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Health Canada Medical devices

Arctic Sun 5000 and Arctic Sun Stat

Issued July 12, 2024
Issue
An internal investigation has determined that alarm 113 may not alert as expected when the device fails to reach the correct target water temperature while the device is operating in patient control mode. Recall start date: June 27, 2024
Hazard description
Performance
Product
Product name
Arctic Sun 5000 and Arctic Sun Stat
Reference
ID
RA-75812