Official recall record

Philips Respironics Continuous Positive Airway Pressure (CPAP) machines, BiLevel Positive Airway Pressure (BiLevel PAP) machines and mechani

What the authority reported

UPDATE (2024-07-05): Update on Philips Respironics recall of several models of CPAP and BiLevel PAP machines and mechanical ventilators Since 2021, Philips Respironics (Philips) has established a registration portal, as a part of their repair and replacement program, for affected CPAP and BiLevel PAP machines and mechanical ventilators in Canada. Philips Respironics plans to close its registration portal at the end of December 2024, with the goal of completing its repair and replacement program in Canada by the end of June 2025. As a result, the company is asking all customers who have not yet registered their devices to do so as soon as possible. As noted in previous communications , consumers with an affected device should register their device at the Philips recall website or by calling 1-877-907-7508. If you are not sure whether your product is affected, during the registration process, you can look up your device serial number and begin a claim if your unit is affected. The recall only affects models manufactured before April 26, 2021. Once consumers have completed the registration process, they need to contact their health care provider and/or durable medical equipment provider to initiate the remediation process, who will coordinate device repairs and replacements, and help patients secure and set up medical equipment for home use. To inquire about the status of the remediation, you can contact Philips at [email protected] . If you currently own a recalled device and do not have an account with a health care provider or durable medical equipment provider and do not have a completed device registration, Philips advises you to : Conduct an internet search for "Canadian CPAP providers near me," and Contact a provider listed in the results of the search to arrange for the replacement of the device. Alternatively, if you have completed your device registration, you can connect with a durable medical equipment provider through Philips. Health Canada continues to closely monitor the company's progress in resolving the safety issue and implementing a repair and replacement program for affected devices in Canada. UPDATE (2022-07-27): Update on Philips Respironics recall of several models of CPAP and BiLevel PAP machines and mechanical ventilators Health Canada is providing an update on the progress of Philips Respironics' (Philips) recall of several models of CPAP and BiLevel PAP machines and mechanical ventilators in Canada. Since communicating about the recall in July 2021 (see below), Health Canada has been receiving questions from individuals who rely on these devices. The Department wants to reassure patients and their families that their health and well-being is a priority. The Department is closely monitoring the company's progress in resolving the safety issue and implementing a repair and replacement program for affected devices in Canada. Health Canada's safety recommendations have not changed from its July 2021 advisory. Progress on remediation plan to date: Philips has confirmed that it is repairing or replacing all devices affected by this recall, irrespective of the age of the device. Philips may replace devices with the same model, or a different Philips device that will meet the needs of the patient. Philips has advised Health Canada that it expects to complete its repair and replacement program in Canada by the end of 2023. As part of the company's remediation plan, Philips will submit licence amendments for any proposed device design or material changes to address the foam degradation and off-gassing issues. The submissions must provide evidence that the safety concern has been addressed and that the changes are safe. While Health Canada cannot compel a company to submit a licence amendment, or to submit it within a certain timeline, the Department is prioritizing and expediting the review of each of these amendment packages when it receives them.

What to do

Follow the instructions in the official notice — recall remedies (refund, repair, replacement, or disposal) are defined by the issuing authority and the responsible business, and they differ per recall. Do not rely on summaries, including this one.

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