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U.S. Department of Health and Human Services

Class 2 Device Recall OEC FlexiView 8800

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  Class 2 Device Recall OEC FlexiView 8800 see related information
Date Initiated by Firm February 21, 2017
Date Posted February 27, 2017
Recall Status1 Terminated 3 on April 24, 2017
Recall Number Z-1469-2017
Recall Event ID 76568
510(K)Number K003837  
Product Classification Image-intensified fluoroscopic x-ray system, mobile - Product Code OXO
Product OEC FlexiView 8800, Digital Mobile Imaging System, GE Medical Systems
Code Information OEC FlexiView 8800 systems that had NEMA 5-15 15 Amp power cords replaced between January 28, 2016 and November 23, 2016.
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		 OEC FlexiView 8800 workstation power cable assembly issue which can result in a loss of imaging functionality due to intermittent power cord failures.
FDA Determined
Cause 2		 Process control
Action On February 21, 2017, an Urgent Medical Device Correction letter was sent to one consignee with an affected unit; a field service representative hand delivered the customer communication.
Quantity in Commerce 1
Distribution One consignee in CA.
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 = OXO and Original Applicant = GE OEC MEDICAL SYSTEMS
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