Philips Respironics Medical Device Recall:
We understand from Philips that they continue to work towards a full launch of their corrective action program in Canada. Philips has not finalized with us any details regarding their corrective action program or the role they want us to have in it. As of today, Philips continues to advise that logistical and supply chain challenges are impacting their ability to support a meaningful remediation program in Canada. As well, this situation is made more difficult by a global shortage of CPAP devices which is negatively impacting supply for all manufacturers in Canada. We will stay connected with this important matter and post on our website any information we receive from Philips including any details we receive about their corrective action program in Canada.
On Tuesday, November 16, 2021, Philips provided an update to their guidance around the continued use of your CPAP. The Philips Medical Recall Letter (“Philips Medical Recall Letter”) is available. The advice is that you talk to your health care provider to decide on a suitable treatment for your condition which may now include “continuing to use your affected device, if your health care provider determines that the benefits outweigh the risks identified in the recall notification”.
We have not vetted nor verified any of the information in the Philips Medical Recall Letter related to the continued use of the CPAP device for accuracy, completeness, efficacy or validity. As well, Health Canada has not yet commented on this recent development but have previously advised that individuals affected by the Recall speak with “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”. For a link to the existing Health Canada recommendations please also visit: https://recallsrappels.canada.ca/en/alert-recall/philips-respironics-recalls-several-models-cpap-and-bilevel-papmachines-and.
We are not responsible for any use of, or reliance upon, the Philips Medical Recall Letter or the Health Canada recommendations but want to let you know that information is available. We strongly recommend that you discuss this matter with your primary health care provider before making any decision about treatment options to meet your individual needs. Further information on this Recall can also be found through the Canadian Thoracic Society and the Canadian Sleep Society.
The Coastal Sleep Team