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Philips Respironics CPAP/BiPAP Recall

Updated March 13, 2022

FDA Frequently Asked Questions about the Philips Recall

Updated August 27, 2021

Patients with sleep apnea currently using a Philips Respironics CPAP/BiPAP device:

On June 14, 2021, Philips Respironics voluntarily issued a recall on some of their CPAP/BiPAP/ASV machines due to concerns for potential health risks. This has to do with potential degradation of a foam used to dampen sound in the devices with risk for inhalation and ingestion of foam particles. The reported potential health risks include headache, irritation, inflammation, respiratory issues, and possible toxic and carcinogenic effects. The complaint rate identified by Philips was 0.03% in 2020.

To review a list of the affected CPAP/BiPAP/ASV models, please scroll down to the bottom of the page.

Philips is working to fix this problem by replacing affected devices. Philips advises patients to stop using these CPAP/BiPAP devices; if patients continue using the devices, they should consult with their medical providers and weigh the risks and benefits.

In some cases, it might be beneficial to consider the continued use of the current CPAP/BiPAP/ASV devices, particularly when severe sleep apnea and/or severe symptoms are present. While waiting for a replacement device, patients should be aware of, and closely monitor for, the potential health risks reported by Philips.

Research into the severity and extent of the risk is still ongoing.

The content of this message and recommendations may change as we get new information.

Philips does not recommend use of bacteria filters on CPAP/BiLevel devices as a means of mitigating risk of PE-PUR foam chemical emission or particulate matter. Philips recommends following manufacturer’s recommendation for cleaning PAP device and discontinuing use of ozone-based PAP cleaning devices such as the SoClean.

Please contact your DME provider and visit the Philips website (www.philips.com/src-update) for updates and call Respironics Recall Support Hotline (877.907.7508) to place a claim on your unit. If you would like to discuss this further, you can call Mary Washington Sleep Medicine at 540.741.7846 to schedule a visit with your doctor.

Neal Maru, MD and Pascal Ngongmon, MD
Mary Washington Sleep Medicine

Affected Devices

All Devices manufactured before 26 April 2021 (DreamStation 2 is not affected)

  • DreamStation ASV
  • DreamStation ST
  • AVAPS
  • SystemOne ASV4
  • C-Series ASV
  • C-Series S/T and AVAPS
  • OmniLab Advanced+
  • SystemOne (Q-Series)
  • DreamStation
  • DreamStation Go
  • Dorma 400
  • Dorma 500
  • REMstar SE Auto
  • E30 (Emergency Use Authorization)

Other Information: If you need any further information or support concerning this issue, please contact the recall support hotline or visit the website: 1-877-907-7508 www.philips.com/src-update

Philips Recall Letter

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