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Priority review Enforcement Amended Final

GE Centricity Universal Viewer Software Cybersecurity Vulnerability Recall

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Summary

FDA issued a Class II recall for GE Medical Systems Centricity Universal Viewer Software Versions 7.0 through 7.0 Sp2.0.1 due to a cybersecurity vulnerability. User login credentials may be exposed on local client workstations, potentially allowing unauthorized access that could impact system availability or enable data manipulation. The affected product displays medical images including mammograms from various imaging sources.

What changed

FDA issued a Class II medical device recall for GE Centricity Universal Viewer software due to a cybersecurity vulnerability affecting versions 7.0 through 7.0 Sp2.0.1. The vulnerability could expose user login credentials on local client workstations, potentially allowing unauthorized individuals to impact system availability or manipulate data. The recall affects the Universal Viewer which displays medical images including mammograms from various imaging sources.

Healthcare facilities using this software should verify whether their installations are affected, as the cybersecurity flaw could compromise patient data confidentiality and system integrity. GE Medical Systems LLC is conducting this recall on an ongoing basis with worldwide distribution including US nationwide coverage.

What to do next

  1. Identify affected Centricity Universal Viewer versions 7.0 through 7.0 Sp2.0.1 in your facility
  2. Contact GE Medical Systems for remediation guidance
  3. Assess whether login credentials may have been compromised on affected workstations

Archived snapshot

Apr 11, 2026

GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.

GE Medical Systems, LLC

Device Recalls (Class II)

← All Device Recalls (Class II) Class II Z-1569-2026 · 20260325 · Ongoing

Product

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,...

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.

Source: openFDA Enforcement API

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Last updated

Classification

Agency
FDA
Filed
March 25th, 2026
Instrument
Enforcement
Legal weight
Binding
Stage
Final
Change scope
Substantive
Document ID
Z-1569-2026

Who this affects

Applies to
Medical device makers Healthcare providers
Industry sector
3345 Medical Device Manufacturing
Activity scope
Medical device recall Cybersecurity remediation Medical imaging software
Threshold
Centricity Universal Viewer Software Versions 7.0 through 7.0 Sp2.0.1; Model Numbers 5826659-027
Geographic scope
United States US

Taxonomy

Primary area
Medical Devices
Operational domain
Clinical Operations
Compliance frameworks
NIST CSF
Topics
Cybersecurity Healthcare

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