FDA DevicesClass II
Centricity Universal Viewer Software Versions 7.0 through 7.0 Sp2.0.1, a device ...
Published: March 25, 2026Recall ID: Z-1569-2026Category: devicesCountry: US
Reason for Recall / Hazard
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.
Product Description & Identification
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
Additional Source Details
| Field | Value |
|---|---|
| City | Waukesha |
| State | WI |
| Event id | 98428 |
| Address 1 | 3000 N Grandview Blvd |
| Address 2 | N/A |
| Code info | 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)70P1035825832... [TRUNCATED] |
| Postal code | 53188-1615 |
| Report date | 20260325 |
| Product type | Devices |
| Product quantity | 1568 units |
| 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. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260130 |
| Initial firm notification | Letter |
| Center classification date | 20260316 |
Overview
- Recalling FirmGE Medical Systems, LLC
- StatusOngoing
- Risk LevelClass II
- DistributionWorldwide - US Nationwide distribution.