PlainRecalls
FDA Devices Moderate Class II Terminated

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.

Reported: November 19, 2014 Initiated: October 3, 2014 #Z-0194-2015

Product Description

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.

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.

Details

Units Affected
5
Distribution
Worldwide Distribution.
Location
Salt Lake City, UT

Frequently Asked Questions

What product was recalled?
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.. Recalled by GE OEC Medical Systems, Inc. Units affected: 5.
Why was this product recalled?
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.
Which agency issued this recall?
This recall was issued by the FDA Devices on November 19, 2014. Severity: Moderate. Recall number: Z-0194-2015.