GE OEC Medical Systems, Inc: Medical Device Recall in 2014 - (Recall #: Z-0194-2015)
Updated on March 25, 2026.
See the recall detail below. You can also see other recalls from the same firm in 2014.
Data Source: FDA.
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.
Product Classification:
Class II
Date Initiated: October 3, 2014
Date Posted: November 19, 2014
Recall Number: Z-0194-2015
Event ID: 69474
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.
Status: Terminated
Product Quantity: 5
Code Information:
Serial No: 3120PU3, 4851PU2, 5640PU8, 6052PU5, FIB0064
Distribution Pattern:
Worldwide Distribution.
Voluntary or Mandated:
Voluntary: Firm initiated