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Health Canada Medical devices

Servo-N

Issued February 2, 2024
Issue
A limitation of the intended performance of Servo-N during high frequency oscillatory ventilation (HFOV) when using the Fisher & Paykel Neonatal Circuit (950N81*) and the humidifier FP950. The use of a relatively small endotracheal (ET) tube in relation to body weight and in combination with the Fisher & Paykel Neonatal Circuit* that is used with the FP950 humidifier limits the delivered Pampl and therefore reduces the delivered VThf. Recall Start Date: January 22, 2024
Hazard description
Performance
Product
Product name
Servo-N
Reference
ID
RA-74999