Official recall record
Trilogy EVO and EV300 (ref 75855)
- Issuing authority
- Health Canada — Medical Devices
- Published
- 2024-07-24
- Country of alert
- Canada
- Alert level
- Type II
- Alert type
- recall
What the authority reported
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
What to do
Follow the instructions in the official notice — recall remedies (refund, repair, replacement, or disposal) are defined by the issuing authority and the responsible business, and they differ per recall. Do not rely on summaries, including this one.
Record last checked against the registry on 2026-05-31.