Recall of Philips manufacturer’s CPAP devices

Announced on June 14, manufacturer Philips Respironics issued a voluntary recall of continuous and non-continuous ventilators (certain CPAP devices, dual-stage PAP and ventilators) due to two issues with polyurethane soundproofing foam polyester-based (PE-PUR) used in these devices: 1) PE-PUR foam can break down into particles that can enter the air circuit of the device and be ingested or inhaled by the user, and 2) PE-PUR foam can give off gases of certain chemicals.

Out of caution and based on the information available, Philips has raised the potential health risks associated with the noise-canceling foam used in certain Philips Continuous Positive Airway (CPAP), Two-Stage Positive Airway, and mechanical fans.

“Potential health risks include exposure to degraded soundproofing foam, for example caused by unapproved cleaning methods such as ozone, and exposure to chemical emissions from the foam. “

Although Groupe Medicus is not responsible for the recall, everything is done to support you. The situation is monitored very closely on a daily basis and each of us, especially your respiratory therapists, are fully committed to maintaining constant communication with you. Please see the Philips website for details.

The recall issued by Philips involves Philips two-level positive pressure (two-level PAP), continuous positive airway pressure (CPAP) and mechanical ventilator devices manufactured between November 2009 and April 2021.

Two-tier CPAP and PAP devices

Mechanical fans

Please see the Philips website for details. To help you determine if your device is affected by the recall, find your device’s serial number and use the Philips Online Device Identification Tool.

In order to carry out the recall, Philips has set up an online platform on which to register the devices affected by the recall.

You must register your device on this platform to ensure that your device will be supported by Philips when the time comes.

People who want to enroll their device must:

• Validate that the sleep apnea therapy device model is affected by the recall.
• Have the serial number of the device handy.
• Go to the Philips website to register the device. Only one device can be enrolled at a time.
• Enter the serial number of the device in the space provided and click on the blue “check unit” button. A message confirming that your device is eligible for the recall will appear on the screen.
• Fill out the form and submit it.

Last updated: February 28, 2022

Rest assured that our team is in constant communication with Philips and works in collaboration with various stakeholders in the field to put in place a clear action plan and a procedure aimed at your support. Although the delays are information beyond our control, the manufacturer Philips is currently beginning to replace the devices affected by the recall issued on June 14.

Currently only Dreamstation1 CPAP exchange, PRO, Auto and Expert models are being replaced.

Patients affected by this recall will receive a communication from their respiratory therapist when their turn comes, as well as the procedure to follow.