Voluntary Recall Information

Philips Respironics Sleep and Respiratory Care devices

News and Updates > Understand the steps we take to ensure the safety of your replacement CPAP or BiPAP device

Understand the steps we take to ensure the safety of your replacement CPAP or BiPAP device

Posted: December 14, 2022
Updated: January 13, 2025

While we work to provide replacement devices as quickly as possible, we want to share the steps we are taking to ensure your First Generation DreamStation replacement device is safe to use so you can be confident in your new device.

The differences between the polyester-based polyurethane (PE-PUR) sound abatement and the sound abatement foam used in new and recertified devices
How we replace the interior air pathway, including the blower and the foam
How the filter at the back end of your replacement device may change color naturally over time, and how often to replace it
How we assess affected devices and replace any external components that have been damaged, and do our best to correct cosmetic blemishes
How all remediated devices will include a label at the bottom showing REV (short for revision) 15 or higher. This indicates that the device has been remediated to include silicone foam.

While affected devices contained a polyester-based polyurethane (PE-PUR) sound abatement foam component, the sound abatement foam in new and recertified CPAP, BiPAP and Trilogy devices is a silicone foam that has met all applicable industry testing standards, including particulate and Volatile Organic Compounds (VOCs) emissions testing.

This replacement reinstates the two-year warranty and your device’s manufacturing warranty has been adjusted to cover all labor and materials to repair your replacement device free of charge.

All remediated devices will include a label at the bottom showing REV15 or higher. This indicates that the device has been remediated to include silicone foam.

Example product label showing remediation code

Product label example

Regular device cleaning and maintenance is important for your therapy

We want you to be confident you are cleaning your device properly. For detailed information about caring for replacement devices, please refer to the device’s User Manual and Accessory Cleaning and Inspection Instructions that come with the device.
It is important that you use only the cleaning methods approved for your device. Ozone and UV light cleaning products are not currently approved cleaning methods for sleep apnea devices or masks and should not be used. Please also refer to the FDA safety communication titled: “Ozone and UV light: Potential Risks associated with the use of ozone and ultraviolet (UV) light for cleaning CPAP machines and accessories.”

Need further assistance?

Please contact your Durable Medical Equipment provider (DME) for additional support. To find a DME in your area, please reach out to your physician or insurance provider.

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