Message from the Canadian Thoracic Society, the Canadian Sleep Society, and the
Canadian Society of Respiratory Therapists
September 19, 2022
Health Canada posted an alert on Friday, September 16, 2022 informing patients, caregivers, and health care providers that Philips Respironics recalled certain masks used with bilevel positive airway pressure (also known as Bilevel PAP, BiPAP, or BPAP) machines and continuous positive airway pressure (CPAP) machines due to a serious safety concern. The recalled masks have magnets and can cause potential injuries or death when use of a recalled mask with magnets interferes with certain implanted metallic medical devices and metallic objects in the body.
These potential adverse events can occur in people who use the masks, or in people near a person using the mask. Additionally, the recalled Philips Respironics masks may be used with other manufacturers’ BiPAP and CPAP machines. Users of any BiPAP or CPAP machine should check to see whether their mask is one of the recalled Philips Respironics masks.
Recommendations from Philips Respironics:
- Patients should stop using the affected mask if the implant/medical device is contraindicated against the mask magnets.
- Patients should consult their physician immediately to determine if another mask can be used for their therapy.
- In the interim, switch to a non-magnetic mask if available, for continued therapy.
- Patients should properly dispose of the mask that has magnets after an alternative is obtained.
These masks may continue to be used according to the updated instructions and labeling if patients or people in close proximity to them do not have implanted metallic medical devices or metallic objects in the body.
The Canadian Thoracic Society, Canadian Sleep Society and the Canadian Society of Respiratory Therapists are monitoring this situation closely. Should additional information regarding this recall becomes available, we will inform you. Please visit the CTS/CSS/CSRT websites for updates.
Links:
Health Canada Product Recall
English: https://recalls-rappels.canada.ca/en/alert-recall/respironics-masks#tablefield-node-64545-field_affected_products-0
French: https://recalls-rappels.canada.ca/fr/avis-rappel/respironics-masks
U.S. Food & Drug Administration
https://www.fda.gov/medical-devices/safety-communications/certain-philips-respironics-masks-bipap-cpap-machines-recalled-due-safety-issue-magnets-may-affect