Date Initiated by Firm | October 03, 2014 |
Date Posted | November 07, 2014 |
Recall Status1 |
Terminated 3 on March 23, 2015 |
Recall Number | Z-0192-2015 |
Recall Event ID |
69474 |
510(K)Number | K993687 |
Product Classification |
Interventional fluoroscopic x-ray system - Product Code OWB
|
Product | OEC 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 Contact | Deena 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 |
Action | On 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 Commerce | 2 |
Distribution | Worldwide Distribution. |
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.
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510(K) Database | 510(K)s with Product Code = OWB
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