Medical Device Recall Information


Philips Respironics Sleep and Respiratory Care devices

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Replacement device safety information

August 5, 2022

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

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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.

 

  • All recertified devices include a new blower and air pathway and are cleaned and disinfected.
  • While your recertified device may show some external cosmetic blemishes and a different manufacturing date than your original device, it has undergone recertification and validation procedures to ensure that applicable standards of safety, performance and quality are met.
  • 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 and is safe to use.

Example product label showing remediation code

Product label example

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Regular device cleaning and maintenance is important for your therapy

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