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U.S. Department of Health and Human Services

Class 2 Device Recall OEC 9900 Elite

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  Class 2 Device Recall OEC 9900 Elite see related information
Date Initiated by Firm March 01, 2007
Date Posting Updated September 28, 2007
Recall Status1 Terminated 3 on May 01, 2012
Recall Number Z-0676-2007
Recall Event ID 37498
510(K)Number K041932  
Product Classification Image-intensified fluoroscopic x-ray system - Product Code JAA
Product OEC 9900 Elite image-intensified fluoroscopic x-ray system, GE Healthcare, Salt Lake City, UT.
Code Information Serial Numbers: E2-0019, E2-0028, E2-0064, E2-0142, E2-0156, E2-0170, E2-0180, E2-0213, E9-0008, E9-0040-G, E9-0103, E9-0029, ES-0060, ES-0088, ES-0096, ES-0099, E9-0150, E9-0152, E9-0158.
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 19 units
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, INC.
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