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FDA (Device enforcement)Recalled 2025-02-19class ii

GE Healthcare: GE Healthcare Centricity Universal Viewer (UV), Model Numbers: 1) 2066908-077; 2) 2066908-136; 3) 2066908-150; 4) 2088026-003; 5) 2088026-026; 6) 2088026-032; 7) 2088026-043; 8) 2088026

Hazard

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.

Details from the source

Reason for recall: 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. Distribution: Worldwide distribution. Quantity: 2653 units Lot/code info: Model/Catalog/code # 2066908-077, Installed Product ID 000346895-Centricity Universal Viewer-01804910, UDI UDI Not Required, System ID HCIT1584981UV; Model/Catalog/code # 2066908-077, Installed Product ID 3444574-Centricity Universal Viewer-19417270, UDI UDI Not Required, System ID RSMKG-SERPONG02; Model/Catalog/code # 2066908-136, Installed Product ID 280801-Centricity Universal Viewer-19737221, UDI UDI Not Required, System ID HCIT1545332UVCTRL; Model/Catalog/code # 2066908-136, Installed Product ID 651342-Centricity Universal Viewer-01365218, UDI UDI Not Required, System ID RSPBINTARO3; Model/Catalog/code # 2066908-136, Installed Product ID 265719-Centricity Universal Viewer-01455055, UDI UDI Not Required, System ID HCIT4376494UV; Model/Catalog/code # 2066908-150, Installed Product ID KE2701-DF UV 50K BASE-00394965, UDI UDI Not Required, System ID KE2701UV01; Model/Catalog/code # 2066908-150, Installed Product ID KE0301-Centricity Universal Viewer-00116859, UDI UDI Not Required, System ID KE0301UV01; Model/Catalog/code # 2066908-150, Installed Product ID KE4102-Centricity Universal Viewer-01402658, UDI UDI Not Required, System ID KE4102UW02; Model/Catalog/code # 2066908-150, Installed Product ID KE1701-Centricity Universal Viewer-01292401, UDI UDI Not Required, System ID KE1701UV01; Model/Catalog/code # 2066908-150, Installed Product ID KE3502-Centricity Universal Viewer-01400662, UDI UDI Not Required, System ID KE3502UW02; Model/Catalog/code # 2066908-150, Installed Produc

UPC codes

00840682103800

Source

Official record: FDA (Device enforcement)

Republished from the official source above; details can change — the source record controls.

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