Recall Z-1569-2026
GE Medical Systems, LLC · initiated January 30, 2026
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
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, 5826659-014, 5826659-016, 5826659-013
Codes / lots: UDI Numbers: (01)00840682145794(10)70P004105825832001 (01)00840682145794(10)70P1015825832001 (01)00840682145794(10)70P1025825832001 (01)00840682145794(10)70P004105825832001 (01)00840682145794(10)70P1015825832001 (01)00840682145794(10)70P1015825832001 (01)00840682145794(10)70P1015825832001 (01)00840682145794(10)70P1015825832001 (01)00840682145794(10)70P1025825832001 (01)00840682145794(10)70P004105825832001 (01)00840682145794(10)70P1015825832001 (01)00840682145794(10)70P1025825832001 (01)00840682145794(10)70P1025825832001 (01)00840682145794(10)70P1025825832001 (01)00840682145794(10)70P1025825832001 (01)00840682145794(10)70P1035825832001 (01)00840682145794(10)70P1035825832001 (01)00840682145794(10)70P004105825832001 (01)00840682145794(10)70P004105825832001 (01)00840682145794(10)70P004105825832001 (01)00840682145794(10)70P004105825832001 (01)00840682145794(10)70P1035825832001 (01)00840682145794(10)70P004105825832001 (01)00840682145794(10)70P1035825832001 (01)00840682145794(10)70P1035825832001 (01)00840682145794(10)70P15825832001 (01)00840682145794(10)70P15825832001 (01)00840682145794(10)70P15825832001 (01)00840682145794(10)70P15825832001 (01)00840682145794(10)70P15825832001…
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.
FDA-determined cause: Software design
Action taken
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 recall.85491@gehealthcare.com. 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.
Details
- Recall number
- Z-1569-2026
- Initiated
- January 30, 2026
- Posted by FDA
- March 16, 2026
- Product code
- LLZ – System, Image Processing, Radiological
- Quantity
- 1568 units
- Distribution
- Worldwide - US Nationwide distribution.
- Recalling firm
- GE Medical Systems, LLC, Waukesha, WI
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1570-2026 Class II | Centricity Universal Viewer Software Versions 6.0 through 6.0 Sp10.4.1, a device that…There is a potential cybersecurity vulnerability affecting certain versions of Centricity Universal Viewer.… | 01/30/2026Open, Classified |
| Z-1571-2026 Class II | Centricity Universal Viewer Software Versions 5.0 SP6 through UV 5.0 SP7.1, a device…There is a potential cybersecurity vulnerability affecting certain versions of Centricity Universal Viewer.… | 01/30/2026Open, Classified |