Recall Z-1781-2019— GE Healthcare, LLC

Name: FDA recall Z-1781-2019
Creator: U.S. Food and Drug Administration
Published: 2019-05-22

Class II · Terminated

Class II FDA medical device recall by GE Healthcare, LLC, initiated 2019-05-22, terminated 2024-09-20. It names one FDA 510(k) clearance: K082318. Product: GE Centricity PACS-IW versions 3.6.0 through 3.7.3.9 SP1, SP2, SP3 and 3.7.3 SPa10, Model Numbers: a) 2052831-00x b) 2050578-0xx c) 2090228-002 d) 2052782-00x. Reason: There is a potential that one or more image series (i.e., all images within an image set) may be missing from an exam without a warning displayed in the viewer..

Recalling firm: GE Healthcare, LLC
Classification: Class II
Status: Terminated
Initiated: 2019-05-22
Terminated: 2024-09-20
Firm location: Waukesha, WI, United States

510(k) clearances named in this recall

1 on FDA's record

K082318 — CENTRICITY PACS IWGe Healthcare Dynamic Imaging Solutions·cleared 2008-08-25

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 PACS-IW versions 3.6.0 through 3.7.3.9 SP1, SP2, SP3 and 3.7.3 SPa10, Model Numbers: a) 2052831-00x b) 2050578-0xx c) 2090228-002 d) 2052782-00x

Reason for recall

There is a potential that one or more image series (i.e., all images within an image set) may be missing from an exam without a warning displayed in the viewer.

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