.
FDA Determined
Cause 2
PRODUCTION CONTROLS: Process Control
Action Customers were notified by letter on 03/01/2007. They were told to continue using the machines and that an inspection would be scheduled immediately to verify that collimators had been correctly installed.
Quantity in Commerce 1
Distribution Nationwide and Germany.
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.
510(K) Database 510(K)s with Product Code = JAA and Original Applicant = GE OEC MEDICAL SYSTEMS
510(K)s with Product Code = JAA and Original Applicant = GE OEC MEDICAL SYSTEMS, INC.
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