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Philips Sleep Apnea Device Recall - Click for details
Philips recall - Frequently asked questions

Philips recall - Frequently asked questions

Philips device recall

Key facts

  1. The recall affects Philips C-Series devices and all DreamStation 1 platforms manufactured between November 2009 and April 26, 2021.
  2. Use of the affected device models may pose health risks.
  3. Philips intends to implement a plan for the return, repair or replacement of the affected devices.

What devices are affected by the recall?

The recall affects Philips BiLevel Positive Airway Pressure (BiLevel PAP) devices, Continuous Positive Airway Pressure (CPAP) devices and Mechanical Ventilators manufactured between November 2009 and April 2021, specifically those in the C-Series and all DreamStation 1 platforms.

  • DreamStation Go
  • DreamStation
  • System One
  • DreamStation Expert

For a comprhensive list of the models affectes, visit the machines page.

Please visit the Philips website for more details.

To help you determine whether your device is affected by the recall, find your device’s serial number and use the device identification tool provided online by Philips.

Which Philips products are not affected and why?

Products that are not affected may have different sound abatement foam materials, as new materials and technologies are available over time. In addition, the sound abatement foam in unaffected devices may be placed in a different location due to the design of the device.

Devices from the manufacturers Resmed and Fisher Paykel are not affected by the recall and can continue to be used safely.

Products not affected by this recall are the following:

  • Trilogy Evo
  • Trilogy Evo OBM
  • Trilogy EV300
  • Trilogy 202
  • BiPAP A40 EFL
  • BiPAP A40 Pro
  • M-Series (the only models sold by Biron)
  • DreamStation 2
  • Omnilab (original based on Harmony 2)
  • Dorma 100, Dorma 200 and REMStar SE
  • All oxygen concentrators, respiratory drug delivery products and airway clearance products

For more information, visit the Philips website.

Why is Philips recalling certain devices?

The devices affected by the recall are believed to pose potential health risks.

For more information, visit the Philips website.

What is Philips recommending?

Philips recommends that you discontinue the use of any device affected by this recall and consult your attending physician or pulmonologist as soon as possible to identify alternatives for continued treatment.

For patients using life-sustaining mechanical ventilator devices: DO NOT discontinue or alter your prescribed therapy without consulting a physician or pulmonologist to determine appropriate next steps. Biron invites its patients to consult the recommendations of the American Thoracic Society (ATS), which are based on the severity of the case. The ATS has issued the following statement:

“For patients using life-sustaining mechanical ventilator devices, we would recommend that patients do not stop or alter prescribed therapy until after talking to your physician. Appropriate therapeutic decisions need to balance risks of continuing therapy versus temporarily discontinuing the device while awaiting a reasonable alternative.

For patients on Bi-level PAP and CPAP devices who have severe breathing difficulties, or were very sleepy during the daytime before treatment, have significant pulmonary, cardiovascular or neurologic comorbidity, or who work in safety-critical positions (e.g. professional drivers, pilots, heavy equipment operators), we would recommend that they not stop their prescribed therapy until first discussing with their physician. For other patients, Philips recommends the device should be discontinued and the physician/DME provider be contacted to determine the most appropriate option for continued treatment.”

Can I install a filter so that I can safely use my recalled Philips machine?

The fact that Philips has no procedure for the safe use of antibacterial filters with CPAP and BiPAP machines, along with recent data showing that filters may negatively affect the machine’s performance, leads us to not recommend their use. In addition, the filter does not prevent you from potentially inhaling volatile compounds.

If you have decided to continue using your machine, it is important to stop using it if:

  • Black particles get into the ventilator circuit and/or
  • You experience adverse effects associated with the breakdown of the foam and its volatile compounds, such as:
    • Irritation (skin, eyes, respiratory tract)
    • Inflammation
    • Hypersensitivity
    • Nausea and/or vomiting
    • Headaches and/or dizziness
    • Asthma

Please contact your respirologist at Biron and/or your physician as soon as possible if this is the case.

If my CPAP machine is still under warranty, will Biron replace it at no charge with another device that is not affected by the recall?

If your recalled device was purchased from Biron between March 14, 2021 and June 17, 2021, Biron will replace it free of charge, since it is subject to Biron’s refund policy. If your recalled device was purchased before March 14, 2021 and is still under warranty, it is covered by the warranty of the manufacturer, Philips. In this case, the manufacturer is responsible for honouring the warranty. As agreed, Philips will resolve the recall situation by replacing or repairing your device. For this reason, it is important to register your CPAP or BiPAP machine on Philips’ website so that your request can be processed.

Will affected devices be repaired or replaced?

According to the information obtained, Philips intends to repair or replace the devices affected by the recall. At this time, we are unable to say what will happen with your device (i.e., whether it will be repaired or replaced).

You must register your device in the Philips online registry. Although Biron is committed to registering all recalled devices it has sold, technological challenges make mass registration difficult. It is therefore safer to register your device yourself. Double registering your device will not impact your eligibility for the Philips recall..

Please refer to the appropriate procedure.

When will I receive my new device?

This information is not yet known. Check this page regularly for new updates.

For more information, visit the Philips website.

What should I do in the meantime if my health is at risk?

Biron invites its patients to consult the recommendations of the American Thoracic Society (ATS), which are based on the severity of the case. The ATS has issued the following statement:

“For patients using life-sustaining mechanical ventilator devices, we would recommend that patients do not stop or alter prescribed therapy until after talking to your physician. Appropriate therapeutic decisions need to balance risks of continuing therapy versus temporarily discontinuing the device while awaiting a reasonable alternative.

For patients on Bi-level PAP and CPAP devices who have severe breathing difficulties, or were very sleepy during the daytime before treatment, have significant pulmonary, cardiovascular or neurologic comorbidity, or who work in safety-critical positions (e.g. professional drivers, pilots, heavy equipment operators), we would recommend that they not stop their prescribed therapy until first discussing with their physician. For other patients, Philips recommends the device should be discontinued and the physician/DME provider be contacted to determine the most appropriate option for continued treatment.”

What is Biron doing to help its patients?

Our team continues to communicate with Philips and is working with various groups and suppliers as well as with health professionals in order to give the most appropriate support to its patients.

If you have any other questions, our teams are here to answer them.

Decision Support Tool

Decision Support Tool

The recommendations in this section of Biron’s website are issued by the Centre hospitalier universitaire de Montréal (CHUM). This is an excerpt from the information provided by the CHUM. You can view the original and complete version of these recommendations on the website of the CHUM (available in French only).