The Recall Desk
HighFDA (Devices)·Z-1487-2025·Announced 2025-04-09

GE Healthcare medical imaging systems security vulnerability could allow data access

GE Healthcare Centricity imaging systems contain a security vulnerability where service login credentials can be identified. This could allow unauthorized access and potential patient data manipulation.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is an FDA Class II recall for a medical device with potential for unauthorized system access and patient data manipulation. No reported incidents, injuries, or illnesses are documented. Per the severity rubric, risk-of-harm products where injury has not yet been reported score as High (3).

Plain-English summary

GE Healthcare has identified a security vulnerability in Centricity Universal Viewer, Centricity PACS-IW, Centricity Radiology RA600, and Centricity Cardiology CA1000 systems. The vulnerability allows service login credentials to be identified.

If a malicious actor obtains these credentials, they could access the affected systems and potentially manipulate patient data. This represents a risk to patient safety and data integrity in healthcare facilities using these systems.

The recall affects four specific system configurations with worldwide distribution. Affected healthcare facilities and organizations using these systems should contact GE Healthcare for information about patches, updates, or other mitigation strategies.

Facilities should consult with GE Healthcare and review the FDA recall notice for guidance on addressing this vulnerability and protecting patient data.

The recalled product

Product
GE Healthcare Centricity Centricity PACS-IW with Universal Viewer, Model Numbers: 1) 2049587-015; 2) 2066908-086; 3) 2066908-136; 4) 2104867-045.
Manufacturer
GE Healthcare
Category
Medical Device — Diagnostic Imaging Systems
Hazard
  • credential-exposure
  • unauthorized-access
  • patient-data-at-risk

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (14)

  • Model/catalog/code # 2049587-015
  • Installed Product ID 100707-1-Centricity Universal Viewer-00558649
  • UDI UDI Not Required
  • System ID PACS-IW-126
  • Model/catalog/code # 2066908-086
  • Installed Product ID 9842-4-Centricity Universal Viewer-19386293
  • System ID GA001PACTRL01
  • Model/catalog/code # 2066908-136
  • Installed Product ID ZA2533-Centricity Universal Viewer-00116577
  • System ID ZA2533PAC1
  • Model/catalog/code # 2104867-045
  • Installed Product ID X9003062 - HC3062-Centricity Universal Viewer-01462397
  • UDI (01)00840682103800(10)6.0SP50412094097001D
  • System ID HC3062UV01.

Distribution

Distribution scope not specified by the agency.

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