Series OEC 9800. The Series OEC 9800 is designed to provide fluoroscopic and spot-film imaging of the patient,during diagnostic, surgical and interventional procedures.
Recall
- Recall Number
- Z-0195-2015
- Event Number
- 69474
- Firm
- GE OEC Medical Systems, Inc
- FEI Number
- 1720753
- Product Code
- OWB
- Status
- Terminated
- Root Cause
- Component design/selection
- Initiated
- October 3, 2014
- Posted
- November 7, 2014
- Terminated
- March 23, 2015
- Address
- 384 Wright Brothers Dr, Salt Lake City, UT, 84116-2862
Description
Series OEC 9800. The Series OEC 9800 is designed to provide fluoroscopic and spot-film imaging of the patient,during diagnostic, surgical and interventional procedures.
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.
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.
Worldwide Distribution.
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