OEC 8800 Flexiview designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical and interventional procedures. The OEC 8800 is designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical and interventional procedures. Clinical applications may include cholangiography, endoscopic, urologic, orthopedic, neurologic, vascular, cardiac, critical care and emergency room procedures. The system may be used for other imaging applications at the physician's discretion.
- Company
- Ge Oec Medical Systems, Inc
- Recall Initiated
- November 19, 2007
- Posted
- July 18, 2012
- Terminated
- January 28, 2013
- Recall Number
- Z-2027-2012
- Quantity
- 1349 units
- Firm Location
- Salt Lake City, UT
Reason for Recall
Please be aware that this is not a new recall. The firm has taken action; but, due to administrative issues this recall is now being classified by the Agency. GE OEC recalled imaging devices OEC 9900, OEC 9800, and OEC 8800 as a result of an FDA inspection identifying that the vertical lift column power supply in the mainframe C-arm is defective and subject to early life failure.
Distribution
Worldwide Distribution.
Lot / Code Info
Part numbers: OEC 8800 All serial numbers.
Root Cause
Device Design
Action Taken
Please be aware that this is not a new recall. The firm has taken action; but, due to administrative issues this recall is now being classified by the Agency. GE Healthcare sent an"URGENT RECALL NOTICE" dated February 22, 2008 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. Contact the firm at 800-874-7378 for questions concerning this recall.