FDA-Device2026-03-25Class II

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, 2088

GE Medical Systems, LLC

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.

Sold states

Worldwide - US Nationwide distribution.

Affected count

797 units

Manufactured in

3000 N Grandview Blvd, N/A, Waukesha, WI, United States

Products

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1570-2026

Original summary

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 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. 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 (01)00840682103800(10)60SP5.0.42094097001D (01)00840682103800(10)60SP5.0.42094097001D (01)00840682103800(10)6.0SP5.0.12094097001D (01)00840682103800(10)6.0SP5.0.1.12094097001D (01)00840682103800(10)60P901122094097001 (01)00840682103800(10)60P901122094097001 (01)00840682103800(10)60P901122094097001 (01)00840682103800(10)60P901122094097001 (01)00840682103800(10)60P901122094097001 (01)00840682103800(10)60P901122094097001 (01)00840682103800(10)60P901122094097001 (01)00840682103800(10)60P901122094097001 (01)00840682103800(10)60SP5.0.42094097001D (01)00840682103800(10)60SP5.0.42094097001D (01)00840682103800(10)60SP5.0.42094097001D (01)00840682103800(10)60P901122094097001 (01)00840682103800(10)60P901122094097001 (01)00840682103800(10)60P901122094097001 (01)00840682103800(10)60P901122094097001 (01)00840682103800(10)6.0SP5.0.12094097001D (01)00840682103800(10)60P901122094097001 (01)00840682103800(10)60P901122094097001 (01)00840682103800(10)60P901122094097001 (01)00840682103800(10)6.0SP7.12094097001E (01)00840682103800(10)6.0SP7.12094097001E (01)00840682103800(10)6.0SP7.12094097001E (01)00840682103800(10)60SP5.0.42094097001D (01)00840682103800(10)60P901122094097001 (01)00840682103800(10)6.0SP5.0.12094097001D (01)00840682103800(10)60P901122094097001 (01)00840682103800(10)6.0SP7.12094097001E (01)00840682103800(10)6.0SP7.12094097001E (01)00840682103800(10)60P901122094097001 (01)00840682103800(10)60P901122094097001 (01)00840682103800(10)60P901122094097001 (01)00840682103800(10)60SP90182094097001H (01)00840682103800(10)60P901122094097001 (01)00840682103800(10)60P901122094097001 (01)00840682103800(10)60P901122094097001 (01)00840682103800(10)60P901122094097001 (01)00840682103800(10)60P901122094097001 (01)00840682103800(10)60SP5.0.42094097001D (01)00840682103800(10)60SP5.0.42094097001D (01)00840682103800(10)60SP5.0.42094097001D (01)00840682103800(10)6.0SP42094097001D (01)00840682103800(10)60SP5.0.42094097001D (01)00840682103800(10)6.0SP7.12094097001E (01)00840682103800(10)6.0SP3.12094097001D (01)00840682103800(10)6.0SP7.12094097001H (01)00840682103800(10)6.0SP7.12094097001H (01)00840682103800(10)60SP5.0.42094097001D (01)00840682103800(10)60SP5.0.42094097001D (01)00840682103800(10)60SP5.0.42094097001D (01)00840682103800(10)6.0SP7.12094097001E (01)00840682103800(10)60SP5.0.42094097001D (01)00840682103800(10)60P90111.2094097001H (01)00840682103800(10)60P90111.2094097001H (01)00840682103800(10)60P90111.2094097001H (01)00840682103800(10)6.0SP3.12094097001D (01)00840682103800(10)6.0SP7.12094097001E (01)00840682103800(10)6.0SP7.12094097001E (01)00840682103800(10)6.0SP7.12094097001E (01)00840682103800(10)6.0SP7.12094097001E (01)00840682103800(10)60SP5.0.42094097001D (01)00840682103800(10)60SP5.0.42094097001D (01)00840682103800(10)6.0SP5.0.32094097001D (01)00840682103800(10)60P90111.2094097001H (01)00840682103800(10)60P90111.2094097001H (01)00840682103800(10)60P90111.2094097001H (01)00840682103800(10)6.0SP5.0.32094097001D (01)00840682103800(10)6.0SP4.0.22094097001D (01)00840682103800(10)6.0SP7.12094097001E (01)00840682103800(10)6.

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