December 2021 : Field Safety Notice ICSMA-21-343-01 - SSO Password Vulnerability for Cardiology Products : Unauthorized access to application functions and patient data

Field Safety Notice ICSMA-21-343-01 - SSO Password Vulnerability for Cardiology Products : Unauthorized access to application functions and patient data.

 

 

Affected Medical Device : 

Q-Stress® System, XScribeTM System, HScribeTM System, Vision ExpressTM System, Diagnostic Cardiology SuiteTM (DCS), Connex® Cardio ECG, RScribeTM System

 

MDA Reference Number : MDA/FCA/2021-P172

 

Description :

Q-Stress, XScribe, HScribe, Vision Express, DCS (Connex Cardio) and RScribe, systems configured to use Single Sign-on via their modality manager configuration settings, are affected by an improper authentication defect.

 

Local Establishment Contact Detail :

Kah Syuan LEE
Senior Specialist, QA/RA
ASEANNA
GF101-2, TOWER 2, WISMA AMFIRST, SS7/15, 47301 PETALING JAYA, SELANGOR

 

Email : [email protected]