Philips Urgent Field Safety Notice
Please review the following information with all members of your staff who need to be aware of
the contents of this communication. It is important to understand the implications of this
communication.
Health Canada Advisory Update – Philips Respironics CPAP and BiLevel PAP machines and mechanical ventilators
Health Canada is providing an update on the progress of Philips Respironics’ (Philips) recall of several models of CPAP and BiLevel PAP machines and mechanical ventilators in Canada. The Department is closely monitoring the company’s progress in resolving the safety issue and implementing a repair and replacement program for affected devices in Canada. Health Canada’s safety recommendations have not changed from its July 2021 advisory.
You can report any suspected adverse reactions to drugs and other health products to the Canada Vigilance Program by visiting the Adverse Reaction and Medical Device Problem Reporting page.
Disclaimer
Health professional or public advisories are made available on Health Canada’s Web site on an ad hoc basis as a service to health professionals, consumers, and other interested parties. These advisories may be prepared in collaboration with Directorates of Health Canada’s Health Products and Food Branch, which includes pre-market and post-market areas, as well as market authorization holders and other stakeholders.
SAFETY NOTIFICATION – Potential Risks Associated With The Use of Ozone and Ultraviolet (UV) Light Products
Please see below for important safety information regarding potential risks associated with the use of ozone and ultraviolet (UV) light products to clean CPAP machines and accessories
FDA
Resmed
ResMed NA customer letter re Philips RecallFSN
Resmed Information regarding Philips’ recall – Frequently Asked Questions […]
MESSAGE FOR VEP CLIENTS USING THE PHILIPS TRILOGY 200 AND BIPAP A40
We have recently learned that Philips Respironics issued a voluntary recall and safety notification for specific ventilator devices due to potential health risks relating to the sound abatement foam used in the devices –
https://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2021/75887r-eng.php
https://www.philips.ca/healthcare/e/sleep/communications/src-update
The VEP has not yet been provided with a list of affected serial numbers and we are working with our vendors to determine which devices may be affected and which solutions may be available.
In the meantime:
Please speak with your health care team and DO NOT stop or alter your prescribed therapy unless advised by your health care team.
DO NOT use ozone cleaners for your ventilators. […]
Urgent Field Safety Notification Stellar 100/150 Device failure may lead to alarm malfunction
December 27, 2019 
Re: Urgent Field Safety Notification
Stellar 100/150 Device failure may lead to alarm malfunction
Dear Ontario Ventilator Equipment Pool (VEP) client, parent, caregiver, substitute decision maker (SDM):
The VEP received notification on December 20th 2019 from ResMed Inc. of an Urgent Field Safety Notification.
Stellar Field Safety Notification 05Dec19
Stellar Avis De Sécurité urgent 05Dec19
You are receiving this letter because our records indicate you have a model ResMed Stellar150 bilevel device with a serial number in the affected serial number range.
Description of the Issue:
ResMed Inc. received a confirmed case of an alarm buzzer not working under the following circumstances: the device has a failed electronic component and, the device is stored without AC power connected for more than 36 hours, leading to full depletion of the battery, and the device powers on automatically when connected to AC power without pressing the power switch. The identified issue is a combination of software and a component […]
