Centricity Universal Viewer Software Versions 5.0 SP6 through UV 5.0 SP7.1, a device that display...
FDA Device Recall #Z-1571-2026 — Class II — January 30, 2026
Recall Summary
| Recall Number | Z-1571-2026 |
| Classification | Class II — Moderate risk |
| Date Initiated | January 30, 2026 |
| Status | Ongoing |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | GE Medical Systems, LLC |
| Location | Waukesha, WI |
| Product Type | Devices |
| Quantity | 40 units |
Product Description
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
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.
Distribution Pattern
Worldwide - US Nationwide distribution.
Lot / Code Information
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
Other Recalls from GE Medical Systems, LLC
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-1590-2026 | Class II | Imactis CT-Navigation System, stereotaxic acces... | Feb 3, 2026 |
| Z-1570-2026 | Class II | Centricity Universal Viewer Software Versions 6... | Jan 30, 2026 |
| Z-1569-2026 | Class II | Centricity Universal Viewer Software Versions 7... | Jan 30, 2026 |
| Z-0875-2026 | Class II | Senographe Pristina, Pristina Serena, and Prist... | Oct 24, 2025 |
| Z-0157-2026 | Class II | LOGIQ P9 R4.5 ultrasound system with system sof... | Sep 18, 2025 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.