Trilogy EV300

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