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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 Device Recall OEC 9800 Plus (Fluorotrak) see related information
Date Initiated by Firm March 01, 2007
Date Posted September 28, 2007
Recall Status1 Terminated 3 on May 01, 2012
Recall Number Z-0682-2007
Recall Event ID 37498
510(K)Number K024012  K022069  K021049  
Product Classification Image-intensified fluoroscopic x-ray system - 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 UT 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		 Other
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 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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