Recall Z-0329-2022— GE Healthcare, LLC

Name: FDA recall Z-0329-2022
Creator: U.S. Food and Drug Administration
Published: 2021-10-15

Class II · Ongoing

Class II FDA medical device recall by GE Healthcare, LLC, initiated 2021-10-15. It names one FDA 510(k) clearance: K131977. Product: GE Centricity Universal Viewer Zero Footprint Client. Reason: There is a potential to display incomplete patient imaging study..

Recalling firm: GE Healthcare, LLC
Classification: Class II
Status: Ongoing
Initiated: 2021-10-15
Firm location: Waukesha, WI, United States

510(k) clearances named in this recall

1 on FDA's record

K131977 — CENTRICITY UNIVERSAL VIEWER ZERO FOOTPRINT CLIENTGE Healthcare·cleared 2013-09-17

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

GE Centricity Universal Viewer Zero Footprint Client

Reason for recall

There is a potential to display incomplete patient imaging study.

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