Philips recall - Frequently asked questions

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 devices page.

Please visit the Philips website for more information.

To help determine if your device is affected by the recall, locate your device’s serial number and use Philips’ online device identification tool.

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.

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.

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.”

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.

Philips intends to replace or repair the devices covered by the recall. At this time, we know that DreamStation 1 continuous positive airway pressure (CPAP and Auto CPAP) devices, including the Pro, Expert and Auto models, will be replaced with either a DreamStation 2 or a new DreamStation 1. Philips has also begun replacing BiPAP devices (Auto Dreamstation and AVAPS model). It is Philips who will determine whether your device will be replaced with a new DreamStation 2 or DreamStation 1. Biron has no control over this decision and is not informed of Philips’ decision-making process in this regard.

Replacement devices will be sent to Biron, which will then send them to the patients concerned. Each replacement device is associated with a serial number of a device to replace and Biron will assign the replacement device to the patient based on this information. Philips will send devices to patients based on the order in which they are registered.

See the information on the replacement process. See the Update section to stay informed of the latest news related to the Philips recall.

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

In any case, to take advantage of the recall you must keep your affected 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 procedure for returning your device at no charge will be explained to you when you receive your replacement device. It is very important to read all the documents that you receive.

You must also register your device in Philips’ online registration system. It is important to keep the confirmation number for your device registration, which Philips will send to you.

You only need to register once. If you receive any further message from Philips asking you to register and you have already done so, you may disregard this request.

Please refer to the procedure for registering your device.

To simplify the exchange, it will be done online through our sleep store. Each patient will receive a letter that includes a link to our store, where they can order their replacement device. The device will be sent by mail to the post office nearest the patient’s home.

To complete the exchange, and before the replacement device is shipped, the patient must agree to return the recalled device to Biron within 15 days after receiving the new one. A prepaid FedEx return slip will be provided (plan for online activation process for patients), along with instructions on how to proceed.

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.

Philips is replacing devices based on availability of replacement devices, either a DreamStation 2 or a refurbished DreamStation 1 with FDA-approved sound-absorbing foam. Instructions will be sent to the patients concerned on how to proceed.

Since Philips will send us replacement devices in small batches, we cannot replace all devices at once. Patients will be asked to exchange their devices in the order in which they were registered.

Please note that Biron is unable to tell you where you stand on Philips’ list of people who have registered for the recall. Rest assured that you will be contacted immediately when your turn arrives.

Replacement devices will be distributed according to Philips’ instructions, i.e. each replacement device is associated with the serial number of a device to be replaced, and the recall will be conducted on this basis from now on.

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

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.”

To learn more about this topic, please see this page from the American Thoracic Society:

We want to replace or repair the devices affected by the recall as quickly as possible, but we are dependent on Philips’ schedule, the number of devices they send us, as well as the replacement rules they have established, which are based on the order in which you registered for the recall.

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.

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

• 1 855-SOMMEIL
• Chat (weekdays from 8 a.m. to 4 p.m.)
• boutique@biron.com