Z-0012-2022Class II

Centricity Universal Viewer 7.0, Model 5829628-0XX. Radiological image processing system

Name: Z-0012-2022 Centricity Universal Viewer 7.0, Model 5829628-0XX. Radiological image processing system
Creator: GE Healthcare, LLC
Published: 2021-08-12
License: https://open.fda.gov/license/

GE Healthcare / initiated 2021-08-12 / Terminated / root cause: software

FDA source

GE Healthcare, LLC began a recall of Centricity Universal Viewer 7.0, Model 5829628-0XX. Radiological image processing system on 2021-08-12. FDA classified it as Class II and gives the reason as "A software anomaly exists in the Centricity Universal Viewer study management feature in which study changes are not propagated to either the Centricity Enterprise Archive (EA) or another Vendor Neutral Archive (VNA)". 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-0012-2022
Classification: Class II
Status: Terminated
Initiated: 2021-08-12
Posted: 2021-10-02
Terminated: 2024-08-22
Recalling firm: GE Healthcare
Product: Centricity Universal Viewer 7.0, Model 5829628-0XX. Radiological image processing system
Product code: LLZ System, Image Processing, Radiological
Reason for recall: A software anomaly exists in the Centricity Universal Viewer study management feature in which study changes are not propagated to either the Centricity Enterprise Archive (EA) or another Vendor Neutral Archive (VNA).
Root cause tag: software
FDA root cause: Other
Action: This issue will be resolved by sending an Urgent Medical Device Correction letter to customers with affected software versions on August 13, 2021. This letter informs customers of the issues and provides safety instructions. GE Healthcare will correct the issue through a product change. If you have any questions or concerns regarding this notification, please contact GE Healthcare Service at 1-800-437-1171 or your local Service Representative.
Quantity in commerce: 49
Distribution: AR, IL, ME, MS, NE, NJ, NY, and TN Belgium, Canada, Costa Rica, France, Germany, India, Japan, Korea, Kuwait, Saudi Arabia, Singapore, Switzerland, Switzerland, Turkey and United Kingdom
Product codes and lots: Centricity Universal Viewer, Software Versions 7.0 SP0.0.4.5 and 7.0 SP0.0.5 GTIN 00840682145794

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0012-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0012-2022	Class II	Terminated	Voluntary: Firm initiated	2021-10-13	2021-10-01

Product code LLZ

K182419Class IICentricity Universal ViewerGE Healthcare / cleared 2018-12-14

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)