Company: GE Healthcare, LLC
Date of Enforcement Report: 10/24/2018
Class II:

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

Recall Number: Z-0195-2019

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

RECALLING FIRM/MANUFACTURER
GE Healthcare, LLC, Waukesha, WI on 8/30/2018. Voluntary: Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
1

DISTRIBUTION
NY