Health product recall

Trilogy Ventilators

Last updated

Summary

Product
Trilogy Ventilators
Issue
Medical devices - Performance
What to do

Contact the manufacturer if you require additional information. 

Audience
Healthcare

Affected products

Affected products

Lot or serial number

Model or catalogue number

Trilogy 200, Canada

Not applicable.

CA1032800
CA1032800B

Trilogy 100 Ventilator-Canada

Not applicable.

CA1054096
CA1054096B

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

 

Additional information

Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Anaesthesiology
Companies

Respironics Inc. Also Trading As Philips Rs North America Llc

1001 Murry Ridge Lane, Murrysville, Pennsylvania, United States, 15668

Published by
Health Canada
Audience
Healthcare
Recall class
Type I
Identification number
RA-72409

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