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Health Canada Medical devices

BeneVision N1 Patient Monitor

Issued August 28, 2025
Issue
Mindray has identified that, under rare circumstances, using the BeneVision N1 Patient Monitor with software versions 01.60.00.01 and 01.61.00.01 as a multi-parameter module in conjunction with a host monitor may result in the activation of an abnormal alarm pause. This can occur if the alarm pause button is pressed twice rapidly on either the N1 or the host monitor. Recall start date: August 19, 2025
Hazard description
Performance
Product
Product name
BeneVision N1 Patient Monitor
Reference
ID
RA-77995