Centricity Universal Viewer Software Versions 6.0 through 6.0 Sp10.4.1, a device that displays medical images (including
Summary
The FDA issued a Class II for Centricity Universal Viewer Software Versions 6.0 through 6.0 Sp10.4.1, a device by GE Medical Systems, LLC. Reason: There is a potential cybersecurity vulnerability affecting certain versions of Centricity Universal Viewer. User login credentials may be exposed on t.
Details
Source
Device Recall
External ID
Z-1570-2026
Action Date
2026-03-25
Status
Ongoing
Category
device
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
Lot/Code Info: 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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Quantity Affected: 797 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.
Distribution
Worldwide - US Nationwide distribution.
Type: Voluntary: Firm initiated
Recall Initiated: 2026-01-30
Company
Waukesha, WI
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 156 device recalls issued in the same week, part of 403 device-related FDA actions this month.
GE Medical Systems, LLC has 138 FDA actions in our database, including 121 recalls and 17 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (GE Medical Systems, LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does GE Medical Systems, LLC have FDA actions?
GE Medical Systems, LLC has 138 FDA actions in our database, including 121 recalls and 17 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1570-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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