Recall Z-0374-2019— GE Healthcare, LLC

Name: FDA recall Z-0374-2019
Creator: U.S. Food and Drug Administration
Published: 2018-10-11

Class II · Terminated

Class II FDA medical device recall by GE Healthcare, LLC, initiated 2018-10-11, terminated 2023-03-20. It names one FDA 510(k) clearance: K123174. Product: Centricity PACS-IW with Universal Viewer version 5.0.x with PACS-IW foundation displays medical images (including mammograms) and data from various imaging sources.. Reason: Synchronization failure.

Recalling firm: GE Healthcare, LLC
Classification: Class II
Status: Terminated
Initiated: 2018-10-11
Terminated: 2023-03-20
Firm location: Waukesha, WI, United States

510(k) clearances named in this recall

1 on FDA's record

K123174 — CENTRICITY PACS-IW WITH UNIVERSAL VIEWERGE Healthcare·cleared 2012-11-16

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 PACS-IW with Universal Viewer version 5.0.x with PACS-IW foundation displays medical images (including mammograms) and data from various imaging sources.

Reason for recall

Synchronization failure

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