OEC 8800 Flexiview designed to provide fluoroscopic and spot-film imaging of the patient during d...
FDA Recall #Z-2027-2012 — Class II — November 19, 2007
Product Description
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.
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.
Recalling Firm
GE OEC Medical Systems, Inc — Salt Lake City, UT
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
1349 units
Distribution
Worldwide Distribution.
Code Information
Part numbers: OEC 8800 All serial numbers.
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated