GE Healthcare: GE Healthcare Centricity Radiology RA600 (RA600), Model Numbers: 1) 2022296-001; 2) 2033901-001; 3) 2038437-001; 4) 2038437-011; 5) 2038437-012; 6) 2038437-013; 7) 2038437-014; 8) 20384

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: 1563 units Lot/code info: Model/Catalog/Code # 2022296-001, Installed Product ID 103889-1-Centricity RA600-01461073, UDI UDI Not Required, System ID NDMGRA01; Model/Catalog/Code # 2022296-001, Installed Product ID AH5045-Centricity RA600-00000127, UDI UDI not required, System ID AH5045RW01; Model/Catalog/Code # 2022296-001, Installed Product ID AP0701-Centricity RA600-00000173, UDI UDI not required, System ID AP0701RW01; Model/Catalog/Code # 2022296-001, Installed Product ID 50451-Centricity RA600-02351785, UDI UDI Not Required, System ID HCIT1169080RA600; Model/Catalog/Code # 2022296-001, Installed Product ID 519926-Centricity RA600-00000672, UDI UDI Not required, System ID 519926RW01; Model/Catalog/Code # 2022296-001, Installed Product ID A51043-Centricity RA600-00040985, UDI UDI Not required, System ID A51043117; Model/Catalog/Code # 2022296-001, Installed Product ID 549858-Centricity RA600-01286184, UDI UDI Not Required, System ID MJ1; Model/Catalog/Code # 2022296-001, Installed Product ID RW602-Centricity RA600-00005819, UDI UDI not required, System ID RW60200083; Model/Catalog/Code # 2022296-001, Installed Product ID 80115-Centricity RA600-00005736, UDI UDI not required, System ID 60115TRS01; Model/Catalog/Code # 2033901-001, Installed Product ID 103634-5-Centricity RA600-00099545, UDI UDI Not Required, System ID 520784RA6CLSW3; Model/Catalog/Code # 2033901-001, Installed Product ID 104027-1-Centricity RA600-00102852, UDI UDI Not Required, System ID 928729RA600SW2; Model/Catalog/Code # 2033901-0

Source

Official record: FDA (Device enforcement) ↗

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