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Health Canada Medical devices

St80i Stress Test System

Issued January 31, 2022
Issue
When patient demographic information is entered into the system and the patient information is saved or exported to a folder, in very rare situations, the demographic information that is displayed is that of the previous patient instead of the current patient resulting in patient data mismatch. There have been complaints related to this issue, but to date there have been no reports of patient injury. Recall start date: Dec 20, 2021
Hazard description
Software defect
Product
Product name
St80i Stress Test System
Reference
ID
RA-63874