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Health Canada Medical devices

Trilogy EV300

Issued March 29, 2023
Issue
Philips Respironics has discovered that accuracy of delivered oxygen may deviate below the required tolerance of 5% from setpoint when providing high concentration oxygen therapy. Additionally, if equipped, the internal FioO2 sensor may indicate a value higher than the device is actually delivering. This may vary based on the patient's lung capacity, lung resistance, use of a particulate filter, or circuit configuration. In the worst case, this may lead to under delivery of oxygen. Recall start date: March 3, 2023
Hazard description
Performance
Product
Product name
Trilogy EV300
Reference
ID
RA-73404