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Health Canada Medical devices

Trilogy Ventilators

Issued December 21, 2022
Issue
The replacement silicone sound abatement foam installed into the Trilogy 100 and Trilogy 200 devices identified in this letter may separate from the plastic backing to which it is attached. If this were to happen, the foam could potentially block air inlet, which could result in a reduction in delivered therapy volume or pressure and could cause the device to alarm. Additionally, Philips Respironics has observed residual pe-pur sound abatement foam in some devices that were returned to the field. these cases were limited but further exposure to pe-pur sound abatement foam should be avoided. Recall start date: December 16, 2022
Hazard description
Performance
Product
Product name
Trilogy Ventilators
Reference
ID
RA-72409