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Recall Observatory FDA recall evidence

Device product

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

Z-0195-2019

August 30, 2018

Class II

Product summary

Firm
GE Healthcare, LLC
Event
Event 81297
Status
Terminated
Classification
Class II
Quantity
1
Official record key
device-enforcement:Z-0195-2019

Official wording

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

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

Distribution pattern: NY

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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