Recall Z-1569-2026 ยท LLZ System, Image Processing, Radiological
GE Medical Systems, LLC
Centricity Universal Viewer Software Versions 7.0 through 7.0 Sp2.0.1, a device that displays medical images (including mammograms) and data from various imaging sources, Model Numbers 5826659-027, 5826659-029, 5826659-032, 5826659-033, 5826659-028, 5826659-034, 5826659-030, 5826659-019, 5826659-022, 5826659-026, 5826659-023, 5826659-031, 5826659-025, 5826659-002, 5826659-021, 5826659-037, 5826659
| Date | Mar 16, 2026 (initiated Jan 30, 2026) |
| Status | Open, Classified |
| Reason | 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 | 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 i |
| Quantity | 1568 units |
| Distribution | Worldwide - US Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K182419 | Centricity Universal Viewer GE Healthcare, Dec 14, 2018 |