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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.

Shaping Policy for Better Patient Outcomes.
ASAP's report examines the far-reaching consequences of the Food and Drug Administration’s 2021 recall of Philips Respironics CPAP, BiPAP, and ventilator devices. 
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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.

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) 

Call the company that gave you your machine. Their phone number is usually listed on a sticker on the device.

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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.

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.

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Disclaimer: The contents including text, graphics, links, company or industry product information and other materials included on this website are intended for educational purposes only. The content is not intended to substitute for professional medical advice, diagnosis, or treatment. Always seek the advice of your healthcare provider with any questions you may have regarding your medical condition. Never disregard professional medical advice or delay in seeking it because of something you have read in a public group(s). Any mention of products or services is not meant as an endorsement, or recommendation of the products, services, or companies. Reliance on any information provided is solely at your own risk. Please discuss any options with your healthcare provider.

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