FDA Medical devices recall ·
Centricity Universal Viewer Software Versions 7.0 through 7.0 Sp2.0.1… recall
- Recall number
- Z-1569-2026
- Date
- (initiated January 30, 2026)
- Company / brand
- GE Medical Systems, LLC
3000 N Grandview Blvd, Waukesha, WI, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 1568 units
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
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
Why was it recalled?
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.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
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 (01)00840682145794(10)70P15825832001 (01)00840682145794(10)70P15825832001 (01)00840682145794(10)70P15825832001 (01)00840682145794(10)70P15825832001 (01)00840682145794(10)70P15825832001 (01)00840682145794(10)70P15825832001 (01)00840682145794(10)70P15825832001 (01)00840682145794(10)70P15825832001 (01)00840682145
Distribution
Worldwide - US Nationwide distribution.
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-1569-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.