Shaping Policy for Better Patient Outcomes.
Philips Respironics Recall
The Food and Drug (FDA) recalled several Philips Respironics products over safety concerns on June 14, 2021. This recall is considered one of the most serious recall in recent times and its impact is expected to last for several years.
Concise summary of key points related to the Philips Respironics PAP recall
Information to empower those affected by recall to advocate for policies prioritizing patient safety and care
Report serves as a call to action for changes related to medical device regulation and patient safety
This work is supported by a grant by the American Academy of Sleep Medicine Foundation. Any opinions, findings, and conclusions or recommendations expressed in the above publications are those of ASAP and do not necessarily reflect the views of the American Academy of Sleep Medicine Foundation.
​Philips Recall Information
A safety message about a recall of certain Philips Respironics CPAP/respiratory devices. We understand this news is concerning. Devices from other companies have not been recalled. If you do not use a Philips Respironics CPAP/respiratory device, you do not need to read this message.
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Philips Respironics has recalled certain CPAPs, BiLevel CPAPs, and ventilators. Some of the devices that are recalled are pictured here:
What is the health risk?
The foam in these devices may break into smaller pieces that can be swallowed or breathed in. Also, it may give off harmful gases. This can cause headache, cough, chest pressure, and sinus infections. These symptoms have been reported very rarely in one out of every 3000 device users.
How do I check if my machine is affected?
To check to see if your device is affected by this recall, you can:
Visit the Philips website for a list of affected devices
Call Philips at (877) 907-7508 (Spanish language available)
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​Call the company that gave you your machine. Their phone number is usually listed on a sticker on the device.
Should I Stop Using My Machine Or Call My Doctor?
You should call your doctor’s office if your device is recalled and:
You are having symptoms of headache, cough, chest pressure, sinus infection
You see black pieces in the hoses of your machine
Your risk is low if you do not have symptoms or see black pieces in your machine. It may be better to continue to use the device rather than stop it for some patients. For example, if you have severe sleep apnea or daytime sleepiness because of sleep apnea.
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If you are concerned about using your device, call your doctor’s office. Together with your doctor you may decide to:
Continue using your device while waiting for a replacement
Stop using your device while waiting for a replacement
​Get another device immediately
Change to another type of treatment
How Do I Get A New Device?
You can get a replacement device from Philips by calling (877) 907-7508 or you can register online. You may also be able to get a replacement if your device is more than five years old. You can find out by calling the home care company that gave you your machine. If you need another device immediately, your doctor can provide an order for one. If you have questions about the cost of a new device, check with your insurance company.
What if I decide to keep using my device?
Watch for symptoms or for black pieces in the hoses of your machine. If you start to have symptoms or see black pieces, call your doctor’s office.
Stop using any cleaning devices to clean your equipment. Ozone cleaning devices (such as the SoClean device) may increase foam breakdown. You can see the instruction manual for the device or website for cleaning instructions.
At any time, if you are not sure what to do, please contact the office of the doctor who gave you the device.