RecallRadar

FDA Device recall Z-0195-2019

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

On 2018-10-24 the FDA classified a Class II recall of Centricity Universal Viewer with Cross Enterprise Display This impacts product versions 6.0 SP1 and higher by Ge Healthcare, citing remote comparison studies displayed may be associated with the wrong patient, without a caution icon present.

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-0195-2019
ClassificationClass II
Statusterminated
Initiated2018-08-30
Published2018-10-24
Last updated2026-09-13 11:54 UTC
CompanyGe Healthcare
DistributionNY

Product

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

Reason

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

Identifiers

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

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0195-2019%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.