PlainRecalls
FDA Devices Moderate Class II Terminated

OEC¿ UroView 2800. The UroView 2800 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-0192-2015

Product Description

OEC¿ UroView 2800. The UroView 2800 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
2
Distribution
Worldwide Distribution.
Location
Salt Lake City, UT

Frequently Asked Questions

What product was recalled?
OEC¿ UroView 2800. The UroView 2800 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: 2.
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-0192-2015.