The following is being reported by the US Department of Veteran Affairs
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 approximately 300,000 of these devices to Veterans for home use. An additional 2,000 devices are used within VA in hospital or clinic settings.
VA clinical teams are reviewing patient records to identify those who have received these devices and will work directly with impacted Veterans to repair or replace their equipment.
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. We expect to issue additional guidance in the coming days.
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?
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 Veterans do if they have use Philips Respironics CPAP or BiPAP device?
If you are a Veteran that uses a Philips Respironics CPAP or BiPAP device, continue to use your device as prescribed. You should register your device at https://www.philipssrcupdate.expertinquiry.com. Philips Respironics will send you a new device when one is available. This may take several months. If you are concerned about using your current device, call your care team or send them a secure message through MyHealtheVet to schedule an appointment.
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.
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. VA clinical experts are working with the FDA and the manufacturer to understand those risks. We expect to issue additional guidance in the coming days.
Will my CPAP or BiPAP be replaced?
Each patient’s needs are different, and your care team will determine if a CPAP or BiPAP from a different manufacturer will work for you, if a replacement is available, or if PAP therapy is no longer recommended for you. It is VA’s goal for Veterans who continue with PAP therapy to be provided with a replacement device as soon as possible. VA requests that you register your device through the Philips Respironics Patient Portal at: https://www.philipssrcupdate.expertinquiry.com or call 877-907-7508. Philips Respironics will send you a replacement device. This may take several months.
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 only impact devices purchased by VA?
No. This impacts all Philips Respironics CPAP and BiLevel PAP devices manufactured prior to April 26, 2021.
Is additional information available on the Philips Respironics device recall?