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U.S. Department of Health and Human Services

Class 2 Device Recall GE Healthcare OEC 9900 Elite

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  Class 2 Device Recall GE Healthcare OEC 9900 Elite see related information
Date Initiated by Firm December 27, 2016
Date Posted January 20, 2017
Recall Status1 Terminated 3 on July 12, 2018
Recall Number Z-1060-2017
Recall Event ID 76074
510(K)Number K120613  K122234  
Product Classification Interventional fluoroscopic x-ray system - Product Code OWB
Product OEC 9900 Elite. MDL Numbers: D148942, D155043
Code Information Manufactured from Oct 2005 to present
Recalling Firm/
Manufacturer		 GE OEC Medical Systems, Inc
384 N Wright Brothers Dr
Salt Lake City UT 84116-2862
For Additional Information Contact Deena Pease
801-536-4952
Manufacturer Reason
for Recall		 GE Healthcare Surgery announces a voluntary field action for the OEC 9800 and OEC 9900 Elite due to additional supplementation to the user documentation to include areas for enhanced planned maintenance and component replacement frequencies.
FDA Determined
Cause 2		 Packaging change control
Action The customer communication is expected to begin distribution in January 2017. Consignees will be notified of the availability of the Operator Manual supplement via a letter. No product is being returned.
Quantity in Commerce 26,256 total
Distribution Worldwide including govt/VA/military and foreign consignees.
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 = OWB and Original Applicant = GE HEALTHCARE SURGERY GE OEC MEDICAL SYSTEMS, INC
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