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Health Canada Medical devices

Sentinel V11 (Sentinel Cardiology Information Managment System)

Issued December 17, 2025
Issue
Spacelabs Healthcare identified two issues with version 11.6.0 that can result in incorrect patient data being associated with clinical reports, potentially resulting in inaccurate diagnoses and compromised patient safety. Issue A - Incorrect Patient Demographics Issue B - Resting and Rhythm reports assigned to the incorrect patient Users of software version 11.6.0 should contact their local Spacelabs Healthcare representative to update their version of software to 11.6.1.
Hazard description
Performance
Product
Product name
Sentinel V11 (Sentinel Cardiology Information Managment System)
Reference
ID
RA-81374