On June 14, 2021, Philips Respironics voluntarily recalled certain Sleep and Respiratory Care devices due to potential safety issues. Specifically, Philips advised the public of potential health risks related to sound abatement foam that is used in some models of Philips Continuous Positive Airway Pressure (CPAP), BiLevel Positive Airway Pressure (BiLevel PAP) devices, and Mechanical Ventilators.
Philips has established an online support center that allows patients, users, or caregivers to look up their device serial number and begin a claim if their unit is affected. You can review the complete list of the affected devices, along with additional instructions and more information about the recall at: philips.com/src-update.
What you need to do:
- For patients using affected Philips BiLevel PAP and CPAP devices:
Philips recommends that you discontinue use of your device and work with your physician to determine the most appropriate options for continued treatment. Your physician will help you determine if the benefit of continuing therapy with your current device outweighs the risks identified in the recall.
- For patients using affected Philips life-sustaining mechanical ventilator devices:
Do not stop or alter your prescribed therapy until you have talked to your physician. Philips recognizes that alternate ventilator options may not exist or may be severely limited for patients who require a ventilator for life-sustaining therapy, and that therapy disruption is unacceptable. The benefit of continued usage of these ventilator devices may outweigh the risks identified in the recall.
Philips has assured us that resolving this matter is their top priority, and T.J. Samson Home Care will advocate on behalf of our patients to ensure that the issue is corrected as efficiently as possible. We sincerely appreciate your patience and understanding, and we welcome you to contact us with questions or concerns.
Why are the Philips Respironics CPAP and BiPAP devices being recalled?
The manufacturer has identified a problem with a breakdown of the foam material used for sound reduction in their CPAP and BiPAP devices. Very small particles from the foam could break lose and come through the air hose.
What should I do if I use Philips Respironics CPAP or BiPAP device?
If you are a patient that uses a Philips Respironics CPAP or BiPAP device. You should register your device at https://www.philipssrcupdate.expertinquiry.com or call 877-907-7508. Philips Respironics will either repair or replace your device. This may take several months.
If these devices are being recalled, why should I still use mine?
While there is a potential risk from the deterioration of the sound reduction foam, those risks have to be balanced against the known
health risks of untreated sleep apnea. If you are concerned about using your current device, you should weigh the benefits versus the risk.
When I registered on Philips site, they asked if I used an ozone sanitizer. Is that because I voided the warranty by using the cleaning device?
Response from Philips Respironics: "Our testing has shown that the use of ozone can accelerate the breakdown of the foam. We are looking to use the answer to that question as a means of prioritizing devices in the recall. It has no bearing on the warranty."
How should I clean my CPAP or BiPAP device?
Only clean your device according to the manufacturer’s recommendations. Using ozone or ultraviolet light cleaners may contribute to breakdown of the sound reduction foam.
Does this issue affect all CPAP/ BiPAP machines?
No. This impacts only Philips Respironics CPAP and BiLevel PAP devices manufactured prior to April 26, 2021.
How long will it take to address all affected devices?
Considering over four million units affected, we expect it will be a lengthy process.
Are affected devices being replaced or repaired?
Some devices will be replaced, while others will be repaired. Philips hasn't released details yet. We expect the recently purchased CPAP machines will be replaced DreamStation 2. Older machines and BiPAPs will be repaired (because no DreamStation 2 BiPAP in the US market yet).
Will Philips provide a backup machine while my machine is being serviced?
If my machine is to be replaced, will Philips ship the new machine to me first?
Philips has no policy yet (as of 7/14/2021).
What should I do if I continue to use my device?
Watch your humidifier and hose for tiny black particles. This is pieces of the foam that is deteriorating. If you see the particles stop using immediately and call your home care company where your machine came from.
What are other treatment options for sleep apnea?
• Weight Loss
• Positional Therapy (side sleeping)
• Mouthpiece or Oral device
• Surgery (only if you are a candidate)
• Another Brand of CPAP \BiPAP Device
Is additional information available on the Philips Respironics device recall?
More information is available at http://www.philips.com/src-update and https://www.tjregionalhealth.org/services/sleepwell/.