medical Class II Updated 2025-04-09

GE Healthcare recalls GE Healthcare Centricity Centricity PACS-IW with Universal V

Recalled Product

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

Hazard / Issue

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.

Issued by

FDA

Distribution: Worldwide distribution.
Lot/Code Info: 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, UDI UDI Not Required, System ID GA001PACTRL01; Model/catalog/code # 2066908-136, Installed Product ID ZA2533-Centricity Universal Viewer-00116577, UDI UDI Not Required, 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.
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