On June 14, 2021, Philips Respironics voluntarily recalled some of their sleep apnea and ventilator devices because of potential health risks. It is reported that the foam used to reduce noise and vibration might break down and become harmful if inhaled. Philips reported consumer complaints of headache, cough, chest pressure, and sinus infection from people using these recalled devices. Based on the reports Philips has received the known risk of harm from the Philips devices appears to be low. 

To review a list of the affected sleep apnea and ventilator models, please contact Philips's recall support hotline at 1-877-907-7508 or visit the website below.

If you have an affected device, please take the following steps:

  1. Register your device with Philips. Visit the Philips Respironics site or call Philips at 1-877-907-7508. Once registered, you can visit the Philips Patient Portal and will receive updates from Philips on their repair and replacement process.
  2. Do not discard your Philips device. You will need to exchange the device you have when a replacement becomes available.
  3. Do not use ozone products (e.g., SoClean) to clean your device. Ozone might break down the foam and could be harmful if inhaled.
  4. Stay informed. We will maintain information about the recall and repair, and replacement process online here. We also suggest checking the Philips website (see above) for updates.

This is an international recall, therefore, replacing or repairing your device may take time. Emory Healthcare takes this recall seriously and is working with all parties involved to resolve this issue as quickly as possible. 

 

Receiving Your Replacement Device

Many patients have begun receiving their devices and have questions on the new DreamStation 2 device. Philips has developed the website link below that provides instructions in clear, concise and easy to understand form. Please use the link below to access information on the breakdown of your recalled device, setup of the new equipment, how to return the recalled device, etc.

Frequently Asked Questions About the Continued Use of Philips Respironics Devices

Q. Am I at risk for a serious medical complication if I continue to use my Philips device?

A. Based on the reports Philips has received to date, the known risk of harm from the Philips devices appears to be low. Of the consumer complaints that Philips receives for its millions of devices, the company reported that 0.03% of complaints received in 2020 related to the medical complications in this recall. Please review the recall information and FAQs on Philips’s website to understand the risks involved in continuing use.


Q. If I continue to use my Phillips device, do I need to let my doctor know?

A. Yes. Please send your physician a message through the patient portal, update them during your next medical appointment, or call 404-712-7533.

Q. Are there other steps I should take if I continue to use my device?

A. Yes. Until Philips has provided a replacement device or repair, please continue to order your CPAP supplies according to the schedule provided by your CPAP supplier.

Q. Should I use ozone cleaning products?

A. No, Phillips recommends not using ozone products to clean your device. Ozone might break down the foam used to make the device run more quietly, and could be harmful if inhaled.  Philips recommends you follow your device’s Instructions for Use for approved cleaning methods.

Q. Why did Philips Respironics announce a voluntary recall on continuous and non-continuous ventilators?

A. Philips has recalled some breathing devices and ventilators because it received reports that the foam materials in its devices used for sound reduction might degrade and become toxic, potentially causing cancer. When the foam degrades, it could be ingested or inhaled by the user. The foam materials could also off-gas certain chemicals, especially when cleaned using unapproved methods such as ozone.

Q. Which Philips Respironics devices are included in the voluntary recall?

A. A list of devices included in the recall is available on the Philips’s website below.

Q. What is Phillips going to do about this?

A. Philips is notifying customers and users of affected devices. Affected devices will be either replaced with a new or refurbished unit that incorporates the new sound abatement foam material or repaired to replace the sound abatement foam. The new sound abatement foam material will also be used in future devices.

Q. Can I talk to my doctor about the recall and next steps?

A. If you still have questions for your doctor that have not been addressed in the frequently asked questions above, please contact our office through patient portal or by calling 404-712-7533.

Philips has released a statement regarding their mask systems that contain magnetic clips. Please click the link below to review.