Z-1571-2026Class II

Centricity Universal Viewer Software Versions 5.0 SP6 through UV 5.0 SP7.1, a device that displays medical...

Name: Z-1571-2026 Centricity Universal Viewer Software Versions 5.0 SP6 through UV 5.0 SP7.1, a device that displays medical...
Creator: GE Medical Systems, LLC
Published: 2026-01-30
License: https://open.fda.gov/license/

GE Healthcare / initiated 2026-01-30 / Open, Classified / root cause: software

FDA source

GE Medical Systems, LLC began a recall of Centricity Universal Viewer Software Versions 5.0 SP6 through UV 5.0 SP7.1, a device that displays medical images (including mammograms) and data from various... on 2026-01-30. FDA classified it as Class II and gives the reason as "There is a potential cybersecurity vulnerability affecting certain versions of Centricity Universal Viewer. User login credentials may be exposed on the local client workstation, which could allow an unauthorized...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as software.

Recall record

Recall number: Z-1571-2026
Classification: Class II
Status: Open, Classified
Initiated: 2026-01-30
Posted: 2026-03-16
Recalling firm: GE Healthcare
Product: Centricity Universal Viewer Software Versions 5.0 SP6 through UV 5.0 SP7.1, a device that displays medical images (including mammograms) and data from various imaging sources, Model Numbers 2088026-026, 2088026-115, 2088026-043, K2042VJED, 2088026-132, 2088026-003, 2088026-110, 2089629-003, 2066908-136, 2066908-150
Product code: LLZ System, Image Processing, Radiological
Reason for recall: There is a potential cybersecurity vulnerability affecting certain versions of Centricity Universal Viewer. User login credentials may be exposed on the local client workstation, which could allow an unauthorized individual to potentially impact system availability and/or manipulate data.
Root cause tag: software
FDA root cause: Software design
Action: An URGENT MEDICAL DEVICE CORRECTION notification letter dated 1/30/26 was sent to customers. Actions to be taken by Customer/User Pending corrections from GE HealthCare, you can continue using your device by following the instructions below: Ensure workstations have appropriate security controls per product manuals. Implement network account authentication by using Active Directory/LDAP services for user management. If network account authentication is not possible at your site, please contact GE HealthCare Service to request temporary steps to mitigate the issue. Ensure all potential users in your facility are informed of this safety notification. Please retain this document for your records. Please complete and return the attached acknowledgement form to [email protected]. GE HealthCare will correct all affected products at no cost to you. A GE HealthCare representative will contact you to arrange the correction. 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: 40 units
Distribution: Worldwide - US Nationwide distribution.
Product codes and lots: Product ID Numbers: 4446-2-Centricity Universal Viewer-00558643 100256-3-Centricity Universal Viewer-00558700 101044-1-Centricity Universal Viewer-00558694 13240-2-Centricity Universal Viewer-00558103 4441-1-Centricity Universal Viewer-00558677 4578-1-Centricity Universal Viewer-00558340 10831-2-Centricity Universal Viewer-00558682 656341-Centricity Universal Viewer-01431499 50567-Centricity Universal Viewer-02176369 2690973-Centricity Universal Viewer-01454622 EG1526-Centricity Universal Viewer-00158976 A91901-Centricity Universal Viewer-00044549 M3488569-Centricity Universal Viewer-00071707 25540620 - HC4105-Centricity Universal Viewer-00001393 416005-Centricity Universal Viewer-00260808 1868708X - 556162-Centricity Universal Viewer-00157857 HKOB01-Centricity Universal Viewer-01282268 BMH-Centricity Universal Viewer-01820534 JIPMER-Centricity Universal Viewer-01820555 4347967-Centricity Universal Viewer-01474540 651342-Centricity Universal Viewer-01365218 651342-Centricity Universal Viewer-01365213 A3431341-Centricity Universal Viewer-00545677 473265-Centricity Universal Viewer-01442014 JP-131575-Centricity Universal Viewer-01275307 442900-Centricity Universal Viewer-01460668 577127-Centricity Universal Viewer-01444349 349551-Centricity Universal Viewer-02350518 PL3277-Centricity Universal Viewer-00038831 RU3866-Centricity Universal Viewer-01445731 RU8945-Centricity Universal Viewer-01445740 RU2580-Centricity Universal Viewer-01445743 1354732-Centricity Universal Viewer-01273292 RU3453-Centricity Universal Viewer-01273249 SA2160-Centricity Universal Viewer-00111827 SA1208-Centricity Universal Viewer-00066587 882983-Centricity Universal Viewer-02277629 ZA2533-Centricity Universal Viewer-00116577

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1571-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1569-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-03-25	2026-03-16
Z-1570-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-03-25	2026-03-16
Z-1571-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-03-25	2026-03-16

Product code LLZ

K123174Class IICentricity Pacs-Iw with Universal ViewerGE Healthcare / cleared 2012-11-16

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)