Company recalls CPAP, BiLevel PAP machines and ventilators due to possible health risks
A medical supply company is recalling several models of its Continuous Positive Airway Pressure (CPAP) machines, BiLevel Positive Airway Pressure (BiLevel PAP) machines, as well as mechanical respirators.
Health Canada announced the recall on Friday, saying that Philips Respironics is recalling these devices due to reports of the sound-reducing foam breaking down. This poses potential health risks as the foam can break down into particles, which could be inhaled or swallowed, or release volatile organic compounds.
Philips has also determined that the breakdown of the foam can be increased by extreme operating temperatures or ozone cleaning methods. Therefore, the company advises that people don’t use the product in temperatures outside of the labelled operation conditions, and that people don’t use non-validated cleaning methods.
The recall impacts a number of models of the devices manufactured before April 26, 2021. A full list can be found online.
Philips has sent letters to customers, patients and distributors regarding the recall, indicating that it will replace the foam component or replace the device altogether,
The company has received a relatively low number of complaints. Some customers have reported headaches, upper airway irritation, coughs, chest pressure and sinus infections. However, it has yet to be determined whether the degraded foam or the volatile organic compounds were the cause of the symptoms.
Health Canada said the benefits of using the recalled devices outweigh the risks for a lot of people. The health agency suggests that users do not stop or alter their prescribed therapy without talking to a medical professional.
For ventilators only, Health Canada advises against the use of in-line bacterial filters to deal with the foam particles, because they won’t protect against volatile organic compound emissions, and airflow can be affected if the filter becomes clogged.
Anyone who is impacted by the recall should register their device on the Philips recall website or call the hotline at 1-877-907-7508. They should also clean their device according to the manufacturer’s instructions and report any possible side effects to Health Canada. The government also reminds people not to try to remove or replace the foam.
Health Canada is monitoring the situation and the availability of devices in Canada. The health agency is working with the manufacturer to assess potential health risks, any future designs or material changes, and the company’s corrective actions.
Health Canada is working with Philips to come up with strategies to deal with device shortages, as well.