Skip to contentSkip to navigation
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.

You can also see Health Canada’s website on the recall.

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.

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 know that the DreamStation 1 CPAP and AutoCPAP machines, including the Pro, Expert and Auto models, will be replaced with a DreamStation 2 machine.

Please see the details on the replacement process.

For the other recalled devices, Philips has not provided any information as to when it will remedy the situation or whether it will replace or repair the devices.

In any case, to take advantage of the recall, it is essential that you keep your recalled device, as it must be returned to Philips when the time comes, naturally if you are offered a repair, but also if you are offered a replacement. The return procedure will be explained to you when you get your replacement CPAP machine. It is very important to read all the documents that you receive.

You must register your device in the Philips online registry.

Please refer to the appropriate procedure.

How do I exchange my CPAP machine?

To make the exchange easier, it will be done online through our Sleep Boutique. When their turn comes, each patient will receive a letter containing a link to our Boutique to order their replacement machine. This unit will be mailed to the post office closest to the patient’s home.

To complete the exchange, and before the replacement device is sent, the patient must agree to return the defective CPAP machine to Biron within 30 days after receiving the new device. A prepaid return slip will be provided, along with instructions on how to proceed.

I do not have access to a computer and am not comfortable exchanging my CPAP machine online without assistance. Can you help me?

We are available to assist you if you need help. If we do not have an email address to reach you, our customer service will contact you by phone, until we have you on the line, in order to exchange your device. Please note that to avoid multiple return calls, we will not leave a voice message.

If you have any questions, you can contact us via chat or by calling our customer service at 1-833-590-2713.

When will I receive my new device?

This information is not yet known. What we know so far is that Philips is beginning to replace only DreamStation 1 models with the DreamStation 2. Instructions will be sent to affected patients so that they can proceed.

Since Philips will send us replacement machines in small shipments, we cannot replace all devices at the same time. Patients will therefore be asked to exchange their CPAP machines in the order in which they were registered. Replacement machines will then be distributed on a first come, first served basis. Consequently, it is important to initiate the process of replacing your device as soon as you receive the letter from Biron in this regard.

We do not yet know when Philips will activate the replacement or repair process for the other recalled models.

Please visit the Philips website for more details on the recall.

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.”

You can also refer to Health Canada’s website on this topic.

I have very severe apnea. Can you give me priority when replacing the devices?

We wish to replace or repair the CPAP machines affected by the recall as quickly as possible, but we are dependent on the pace and quantity of the devices that Philips sends us.

Until you receive a compliant device, recommendations for your treatment and condition remain the same, whether you discussed them with your doctor or they are in line with the information provided by Health Canada.

Your respiratory therapist is also available to support you if needed.

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).