FDAClass IIFebruary 1, 2017

OEC 9800. MDL Numbers: D222250 recall

OEC 9800. MDL Numbers: D222250, D141598

Why was OEC 9800. MDL Numbers: D222250 recalled?

GE Healthcare Surgery announces a voluntary field action for the OEC 9800 and OEC 9900 Elite due to additional supplementation to the user documentation to include areas for enhanced planned maintenance and component replacement frequencies.

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?

Manufactured from Feb 1998 to present

Product
OEC 9800. MDL Numbers: D222250, D141598
Recalling firm
GE OEC Medical Systems, Inc
Quantity
26,256 total
Distribution
Worldwide including govt/VA/military and foreign consignees.
Recall date
February 1, 2017
Classification
Class II
Status
Terminated
Agency
FDA (device)
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