Philips has recalled around 4 million breathing machines because users can breathe tiny particles of toxic cancer-causing foam.
Philips said no one has died yet, but some users have reported suffering from headaches, airway irritation, coughing, chest pressure and sinus infections, according to the Medical Device Recall Notification.
The problem is linked to a type of black foam known as Polyester-Based Polyurethane (PE-PUR), which can disintegrate into tiny particles or toxic gases that users breathe.
Philips designed the breathing machines with this toxic foam inside the same tube that carries the air that a user breathes.
On newer machines, Philips did not change this problematic design. Rather than sealing off the foam from the air a user breathes, the company simply switched out the type of foam in the tube.
Health risks linked to the toxic foam include cancer, organ damage, liver and kidney failure, asthma, sinus infections, and more.
About 80% of the recalled machines are Philips Bi-level Positive Airway Pressure (Bi-level PAP or BiPAP machines) or Continuous Positive Airway Pressure (CPAP machines), which are used to treat obstructive sleep apnea.
The recall includes one of Philips’ most popular products for sleep apnea — the Philips DreamStation CPAP & Bi-Level Therapy System.
The other 20% of the recalled breathing machines are mechanical ventilators, which help patients breathe during surgery or when they cannot breathe due to an illness.
All of the recalled machines contain “sound-abatement” foam that is supposed to reduce noise made by the machine. Over time, the foam in the machine can disintegrate into black particles that a user may breathe.
Testing by Philips also discovered that the foam can “off-gas” toxic chemicals, releasing dangerous Volatile Organic Compounds (VOCs).
The health risks of breathing bits of foam include “irritation to the skin, eye, and respiratory tract, inflammatory response, headache, asthma, and toxic or carcinogenic effects to organs, such as kidneys and liver,” according to the FDA recall notice.
The FDA also warned that health risks of breathing toxic gases from the foam include “headache; dizziness; irritation in the eyes, nose, respiratory tract, and skin; hypersensitivity; nausea/vomiting; and toxic and carcinogenic effects.”
Philips said these risks increase when the foam is exposed to high heat or humidity, or unapproved cleaning methods, such as ozone.
Unfortunately, many patients who rely on Philips’ recalled breathing machines have been left in the lurch.
Philips is asking patients who are using recalled BiPAP and CPAP devices to stop using the deices and talk to a physician to “determine the most appropriate options for continued treatment,” unless the benefits of using the machine outweigh the risks.
For patients who are using life-sustaining mechanical ventilators, Philips said it “recognizes that alternate ventilator options for therapy may not exist or may be severely limited.”
In the meantime, Philips said the company is “working hard towards a resolution,” which will include “a comprehensive repair and replacement program for the affected devices.”
The recall involves the following CPAP and BiPAP machines:
Continuous Ventilator, Minimum Ventilatory Support, Facility Use:
- E30 (Emergency Use Authorization)
Continuous Ventilator, Non-life Supporting:
- DreamStation ASV
- DreamStation ST, AVAPS
- SystemOne ASV4
- OmniLab Advanced Plus In-Lab Titration Device
Non-continuous Ventilator:
- SystemOne (Q series)
- DreamStation CPAP, Auto CPAP, BiPAP
- DreamStation GO APAP, APAP
- Dorma 400, 500 CPAP
- REMStar SE Auto CPAP
Philips also recalled the following mechanical ventilators:
Continuous Ventilator:
- Trilogy 100 Ventilator
- Trilogy 200 Ventilator
- Garbin Plus, Aeris, LifeVent Ventilator
Continuous Ventilator, Minimum Ventilatory Support, Facility Use:
- A-Series BiPAP Hybrid A30 (not marketed in US)
- A-Series BiPAP V30 Auto Ventilator
Continuous Ventilator, Non-life Supporting::
- A-Series BiPAP A40 (not marketed in US)
- A-Series BiPAP A30 (not marketed in US)
How do I get my machine replaced. I have a headach everyday and I have been using it for a year now.
CPAP DreamMachine using So Clean apparatus
I have a system one, what do I need to do?
how do I known if the 2 machines I have are part of the recall
I have a Phillips respironic system one. Is this under recall?
I have 2 Philips CPAP Machines. What should I be doing?
I have 2 Philips CPAP machines.
What should I be doing?
I have been using a Philips Respironics Dreamstation CPAP machine since December, 2017.
The label reads:
DreamStnAutoCPAPHumCell DOM
REF DSX500H11C
a bar code here
SN J17864059AA1F
2016-11-22 REV00
My provider is CPAP Express. The location I was serviced from has been permanently closed, presumablly as a result of the Covid19 pandemic. The last time I was in for service the agent told me I was due for a new machine in December of this year.
I’m wondering if I might just move to a new machine now in consideration of the present recall. Can you give me any information on this?
I’d say for the past year or more I have been having a constant post nasal drip and a feeling of a collection of phlegmn in my trachea at about the level of the bronchia with a sputum discharge upon coughing. I intend to follow this up with an ENT to see if it is related to the possible filter issue with the CPAP machine.
The use of the CPAP has made a tremendously positive difference in my sleep quality and alertness level since I began using it.
Thanks for your help.
Just checking and see if there is a recall on my machine
Thanks for exposing this. Philips’ recall without providing a practical solution (e.g. a replacement machine, or an immediate fix) is simply self-serving. This is a huge problem for many people who, indeed, are being left in the lurch. Shame!
I have a Dream Station Hum Core Pack DOM, (sn- H 234719259BDE) Bi Pap machine. Is my machine one of the ones that were recalled?
I use a continuous positive airway pressure clap device ( E0601-RRKIKX) rental (dme)
1 humidifier, heated used with positive airway pressure device (E0562- RRKX) Rental dme
These devices have both been recalled therefore I want to get a new Cpap device
I have a dream station should I send it back
I have a cpap , how can I fix it and where can I get it fix? Where is the tub that carries the foam? How can I prevent the gases from coming through ? Or what other machines can I get ? What other companies can I get better machine from? Call me now ! or leave a answer. Or I have no choice but to seek legal advice 50million will do for restitution.
The Daily Hornet is an independent news organization, reporting on this issue, not the manufacturer of this product. Currently, the company is “working hard towards a resolution,” which will include “a comprehensive repair and replacement program for the affected devices.” Please contact them for additional information. Thanks for reading the Daily Hornet!
My husband has Philips Capa machine on your recall. He also has Heart Problems….can not control temp on machine. I believe his needs to be replaced because the heat issues with the machine.
He had been on this cpap machine for many yrs. Now❗
I would like some kind of answer
About and when you are replacing machine….He now has a constant cough ❗Will be contacting his Heart Doctor because of this recall
Why didn’t we get notified about your product?
The Daily Hornet is an independent news organization, reporting on this issue, not the manufacturer of this product. Currently, the company is “working hard towards a resolution,” which will include “a comprehensive repair and replacement program for the affected devices.” Please contact them for additional information. Thanks for reading the Daily Hornet!
I need my cpap to help my heart, but I am not using it because of the risks. is there any update on how long I will need to wait to have a replacement. I was having nose bleeds, severe headaches and irritation in the throat. But it is dangerous on both sides.
I have concerns on my health regarding using this CPA machine
Does it include the IP22?
Who do I take my machine to in Adelaide sth . Aust. I live in Grange.
How do I contact and register my machine
Anyone know of any class action pending, if so I’m in. I am angry I was not contacted and it was not even on the news, I found out out reading an obscure online caravan and RV magazine. At least they could have contacted me through my Cpap retailer.
My wife and me each use a Phillips much one, we both have had headaches and other problems but the doc wouldn’t tell us that it’s was because of this machine we still use them cause can’t afford New one’s so how and when would we get some before we get more sickness