FDAClass IIOctober 24, 2018

Centricity Universal Viewer with Cross Enterprise recall

Centricity Universal Viewer with Cross Enterprise Display This impacts product versions 6.0 SP1 and higher.

Why was Centricity Universal Viewer with Cross Enterprise recalled?

Remote comparison studies displayed may be associated with the wrong patient, without a caution icon present.

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?

SYSTEM ID: 315470CPUWPV UDI #: 8406821038 00DE #: 2090255-001

Product
Centricity Universal Viewer with Cross Enterprise Display This impacts product versions 6.0 SP1 and higher.
Recalling firm
GE Healthcare, LLC
Quantity
1
Distribution
NY
Recall date
October 24, 2018
Classification
Class II
Status
Terminated
Agency
FDA (device)
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