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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’m still a bit confused about this whole process. This is a defective product. Why is Phillips not more responsible? All they have to do here is start a recall and the rest is on the consumer who trusted their products. When my Kia recalled their car for a defective issues, I took it to the dealer and they fixed it for free, no cost to the consumer, why is Phillips any different? Why should it matter how long I have owned my machine, they have a defect, that’s not warranty, that’s defect on them. They should be held accountable.
I’m still a bit confused about this whole process. This is a defective product. Why is Phillips not more responsible? All they have to do here is start a recall and the rest is on the consumer who trusted their products. When my Kia recalled their car for a defective issues, I took it to the dealer and they fixed it for free, no cost to the consumer, why is Phillips and different? Why should it matter how long I have owned my machine, they have a defect, that’s not warranty, that’s defect on them. They should be held accountable.
Never could use mine for long because it made me sick. My son recently started using one and has similar problems with no diagnosis because no one knows what is wrong.
I am one of the poor sucks that bought one of these machines, I am just getting over(hopefully) a sinus infection that I had to get a ct scan to discover, two weeks of antibiotic and nasal steroid sprays; then find out this recall and wondered if the chest pains i have been having is related to the use of this machine., So my doctor sent me to get a chest X-ray. so much radiation in the last month just to make sure I wasn’t slowly being killed by the machine that was supposed to keep me healthy. The cost of these machines and the R&D to make these, someone over there best be getting fired over this. Never again philips.
I have been using a Phillips Dreamstation for 5 years. Since using it doctors have been trying to figure out why I’m constantly congested. I’ve had several allergy tests, asthma test, etc. and they can’t figure it out. I now wonder if this CPAP machine is the issue. I can’t believe that a well respected company like Phillips would have chosen to put foam made of materials that could cause respiratory and cancer into a machine made for helping with breathing. This is beyond me.
Because it has been 5 years, I’m now eligible to have insurance help with purchasing a new CPAP. I’ll avoid Phillips.
Now, I have grave concerns. I started using the C-Pap I believe in 2013. Since then I have been diagnosed with inflammation of the brain, my lungs have gotten steadily worse over time with no explanation or diagnosis, I have full body inflammation with no definitive diagnosis altho some are floating around so the providers can get paid, but no one has revealed to me when I inquire what type of autoimmune I have. I am high risk without the C-Pap machine and this is a pass the buck type of situation. The company advises us to consult our physicians. My neurologist yesterday would not advise and told me it was up to me. Seriously? He did admit I was high risk. How much of that stuff have I inhaled over the years and how much of this is contributing to the (unexplained to me) inflammation in my body? Further, I received a phone message after my visit from my neurologist saying I must be careful. If I suspect any type of infection going on in my respiratory system I ( get this) should move the machine to another room to use since particles are aerosolized into the air of the room.
I was having vfib and found out through a sleep study last year that I have moderate to severe sleep apnea. The philips dreamstation has helped me so so much and i can’t believe we are being told not to use it – without a resolution for the existing machine. I am going to continue to use my cpap as the potential for vfib is a greater health risk than cancer I suppose??!! unbelievable that they would manufacture a product that has malfunctioned in this way. I want to be part of a class action for this recall.
Got my Philips Remstar Auto A-Flex 5 years ago. Two years later starting having coughing fits. After long wait to get into a Respirologist she sent me for a CT scan (oh boy radiation and a 1 in 400 chance of getting lung cancer as a result of the scan) – diagnosis, sensitive lungs and mild asthma. By then it has been 3 years since I started the machine. Prescribed steroid inhaler (expensive) twice a day for rest of my life. Last two years (year 4 & 5 of machine use) despite the steroids it has been getting progressively worse – phlegm all the time, can hear it in my voice. This recall would explain it all – thanks Philips.
Plus (had to ad) they say “Stop using it right away!”… great and do what, fork over $1000 for a new machine to use while Philips gets some sort of replacement going? IF you can find one – because this has put huge demand on the CPAP sellers of other brands… stock is way down. Really not happy about this.
PS there are youtube videos on how to take out the foam so you can keep using your machine… people say not much nosier. Don’t know how continued use would affect any law suit… save the foam for sure if you do it and maybe video the process so you can prove it came out of your machine. Or lay it safe and get another machine if you can afford it.
None of what I said above should be considered advice of any sort.
How freaking great!Like I don’t have enough to worry about in this evil and corrupt world we live in,I’ve just been told I’ve been sucking cancer causing and God knows what else moon dust for the last ten or so years.It’s no wonder I can’t breathe.I dunno how many times I’ve had sinus infections,sneezing,swelled red eyes,nose burning,bad headaches,and that god awful taste.I have swore to my wife it was the cpap doing it,and she would say I was crazy.Well she’s a believer now and is just as pissed as I am.There’s no making this right.I will be seeking an attorney ASAP!!!
Please let me know what the attorney says. I’m 59, and been using this machine for 4 yrs now. And the last couple of now. Having blood issues, that cancer and blood disorder Dr. can’t figure out what’s going on. Now I have to have a blood transfusion, monthly. Please let me know what you find out. God Bless
Seriously upset! My sleep apnea device is in the recall. How dare them allow for this machine to be so widely used!!! Now I am concerned that my headaches and lung problems and possibly my lipomas are caused by this machine!!!!
Where is the FDA and other regulatory agencies in this approval of these machines. You are talking about possibly creating cancer in many people who need oxygen due to health problems. Particulates of plastic or foam or whatever it is going into my lungs and other places is completely unacceptable. My email is not to be used to attempting to get me to buy some other sleep apnea device! I am going to go off it and breath on my own. Regardless of whether I have severe sleep apnea not breathing is better than breathing degrading substances!
I’ve been using my cpap almost a year now
And have noted pain in the center of my chest for several months now
Atearing almost ripping sensation that especially is painful when I cough or worse sneeze
I believe philips could have recalled these hazardous devices long ago but chose to only go public after their release of their sleep station 2