FlexiView 8800 Digital Mobile Imaging System. The FlexiView 8800 Digital Mobile Imaging System is designed to provide fluoroscopic and spot film, imaging of the patient during diagnostic, surgical and interventional procedures.
- Company
- Ge Oec Medical Systems, Inc
- Recall Initiated
- October 3, 2014
- Posted
- November 7, 2014
- Terminated
- March 23, 2015
- Recall Number
- Z-0194-2015
- Quantity
- 5
- Firm Location
- Salt Lake City, UT
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.
Distribution
Worldwide Distribution.
Lot / Code Info
Serial No: 3120PU3, 4851PU2, 5640PU8, 6052PU5, FIB0064
Root Cause
Component design/selection
Action Taken
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.