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