Philips Respironics has become aware that Trilogy EVO and Trilogy EV300 devices do not comply with the obstruction alarm requirements specified within ISO 80601-2-12 clause 201.12.4.108 and ISO 80601-2-72 clause 201.12.4.107. The standards specify that the maximum delay from obstruction to alarm shall be no more than 2 breath cycles or 5 seconds, whichever is greater. The current obstruction alarm delay for these devices has been measured up to 65 seconds in certain bench test conditions. This is a delay potentially 60 seconds greater than required by the standards. Recall start date: July 1, 2024
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