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Important Notice: Voluntary recall by Philips for certain PAP devices

This notice from Asheville Pulmonary and Critical Care Associates contains an important health and safety update. Please read this notice in its entirety. 

Philips has issued a voluntary recall for specific Philips Respironics CPAP, bilevel PAP, and mechanical ventilator devices. The recalled machines include the DreamStation devices that are used to treat obstructive sleep apnea. (The newer DreamStation 2 is not affected.) Philips has begun a process to repair and replace affected devices. How long this process will take is unclear.

The recall is related to the type of foam used to reduce the noise made by the devices. Over time, the foam inside the machine may fall apart into black particles. These particles can enter the humidifier, 

tubing and mask. As a result, you may inhale the particles when using the device. Testing by Philips also found that the foam can produce unsafe chemical levels. These “volatile organic compounds” are released as gases. Testing results suggest these emissions taper off during the initial days of use of a new device.

Philips reports that the potential risks to you include:

  • headache
  • skin or eye irritation
  • asthma
  • irritation of the airway
  • nausea or vomiting

Philips reports that in 2020 the complaint rate for foam particles was low (0.03%). To date, there have been no reports of death. Philips has received no complaints related to chemical exposure.

What should you do if you use a Philips PAP device?

  • Visit the Philips recall webpage for current information.
  • Use the Philips registration process to look up your device serial number.
  • Begin a claim with Philips if your unit is affected.
  • Call Philips at 877-907-7508 if you have questions about your device.
  • Philips also advises you to avoid using ozone products to clean your PAP device. Philips reports that ozone-related cleaners may help wear down the foam in the device.
  • If your recalled device is a life-sustaining mechanical ventilator:
    • DO NOT stop using the device.
    • Talk to your medical provider to discuss your options.
  • If your recalled device is a CPAP or BPAP device for sleep apnea:
    • The FDA advises you to talk to your health care provider to decide on a suitable treatment for your condition.
    • The American Academy of Sleep Medicine advises you to contact your medical provider as soon as possible. Your medical provider can help you determine if you should continue or discontinue treatment. Your provider may prescribe a new PAP device for you. Your provider also may discuss other treatment options with you.

Please contact Asheville Pulmonary at 828-255-7733 or the Mission Sleep Center at 828-213-4670 for more information about this notice or to discuss your treatment options.

Updated 8/2/2021