CLASS II Device recall · Reported 24 Oct 2018 · FDA Enforcement Report

Centricity Universal Viewer recalled by GE Healthcare

GE Healthcare is recalling Centricity Universal Viewer with Cross Enterprise Display This impacts product versions, distributed in New York. The recall was initiated on 30 Aug 2018 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesSYSTEM ID: 315470CPUWPV UDI #: 8406821038 00DE #: 2090255-001

Quantity recalled1

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0195-2019
FDA event ID: 81297
Recalling firm: GE Healthcare, Waukesha, WI
Classification: Class II
Status: Terminated
Recall initiated: 30 Aug 2018
FDA classified: 18 Oct 2018
Reported: 24 Oct 2018
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

30 Aug 2018	Recall initiated by company
18 Oct 2018	Classified by FDA	+49 days
24 Oct 2018	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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

Product as listed by the FDA

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

Where it was distributed

New York

Questions about this recall

Why was it recalled?

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

Which lots are affected?

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

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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