Recall Z-0195-2019— GE Healthcare, LLC

Name: FDA recall Z-0195-2019
Creator: U.S. Food and Drug Administration
Published: 2018-08-30

Class II · Terminated

Class II FDA medical device recall by GE Healthcare, LLC, initiated 2018-08-30, terminated 2022-08-31. It names one FDA 510(k) clearance: K150420. 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..

Recalling firm: GE Healthcare, LLC
Classification: Class II
Status: Terminated
Initiated: 2018-08-30
Terminated: 2022-08-31
Firm location: Waukesha, WI, United States

510(k) clearances named in this recall

1 on FDA's record

K150420 — Centricity Universal ViewerGE Healthcare·cleared 2015-05-26

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.