Attention MUHC patients who use CPAPs, BiLevel PAPs and ventilators at home: Philips Respironics announces a voluntary recall of some devices

June 22nd, 2021 News

Patients who are followed for hypoventilation by the McGill University Health Centre’s National Program for Home Ventilatory Assistance and patients who have sleep apnea and are followed by outpatient clinics should be aware of a product recall recently announced by Philips Respironics.

The company has issued a voluntary recall of a number of CPAPs, BiLevel PAPs and ventilators due to possible health risks related to the sound-proofing foam used in the machines.  Philips Respironics states they are issuing a voluntary recall “out of an abundance of caution”. To date, there are no reported serious harmful effects, hospitalizations, or deaths.

This recall applies only to some models of Philips Respironics machines that were manufactured before April 26, 2021. They include:

  • Dreamstation
  • Dreamstation Go
  • System One
  • Trilogy (some models only)
  • A-series BiPAP

See the full list of machines here:

www.philips.ca/healthcare/e/sleep/communications/src-update

You may notice black dust inside your humidifier, tubing, or mask. You may have headaches, airway irritation, cough, chest pressure or a sinus infection.

The possible health risks from being exposed to the foam dust include:

  • Irritation (redness or swelling) of the skin, eyes or airways
  • Headache
  • Asthma
  • Kidney and/or liver problems
  • Toxic effect that could lead to cancer

The risk of foam breakdown seems to be higher if:

  • You clean your machine with ozone cleaning products.
  • You have high heat or humidity in your home.

If you are an MUHC patient using one of these devices, please use the questionnaire to be guided on the steps to follow.

IMPORTANT:  If you are a patient followed at the MUHC you can reach us here:  

If you are not followed at the MUHC, please call your doctor and the store where you bought your machine.

 

NOTE:  This recall applies ONLY to Philips Respironics breathing machines.  It does NOT apply to ResMed or Fisher-Paykel breathing machines.

In 2020, Philips Respironics received complaints about the sound-proofing foam for a small number of machines (about 3 in 10 000, or 0.03%). The foam can: 

  • Break down into dust, which could be swallowed or breathed in.
  • Create chemical vapours (a type of gas).

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