Voluntary Recall Information


Philips Respironics Sleep and Respiratory Care devices

Registration for affected CPAP and BiPAP devices in the US and Canada closed on December 31, 2024. The Patient Portal will remain open for registered US patients until June 30, 2025.

Important information for clinicians

Sleep Therapy information

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If you or your patients have registered an affected device and are still waiting for a replacement, it is likely because they may need to take specific action in the Patient Portal to receive their replacement.

 

Please note: The US Patient Portal will remain open until June 30, 2025.  This means that effective July 1, 2025, patients will not be able to access the portal. 

Ventilation information

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The remediation of ventilator devices remains ongoing. Philips Respironics will communicate with Durable Medical Equipment providers (DMEs) as updates become available. Please visit our ventilation news and updates page for the latest information.

Latest Testing Updates

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Test results and conclusions for home sleep therapy devices

 

Based on the results to date, Philips Respironics and the third-party experts concluded that use of the sleep therapy devices is not expected to result in appreciable harm to health in patients. Further testing related to the sleep therapy and ventilator devices remain ongoing.

 

Since the start of the test and research program, Philips Respironics has worked cooperatively with the FDA on the program and to publish regular test updates as agreed with the FDA. The latest update can be found here.

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Ozone and UV light cleaning products are not currently approved cleaning methods for sleep apnea devices or masks and should not be used.

At Philips, patient safety and quality are at the heart of everything we do

Latest updates

Explained: The voluntary Philips Respironics sleep and respiratory care devices recall*

 

* This is a voluntary recall notification in the US and field safety notice in other countries

Explained: The Philips Respironics Consent Decree

April 4, 2024

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