Medical device recalls Moderate risk

GE Healthcare recalls GE Healthcare Centricity Centricity PACS-IW with Universal Viewer, Model Numbers: 1) 2049587-015; 2) 2066908-086; 3) 20…

Recall date
February 19, 2025
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1487-2025
FDA classification
Class II
Brand / firm
GE Healthcare
Sold / distributed
Worldwide distribution.

Why it was recalled

There is a potential security vulnerability in Centricity Universal Viewer (UV), Centricity PACS-IW (PACS-IW), Centricity Radiology RA600 (RA600), & Centricity Cardiology CA1000 (CA1000) where the service login credentials are able to be identified which could allow a malicious actor with these credentials to access the system and potentially manipulate patient data.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

GE Healthcare Centricity Centricity PACS-IW with Universal Viewer, Model Numbers: 1) 2049587-015; 2) 2066908-086; 3) 2066908-136; 4) 2104867-045.

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