CPAP Recall Notice

Update: September 1, 2021 – Philips starts repair and replacement program.
Click here to learn more

Update: November 2021 – Click here to learn more

Update: February 2024 – Click here to learn more

Dear Patients,

We (your sleep medicine providers), understand the confusion and anxiety surrounding the recent Philips Respironics PAP (The Manufacturer) device recall. We are attempting to sort out the details of this complex situation and how best to provide information to our patients.  With the sheer volume of people on PAP devices, it has been challenging to reach out to individuals as quickly as you and we would like. We are planning methods to connect to more people at once.

DUE TO THE NATURE OF THE SITUATION, THIS INFORMATION SHOULD NOT BE SEEN AS MEDICAL RECOMMENDATIONS.  EVERY SITUATION IS DIFFERENT. THE FOLLOWING IS FOR INFORMATIONAL PURPOSES ONLY.

Possible symptoms of device problems:

This is taken from the manufacturer’s website, reporting a 0.03% (roughly 1 out of 3000 users) complaint rate in 2020.
Irritation (skin, eyes, and respiratory tract), inflammatory response, headache, unpleasant smell, dizziness, asthma, along with possible longer term adverse effects, including “possible toxic and carcinogenic effects”, related to chemicals released from the foam insulation (see below). As regards the latter, Philips Respironics website also states, “Philips has received no reports regarding patient impact related to chemical emissions.” We do not know the degree of risk, how much or significant it is, and over what period it may develop. For individual patients, it is also often unclear if the above symptoms are related to the device versus other patient-related reasons for the symptoms.

Why this is happening:

The manufacturer indicates that the problem is from the foam insulation in the motor box, used to reduce motor noise. In affected devices, the foam may deteriorate, with small black flecks of the foam getting into the air from the unit. In addition, chemicals released from the foam (off gassing) may also lead to problems. We (medical opinion) expect these symptoms to be experienced mostly with nighttime and morning use of the device, rather than developing later in the day or persisting all day.

What to expect and what we do not know at this time:

We do not know how the manufacturer’s plans to fix the problem (remediation). This may include replacement of the foam and/or replacement of the affected PAP device. We think that it will take some time (opinion: months to a year or longer), to fully correct the problem, given the huge number of devices that are affected in the United States and across the world.

Manufacturer recommendations:

  • *Register your device on their website (see below) or by calling 1-877-907-7508
  • Stop using any ozone generating cleaning device
  • Follow the device instructions for use of approved cleaning methods
  • They have also made the blanket statement to stop treatment, and follow up with your provider
    • Stopping treatment is not a realistic strategy for many people as there is no ideal short-term solution for the majority of people.
    • The “best” decision for the individual may be complicated.
    • There are risks to stopping treatment (such as the reasons you are using PAP (health and/or symptoms).
    • We do not have the information needed to properly determine your individual risk of continuing treatment with your current device.
    • Alternative treatment options are limited by expense issues and availability.

Based on information from the American Academy of Sleep Medicine and American Thoracic Society:

Situations when you may choose to continue treatment: You,

  • cannot sleep without your device because the sleep quality would be significantly impacted, or your daytime functioning would be impaired
  • have Moderate or Severe sleep apnea
  • have a history of heart disease, heart failure, or arrhythmia
  • have a history of stroke or TIA (ministroke)
  • are using PAP for respiratory failure or hypoventilation
  • are required to use treatment for a CDL or pilot’s license

Possible short-term approaches:

  • using an older device, if you have one, and it is not on the recall list
  • using your travel device, if you have one, and it is not on the recall list
  • switching to another form of treatment (oral appliance, or pursuing surgical options; avoiding sleeping on your back)
    • these may be appropriate for some people, but there are side effects and risks and/or varied success rates with these options
  • switching to another treatment will also take time to arrange (costs as well)
    • purchasing another PAP unit out of pocket; this is not feasible for everyone and the supply of such PAP units may become limited.
    • contact your insurance provider and DME company to discuss your options and coverage

IF YOU ARE USING OXYGEN WITH YOUR PAP UNIT, CONTINUE TO DO SO EVEN IF YOU STOP THE PAP TREATMENT

As always, you can reach out to your provider and we will do our best to get back to you in a timely manner. This is an evolving situation and our guidance may change as more information becomes available. We will do our best to keep you informed as we obtain this information.

*PLEASE CHECK BACK ON THIS SITE FOR UPDATES AS AVAILABLE
*FOLLOW INFORMATION UPDATES ON THE RESPIRONICS WEBSITE
(www.respironics.com) see banner at the top of the page for recall information