VHA National Center for Patient Safety
Philips CPAP and BiLevel PAP Recall
Philips Respironics announced a voluntary recall for certain CPAP, BiLevel PAP, and mechanical Ventilator Devices due to issues related to deterioration of the sound abatement foam used in these devices. This recall affects CPAP and BiLevel PAP devices manufactured prior to April 26, 2021. VA has distributed nearly 600,000 of these devices to Veterans for home use. An additional 2,000 devices are used within VA in hospital or clinic settings.
Please watch the video below from fellow Veteran and CPAP user, Acting Executive Director of VHA’s National Center for Patient Safety, Dr. Edward Yackel, to learn about how VA is addressing the recall and supporting Veterans who have Philips Respironics CPAP/BiPAP devices.
VA is sending notifications to Veterans who have been provided a Philips Respironics device to inform them of the recall. Anyone with a recalled device is urged to register with Philips Respironics on their website or call 877-907-7508. Philips will provide a replacement device when they are available and instructions on returning your current device. Because of a worldwide shortage, Philips Respironics has acknowledged that this may take up to a year.
While there is a potential risk from the deterioration of the sound abatement foam, those risks have to be balanced against the known health risks of untreated sleep apnea. VA clinical experts are working with the FDA and the manufacturer to understand those risks. Additional information on the recall and potential health effects can be found here.
Veterans with questions can send a secure message to their care team through MyHealtheVet.
Frequently Asked Questions
Why are the Philips Respironics CPAP and BiPAP devices being recalled?
Phillips Respironics 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 Veterans do if they have use Philips Respironics CPAP or BiPAP device?
If you use a Philips Respironics CPAP or BiPAP device, continue using your device as prescribed. Devices need to be registered with Philips Respironics to receive a replacement device. You can register your device at https://www.philipssrcupdate.expertinquiry.com or call their registration line at 877-907-7508. If you have symptoms or concerns related to your device, please call your care team or send a secure message through MyHealtheVet to schedule an appointment.
How will I receive a replacement device?
For Veterans who receive their health care from the VA, your replacement device will be sent from Philips Respironics to the VA so your prescribed settings can be set before you receive the device. Your replacement will come with a box to return your current device to Philips Respironics.
Veterans who receive their health care outside of the VA health care system will receive their new device directly from Philips Respironics. You may have to contact your care provider to program the device to your prescribed settings. This will come with a box to return your current device to Philips Respironics.
What are the health risks if I continue to use my device?
To date, Philips Respironics has received several complaints regarding the presence of black debris/particles within the airpath circuit (extending from the device outlet, humidifier, tubing, and mask).
At this time no serious adverse health events have been reported but Philips Respironics has received reports of headache, upper airway irritation, cough, chest pressure and sinus infection. Other potential risks identified by Philips Respironics from degraded foam exposure include: Skin, eye and respiratory irritation, headache, asthma, adverse effects to other organs (e.g. kidneys and liver) and carcinogenic effects. The full report is available here.
What devices are more likely to have a problem with the foam breakdown?
Philips Respironics states that the likelihood of foam breakdown is higher in devices that are more than three years old, are used in high heat (more than 95 degrees) and high humidity environments or that were routinely cleaned with an ozone cleaning device. Age is also a factor and Philips Respironics recommends replacing machines that are more than five years old. The full report is available here.
Philips Respironics announced that chemicals could be released when the foam breaks down. What are the risks?
According to Philips Respironics, as the foam breaks down gasses are emitted for about eight-hours of use. They are undetectable after 24 hours of use. The full report is available here.
Can I just remove the foam from the device?
No. The foam cannot be removed without damaging the device.
If I stop using my CPAP or BiPAP device will my disability benefits be impacted?
No. If you and your care team decide to pause the use of your CPAP or BiPAP your disability benefits will not be impacted
If these devices are being recalled, why should I still use mine?
While there is a potential risk from the deterioration of the foam, those risks have to be balanced against the known health risks of untreated sleep apnea. VA clinical experts are working with the FDA and the manufacturer to understand those risks. We are aware that Philips Respironics said to stop using your CPAP or BiPAP device. The VA follows the guidance of the American Academy of Sleep Medicine and American Thoracic Society which advise patients to continue using the device and consult their care provider regarding continuing or pausing use.
Does this recall impact VHA sleep clinics?
Due to the volume of units affected, VHA sleep clinics may need to alter day-to-day operations as they support Veterans impacted by the recall.
When I registered on the Philips Respironics site, why did they ask if I used an ozone sanitizer? If I used an ozone sanitizer will it impact my warranty?
Response from Philips Respironics: "Our testing has shown that the use of ozone cleaners can accelerate the breakdown of the foam. The more we know about these devices the more research we can do. 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 recall only impact devices purchased by VA?
No. This impacts Philips Respironics CPAP and BiPAP devices sold worldwide prior to April 26, 2021.
Is additional information available on the Philips Respironics device recall?
More information is available at http://www.philips.com/src-update.