Centricity Universal Viewer Software Versions 6.0 through 6.0 Sp10.4.1, a device that displays me...
FDA Device Recall #Z-1570-2026 — Class II — January 30, 2026
Recall Summary
| Recall Number | Z-1570-2026 |
| 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 | 797 units |
Product Description
Centricity Universal Viewer Software Versions 6.0 through 6.0 Sp10.4.1, a device that displays medical images (including mammograms) and data from various imaging sources, Model Numbers 2088026-406, 2100169-001, 2088026-985, 2088026-971, 2088026-614, 2088026-713, 2088026-994, 2100491-006, 2088026-723, 2088026-308, 2104867-044, 2100491-012, 2088026-962, 2088026-969, 2102676-001, 2088026-936, 2088026-960, K1220JWED, 2088026-806, 2088026-506, 2088026-026, 2088026-970, 2088026-943, 2088026-990, 2088026-940, 2088026-959, 2088026-967, 2088026-989, 2104867-045, 2088026-993, 2088026-306, 2102675-010, 2088026-948, 2088026-957, 2088026-973, 2088026-946, 2088026-715, 2088026-906
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
UDI Numbers: (01)00840682103800(10)6.0SP42094097001D (01)00840682103800(10)6.0SP7.12094097001H (01)00840682103800(10)60P102.2094097001H (01)00840682103800(10)60P901122094097001 (01)00840682103800(10)60P901122094097001 (01)00840682103800(10)6.0SP62094097001D (01)00840682103800(10)6.0SP72094097001D (01)00840682103800(10)6.0SP72094097001D (01)00840682103800(10)6.0SP72094097001D (01)00840682103800(10)60P10412094097001 (01)00840682103800(10)60P10412094097001 (01)00840682103800(10)6.0SP5.0.12094097001D (01)00840682103800(10)6.0SP7.12094097001E (01)00840682103800(10)6.0SP7.12094097001E (01)00840682103800(10)6.0SP3.12094097001D (01)00840682103800(10)6.0SP3.12094097001D (01)00840682103800(10)6.0SP3.12094097001D (01)00840682103800(10)6.0SP3.12094097001D (01)00840682103800(10)60SP5.0.42094097001D (01)00840682103800(10)60SP5.0.42094097001D (01)00840682103800(10)60SP5.0.42094097001D (01)00840682103800(10)60SP5.0.42094097001D (01)00840682103800(10)6.0SP5.0.1.12094097001D 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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-1571-2026 | Class II | Centricity Universal Viewer Software Versions 5... | 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.