FDAClass IINovember 19, 2014

FlexiView 8800 Digital Mobile Imaging System. The recall

FlexiView 8800 Digital Mobile Imaging System. The FlexiView 8800 Digital Mobile Imaging System is designed to provide fluoroscopic and spot film…

Why was FlexiView 8800 Digital Mobile Imaging System. The 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.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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

Product
FlexiView 8800 Digital Mobile Imaging System. The FlexiView 8800 Digital Mobile Imaging System is designed to provide fluoroscopic and spot film…
Recalling firm
GE OEC Medical Systems, Inc
Quantity
5
Distribution
Worldwide Distribution.
Recall date
November 19, 2014
Classification
Class II
Status
Terminated
Agency
FDA (device)
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