Recall Z-1466-2022— GE Healthcare, LLC

Name: FDA recall Z-1466-2022
Creator: U.S. Food and Drug Administration
Published: 2022-06-14

Class II · Terminated

Class II FDA medical device recall by GE Healthcare, LLC, initiated 2022-06-14, terminated 2024-01-16. It names one FDA 510(k) clearance: K110875. Product: Centricity PACS Software Version 7.0 SP0.0.4.7. Reason: The Event Notification Manager (ENM) functionality for certain products does not process notifications for study modifications performed on post verified exams..

Recalling firm: GE Healthcare, LLC
Classification: Class II
Status: Terminated
Initiated: 2022-06-14
Terminated: 2024-01-16
Firm location: Waukesha, WI, United States

510(k) clearances named in this recall

1 on FDA's record

K110875 — CENTRICITY PACSGE Healthcare·cleared 2011-05-05

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 Software Version 7.0 SP0.0.4.7

Reason for recall

The Event Notification Manager (ENM) functionality for certain products does not process notifications for study modifications performed on post verified exams.

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