Recall Z-1566-2022— GE Healthcare, LLC

Name: FDA recall Z-1566-2022
Creator: U.S. Food and Drug Administration
Published: 2022-07-15

Class II · Ongoing

Class II FDA medical device recall by GE Healthcare, LLC, initiated 2022-07-15. It names 3 FDA 510(k) clearances: K211312, K182419, K150420. Product: (1) GE Centricity Universal Viewer 6.0, Model 2088026-9XX; (2) GE Centricity Universal Viewer 7.0, Model 5826659-0XX; (3) GE Universal Viewer 8.0, Model 5865740-00x.. Reason: Inaccurate Distance and Area measurements with use of Global Stack viewport..

Recalling firm: GE Healthcare, LLC
Classification: Class II
Status: Ongoing
Initiated: 2022-07-15
Firm location: Waukesha, WI, United States

510(k) clearances named in this recall

3 on FDA's record

K211312 — Universal ViewerGE Healthcare·cleared 2021-05-21
K182419 — Centricity Universal ViewerGE Healthcare·cleared 2018-12-14
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

(1) GE Centricity Universal Viewer 6.0, Model 2088026-9XX; (2) GE Centricity Universal Viewer 7.0, Model 5826659-0XX; (3) GE Universal Viewer 8.0, Model 5865740-00x.

Reason for recall

Inaccurate Distance and Area measurements with use of Global Stack viewport.

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