Z-1466-2022Class II

Centricity PACS Software Version 7.0 SP0.0.4.7

Name: Z-1466-2022 Centricity PACS Software Version 7.0 SP0.0.4.7
Creator: GE Healthcare, LLC
Published: 2022-06-14
License: https://open.fda.gov/license/

GE Healthcare / initiated 2022-06-14 / Terminated / root cause: software

FDA source

GE Healthcare, LLC began a recall of Centricity PACS Software Version 7.0 SP0.0.4.7 on 2022-06-14. FDA classified it as Class II and gives the reason as "The Event Notification Manager (ENM) functionality for certain products does not process notifications for study modifications performed on post verified exams". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-1466-2022
Classification: Class II
Status: Terminated
Initiated: 2022-06-14
Posted: 2022-07-25
Terminated: 2024-01-16
Recalling firm: GE Healthcare
Product: Centricity PACS Software Version 7.0 SP0.0.4.7
Product code: LLZ System, Image Processing, Radiological
Reason for recall: The Event Notification Manager (ENM) functionality for certain products does not process notifications for study modifications performed on post verified exams.
Root cause tag: software
FDA root cause: Software design
Action: An Urgent Medical Device Correction letter was sent to customers beginning June 14, 2022. The letter informs the customer of the issue and provides safety instructions for continued use of the device. GE Healthcare will correct all affected devices via a software update. In the U.S., this letter will be sent by a traceable means. This letter will be sent to the following titles within the affected accounts: Director/Manager of Radiology, Director/Manager of Cardiology, Risk Manager/Hospital Administrator, Head of Radiology Department, Head of Cardiology Department, PACS Administrator, Director of IT Department, Head of Biomedical Engineering, Head of Imaging Informatics.
Quantity in commerce: 47 installations
Distribution: Worldwide distribution - US Nationwide distribution in the states of CO, NV, OH, PA, WA and the countries of Brazil, Canada, China, France, Germany, Israel, Italy, Japan, Oman, Spain, Switzerland, and United Kingdom.
Product codes and lots: Model: 5831882-012, Software Version 7.0 SP0.0.4.7 GTIN: 00840682145572

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1466-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1466-2022	Class II	Terminated	Voluntary: Firm initiated	2022-08-03	2022-07-25

Product code LLZ

K110875Class IICentricity PacsGE Healthcare / cleared 2011-05-05

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)