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Philips is recalling millions of its CPAP machines, ventilators, and other breathing devices – many used for sleep apnea – due to potential risks of chemical exposure posed by noise-reducing foam in the devices made from polyester-based polyurethane.
Between three and four million of the Bi-Level Positive Airway Pressure (Bi-Level PAP), Continuous Positive Airway Pressure (CPAP), and mechanical ventilator devices are being recalled.
The company has not received any reports of death connected to the sound abatement foam or any reports of impact from chemical emissions, but it has received reports of possible patient impact due to foam degradation, it says in the recall notice.
“The potential risks of particulate exposure include headache, irritation, inflammation, respiratory issues, and possible toxic and carcinogenic effects. The potential risks of chemical exposure due to off-gassing include headache, irritation, hypersensitivity, nausea/vomiting, and possible toxic and carcinogenic effects.”
Despite a low complaint rate (0.03 percent in 2020), testing by the company determined that there were possible risks to users related to this type of foam, including that it might degrade into particles. Philips says in the notice that those particles may enter the device’s air pathway and be ingested or inhaled by the user, and the foam may off-gas certain chemicals.
“The foam degradation may be exacerbated by use of unapproved cleaning methods, such as ozone, and high heat and high humidity environments may also contribute to foam degradation,” the company says.
Frans van Houten, CEO of Royal Philips said the company deeply regrets any concern and inconvenience caused to patients using the affected devices.
“In consultation with the relevant regulatory agencies and in close collaboration with our customers and partners, we are working hard towards a resolution, which includes the deployment of the updated instructions for use and a comprehensive repair and replacement program for the affected devices. Patient safety is at the heart of everything we do at Philips.”
The company is urging patients using BiLevel PAP and CPAP devices to discontinue use and to work with their physician to determine the most appropriate options for continued treatment.
Philips says that patients using life-sustaining mechanical ventilator devices should not stop or alter their prescribed therapy until they have talked to their physician.
“Philips recognizes that alternate ventilator options for therapy may not exist or may be severely limited for patients who require a ventilator for life-sustaining therapy, or in cases where therapy disruption is unacceptable,” the company says in the recall notice.
“In these situations, and at the discretion of the treating clinical team, the benefit of continued usage of these ventilator devices may outweigh the risks identified in the recall notification.”
Philips says that it will replace the current sound abatement foam with a new material and has already begun the preparations, which include getting the relevant regulatory clearances. It says that it aims to address all affected devices in scope of this correction as expeditiously as possible.
“As part of the program, the first-generation DreamStation product families will be modified with a different sound abatement foam and shipped upon receipt of the required regulatory clearances. Philips’ recently launched next-generation CPAP platform, DreamStation 2, is not affected by the issue.”
To support the program, Philips is increasing the production of its DreamStation 2 CPAP devices that are available in the US and selected countries in Europe.
For more information on the recall notification, as well as instructions for customers, users and physicians, affected parties may contact their local Philips representative or visit www.philips.com/SRC-updateExternal Link Disclaimer.
Have you used a breathing device manufactured by Philips? How do you feel about this recall? Let us know in the comments section or join a CPAP class action lawsuit investigation!
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117 thoughts onRecall Check: Philips Recalls Millions of CPAP and Ventilators Over Fears of Chemical Exposure, Carcinogenic Effects
I have tried to put into words how upset I am with this company, Philips, but there is so much to say it is difficult. I cannot sleep without my cpap. And the recall says to stop using it. Really? What am I supposed to do? The company I bought it from says that Philips is not giving any assistance whatsoever. So I am FORCED to continue using the machine that could very well be causing cancer. I am continually sick with respiratory infections and nausea. Now I know where that is coming from. And have you seen how we are supposed to replace the filter? You have to take the entire machine apart and then CUT a hole in the plastic to remove the filter as it is fully encased. And they cannot even tell us when we can expect to receive the filter. I am not one to sue but this will probably need to be addressed in a courtroom.
I’ve been using my Dreamstation cpap machine for over three years. For the past year or so, my asthma has worsened. I chalked it up to the rotten apartment complex I live in with shared vents and neighbors who smoke – contrary to management’s policies – and stress due to the pandemic. When I heard about this recall I was devastated. Philips is telling everyone to stop using these machines but that would be TOO DANGEROUS.
I have palpitations if I fall asleep w/o my cpap on. I MUST have it. Every. Single. Night.
What in God’s name am I supposed to do – pray each night that I don’t die if I stop using my cpap machine? I can’t win! I could die if I stop using it. I could die if I keep using it.
My asthma’s been much worse during the past year, and my COPD too. I’ve had chronic sinus trouble for YEARS and it’s been much worse. Almost every day I’m sick. I’ve never had it this bad.
Philips says we should speak with our medical providers and DME equipment suppliers to see what can be done. Lincare knows NOTHING about how to proceed. And, I paid for this machine out of pocket because I’m not insured. My current PCP wouldn’t know what to do. She’s a nurse practitioner.
I’m a cancer survivor and I can’t tell you how upset I am that I may have it again thanks to Philips. What am I supposed to do? I can’t just run to the nearest doctor and have them run a battery of tests because I’m uninsured!
I don’t want to take part in a class action suit. I want my own attorney. If anyone reading this who is an attorney and wants to speak with me about filing a suit against Philips – it would have to be on a contingency basis because I’m on a fixed income – please email me at diana manwaring AT yahoo dot com.
I have used the Philips cpap machine going on 8 years @ First it was ok . The I started having coughing issues also repeated sinus infections . Dr Would prescribe antibiotics & Sometimes Steroids. Over the years things started getting worse I started having weird ear pressure along with blurry vision upon awakening. I have Afib a Heart condition when not using the cpap. Recently had a Echo & Something has caused my aorta too enlarge in 16 months . When I talked to My Doctor about the recall he basically said coughing could be Asthma ? After all the Cleveland clinic was the 1 who recommend the Cpap test & I’m sure they will make a Killing from everyone who has been Poisoned by these Machines
I have gone from normal liver numbers in 2019 to Cirrhosis of the liver in 2021. I received my new Dreamstation bi-pap machine in December of 2020. These chemicals that have been leaching off these machines affect the liver in many diverse ways. My doctors have been puzzled by the sudden onset and the speed in which I developed Chirrhosis. I have my first biopsy on Friday and will find out then how much time I have left. NO ONE FROM EITHER PHILIPS OR AMERICA’s HEALTHCARE AT HOME notified me that I had a potentially dangerous or lethal machine. NO ONE. I only found out on June 23rd because I had a routine appointment with my sleep doctor and there was a notice on their website. REALLY? If I had not had that appointment I’d have been using the machine until…when? I died? I am astounded. Watch your liver numbers. If there is ANY slight change get your liver checked ASAP. I am convinced that Philips might be involved in my medical issue and will be insisting on getting whatever help I can to determine any culpability on the part of both of these companies.
I have also been feeling utterly terrible. My sinuses are always closed and I have terrible migraines. Whats worde is my blood trat shows high c-reactive protien which is an indicator of inflamation. My doctor is not sure what is causing the inflamation. Now we knkw.
I received my cpap june 2020, October 2020, i started having a chronic cough. I was treated with antibiotics and steroids. This was several times. I was sent to a lung doctor.
I had blood work, breathing test and catscan done. It showed i had inflammation around both lungs.
He sent me to a arthritis dr because he thought i had rheumatoid arthritis.
That doctor said i did not have rheumatoid.
The next visit with my lung dr, he told me about the recall.
After reading the damage the cpap caused, it was how i had been feeling.
My life has suffered due to the inability to live a normal life.
I cough and if i even laugh, the cough spasms are bad.
Any excretion or bending over, causes the cough.
I have missed so much work, i was almost fired.
I need someone to fight for me.
I am on my 3 philips clap machine, the last one being a dream station. When calling my crap clinic, SAS apnea solutions, all they could say is that they would rent me another brand crap machine for $750.00 for 3 months, until this is fixed.. WTF !! My machine is 3 months old !!
Tomorrow I call their head office. Then my lawyer.
I doubt people who do not rely on CPAP heavily to get a decent night’s sleep will appreciate what a serious issue this is. I was so excited to learn last year that I was eligible for an upgrade/replacement of my 10+ year-old machine. The new Phillips DreamScape box was so much quieter! My wife stopped complaining about the noise, I was sleeping better, and I have been using this treatment for many, many years every single night. I can’t sleep without it. Regrettably, however, since I moved to Texas and started using the DreamScape, I started having fits of coughing – much like a smoker’s couch (I quite years ago). Strangely, I also began smelling smoke – as if an ashtray were somewhere in my bedroom or living room. I smelled it when I went to bed and even when I wasn’t wearing the mask for hours after waking up. Finally I see the pieces fitting together. Whatever the hell this foam is, I am 100% certain my coughing and olfactory “illusions” were related. DME has no idea what to do/offer, sleep doctor answering service is non-responsive. Feels like a lot smit is about to hit the fan. If any of my tests in July show any damage, temporary or permanent…. I don’t know what’s going to happen, but we’re supposed to have regulations and safety mechanisms in place to prevent this kind of exposure. Unacceptable, America! Forget about mindfulness, inclusion, and the buzzwords of the day. Let’s get back to accountability, competition, and quality in everything we do! Stop giving trophies for participation and get back to giving awards for perfection and 1st place finishes.
I have complained about issues with my sinuses and headaches and I received little relief for several years. I am told to stop using my machine immediately but I can’t get an appt. at Kaiser until 7/22. This is unacceptable.
It is beyond immoral to tell people to stop using an essential piece of equipment, vital for their health, and offer absolutely nothing in return. My DME says they don’t know anything, PR says it could take months. And what are people supposed to do, just suck it up and wait? Meanwhile, they say we may have all been exposed to something carcinogenic because of their negligence. They can take the loss and get equipment to people. I don’t care how much money they lose, they are obligated to provide a safe and functioning product and they failed. Telling people to wait months is not making it right. I wrote to my Senator and Congressperson.
I agree with you. To sleep without the cpap is life-threatening, and to sleep with it may be, too. Users are between a rock and a hard place. I have been on this machine about four years, and I cough in the morning (not a smoker). Also, sometimes I wake up with it on and smell a burning smell.
Philips needs to make this right, NOW! And some of us may have a class-action suit for sure.