Health product recall

Trilogy EV300

Last updated

Summary

Product
Trilogy EV300
Issue
Medical devices - Performance
What to do

Contact the manufacturer if you require additional information.

Audience
Healthcare
Industry

Affected products

Affected products

Lot or serial number

Model or catalog number

Trilogy EV300

All lots.

CA2200X12B

Issue

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

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
Industry
Recall class
Type II
Identification number
RA-73404

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