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Recall Observatory FDA recall evidence

Device product

OEC¿ UroView 2800. The UroView 2800 is designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical. and interventional procedures

Z-0192-2015

October 03, 2014

Class II

Product summary

Firm
GE OEC Medical Systems, Inc
Event
Event 69474
Status
Terminated
Classification
Class II
Quantity
2
Official record key
device-enforcement:Z-0192-2015

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: P4-0490-R and P6-0705-L

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.