GE Healthcare: GE Healthcare Centricity PACS-IW (PACS-IW), Model Numbers: 1) 2042988-001; 2) 2049587-009; 3) 2049587-011; 4) 2049587-012; 5) 2049587-015; 6) 2049588-012 ; 7) 2052829-001.

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: 82 units Lot/code info: Model/Catalog/Code # 2042988-001, Installed Product ID 707509-Centricity PACS-IW-01452391, UDI UDI Not Required, System ID HCIT4250187IW; Model/Catalog/Code # 2042988-001, Installed Product ID 613493-Centricity PACS-IW-02292544, UDI UDI Not Required, System ID HCIT4507688PACS; Model/Catalog/Code # 2049587-009, Installed Product ID 4276-1-Centricity PACS-IW-00558274, UDI UDI Not Required, System ID PACS-IW-168; Model/Catalog/Code # 2049587-011, Installed Product ID 12830-1-Centricity PACS-IW-00558312, UDI UDI Not Required, System ID PACS-IW-477; Model/Catalog/Code # 2049587-011, Installed Product ID 4352-1-Centricity PACS-IW-00558316, UDI UDI Not Required, System ID PACS-IW-89; Model/Catalog/Code # 2049587-012, Installed Product ID 100858-1-Centricity PACS-IW-00558426, UDI UDI Not Required, System ID PACS-IW-412; Model/Catalog/Code # 2049587-012, Installed Product ID 4294-1-Centricity PACS-IW-00558379, UDI UDI Not Required, System ID PACS-IW-304; Model/Catalog/Code # 2049587-012, Installed Product ID 13039-1-Centricity PACS-IW-00558385, UDI UDI Not Required, System ID PACS-IW-313; Model/Catalog/Code # 2049587-012, Installed Product ID 4744-1-Centricity PACS-IW-00558373, UDI UDI Not Required, System ID PACS-IW-444; Model/Catalog/Code # 2049587-012, Installed Product ID 101216-1-Centricity PACS-IW-00558356, UDI UDI Not Required, System ID PACS-IW-544; Model/Catalog/Code # 2049587-012, Installed Product ID 4361-1-Centricity PACS-IW-00558343, UDI UDI Not Required, System ID PACS-I

Source

Official record: FDA (Device enforcement) ↗

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