Philips Respironics recalls several models of CPAP and BiLevel PAP machines and mechanical ventilators

Starting date:

July 30, 2021

Type of communication:

Advisory

Subcategory:

Medical Device

Source of recall:

Health Canada

Identification number:

RA-76137

Last updated: 2021-07-30

Summary

• Product: Philips Respironics Continuous Positive Airway Pressure (CPAP) machines, BiLevel Positive Airway Pressure (BiLevel PAP) machines and mechanical ventilators
• Issue: Philips Respironics is recalling several models because of reports of the sound-reducing foam breaking down, which could pose potential health risks. There is no definitive link to adverse health effects based on the company’s preliminary assessments.
• What to do:
  • Talk to your physician or medical device provider first before stopping or changing how you use your product, as the benefits of using these devices may outweigh the risks for many users.
  • Register your device on the Philips recall website or call 1-877-907-7508. Philips has established a registration process where you can look up your device serial number and begin a claim if your unit is affected.
  • Clean your device only according to the manufacturer’s Instructions for Use, as the use of non-validated cleaning methods could contribute to potential issues.

• Issue
• What you should do
• Affected products
• Media enquiries
• Public enquiries

Issue

Philips Respironics (Philips) has recalled several models of its Continuous Positive Airway Pressure (CPAP) machines, BiLevel Positive Airway Pressure (BiLevel PAP) machines and mechanical ventilators in Canada and internationally. The devices include a foam component that reduces sounds from the device. This foam may degrade (break down) into particles which may be inhaled or swallowed by users, or release volatile organic compounds (VOCs) that may be inhaled, which could lead to negative health effects.

Preliminary laboratory analysis by Philips determined that extreme operating temperatures and ozone cleaning methods may increase the breakdown of the foam. The company recommends against product use in temperatures outside of the labelled operating conditions, and the use of non-validated cleaning methods, such as ozone.

Philips has issued letters to customers, patients, and distributors with instructions for the recall. Philips indicates it will replace the foam component with a material that is not affected by this issue, or it will replace affected devices altogether.

Philips reports that they have received a relatively low number of complaints, some of which relate to black debris in the device air path, including the tubing and mask. Some users have reported headache, upper airway irritation, cough, chest pressure, and sinus infection, but it is has not yet been determined if degraded foam particles or VOCs were the cause.

Health Canada considers the benefits of using the affected devices to outweigh the risks for many users, and recommends that users not stop or alter their prescribed therapy before having a discussion with their health care professional.

For ventilators only, Health Canada cautions the use of in-line bacterial filters to mitigate foam particles, as they will not protect against VOC emissions and airflow can be negatively affected if the filter becomes clogged with debris.

What you should do

• Register your device on the Philips recall website or call its recall hotline at 1-877-907-7508. Philips has established a registration process where you can look up your device serial number and begin a claim if your unit is affected.
• If you have an affected product talk to your physician, or medical device provider first before stopping or changing how you use your product, as the benefits of using these devices may outweigh the risks for many users.
• Be sure to clean your device only according to the manufacturer’s Instructions for Use, as the use of non-validated cleaning methods (e.g. ozone) could contribute to potential foam degradation.
• Do not attempt to remove or replace the foam yourself.
• Report any health product-related side effects or complaints to Health Canada.

What Health Canada is doing?

Health Canada is monitoring the recall and the availability of devices in Canada. The Department continues to work with the manufacturer to further assess potential health risks, any future design or material changes that may be proposed, and the appropriateness of the company’s corrective actions.

The Department is also working with Philips to identify strategies to address any device shortages. If additional products or safety concerns are identified, Health Canada will take appropriate action and inform Canadians.

Affected products

Media enquiries

Health Canada
(613) 957-2983
hc.media.sc@canada.ca

Public enquiries

(613) 957-2991 
1-866 225-0709
hcinfo.infosc@canada.ca