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Recall Observatory FDA recall evidence

Device product

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.

Z-0194-2015

October 03, 2014

Class II

Product summary

Firm
GE OEC Medical Systems, Inc
Event
Event 69474
Status
Terminated
Classification
Class II
Quantity
5
Official record key
device-enforcement:Z-0194-2015

Official wording

Reason: 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.

Code information: Serial No: 3120PU3, 4851PU2, 5640PU8, 6052PU5, FIB0064

Distribution pattern: Worldwide Distribution.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.