Recall Z-0721-2023— GE Medical Systems, LLC

Name: FDA recall Z-0721-2023
Creator: U.S. Food and Drug Administration
Published: 2022-10-28

Class II · Ongoing

Class II FDA medical device recall by GE Medical Systems, LLC, initiated 2022-10-28. It names one FDA 510(k) clearance: K123174. Product: Centricity PACS-IW with Universal Viewer version 5.0. Used to display medical images (Including mammograms) and data from various imaging sources.. Reason: There is the potential that after installation of the IAS tool, some studies can remain hidden without user notification. Access to those hidden studies requires GE Healthcare assistance, which can result in a delay in reading the study..

Recalling firm: GE Medical Systems, LLC
Classification: Class II
Status: Ongoing
Initiated: 2022-10-28
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. Used to display medical images (Including mammograms) and data from various imaging sources.

Reason for recall

There is the potential that after installation of the IAS tool, some studies can remain hidden without user notification. Access to those hidden studies requires GE Healthcare assistance, which can result in a delay in reading the study.

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