Philips Respironics is recalling several models because of reports of the sound-reducing foam breaking down, which could pose potential health risks. Device photos are available on the company's recall website.Philips Respironics Continuous Positive Airway Pressure (CPAP) machines, BiLevel Positive Airway Pressure (BiLevel PAP) machines and mechanical ventilators The recall affects several models manufactured before April 26, 2021. If additional products or safety concerns are identified, Health Canada will take appropriate action and inform Canadians. The Department is also working with Philips to identify strategies to address any device shortages. 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. Health Canada is monitoring the recall and the availability of devices in Canada. Report any health product-related side effects or complaints to Health Canada. ozone) could contribute to potential foam degradation.ĭo not attempt to remove or replace the foam yourself.
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.īe sure to clean your device only according to the manufacturer's Instructions for Use, as the use of non-validated cleaning methods (e.g.
#PHILIPS ENCORE PRO 2 SERIAL NUMBER#
Philips has established a registration process where you can look up your device serial number and begin a claim if your unit is affected. Register your device on the Philips recall website or call its recall hotline at 1-87. 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.įor 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. 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. 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. 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 has issued letters to customers, patients, and distributors with instructions for the recall. 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. Preliminary laboratory analysis by Philips determined that extreme operating temperatures and ozone cleaning methods may increase the breakdown of the foam. 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. The devices include a foam component that reduces sounds from the device. 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.