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U.S. Department of Health and Human Services

Class 2 Device Recall OEC UroView 2800

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 Class 2 Device Recall OEC UroView 2800see related information
Date Initiated by FirmOctober 03, 2014
Date PostedNovember 07, 2014
Recall Status1 Terminated 3 on March 23, 2015
Recall NumberZ-0192-2015
Recall Event ID 69474
510(K)NumberK993687 
Product Classification Interventional fluoroscopic x-ray system - Product Code OWB
ProductOEC UroView 2800. The UroView 2800 is designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical. and interventional procedures
Code Information Serial No: P4-0490-R and P6-0705-L 
Recalling Firm/
Manufacturer		 GE OEC Medical Systems, Inc
384 Wright Brothers Dr
Salt Lake City UT 84116-2862
For Additional Information ContactDeena Pease
801-536-4952
Manufacturer Reason
for Recall		GE Healthcare initiated a field correction because prior revision of components were potentially installed on certain OEC 9800, FlexiView 8800, OEC MiniView 6800 and OEC UroView 2800 systems.
FDA Determined
Cause 2		Component design/selection
ActionOn October 3. 2014. GE Healthcare Surgery began distributing an Urgent Medical Device Correction letter to customers to inform them of the issue and provide instructions for immediate mitigation of the issue. The letter was sent to 3 titles at each facility affected: 1.1 Facility Administrator. 2.1 Director/Manager of Radiology and Radiologists, 3.) Radiology Department. Firm will track all service requests for the field action to completion. These service requests will document the inspection and component replacement (if applicable) on the affected units. Exceptions to completion of the service request will be recorded. Records of field action completion will be retained per our processes and procedures. No product is being returned.
Quantity in Commerce2
DistributionWorldwide Distribution.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = OWB
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