In the United States, the Food and Drug Administration (FDA) regulates various medical devices to make sure they are safe, including continuous positive airway pressure (CPAP) machines and bilevel positive airway pressure (BiPAP) machines. Companies that make medical devices monitor for problems with their devices and report any that arise to the FDA.
If a device is not working correctly or could cause health problems, the company may voluntarily recall it or the FDA may issue a recall. A recall may mean that a device needs to be checked that it works properly, requires a repair, or that people should stop using it.
We provide a list of currently recalled ventilators, CPAP, and BiPAP machines and discuss reasons behind the current Philips CPAP recalls, the potential health risks, and what your next steps might be if you own a recalled CPAP machine.
Currently Recalled Machines
As of July 2024, the machines currently recalled in the U.S. made by Philips Respironics between 2009 and 2021 include:
- A-Series BiPAP A30
- A-Series BiPAP A30 Hybrid
- A-Series BiPAP A40
- A-Series BiPAP V30 Auto
- C-Series ASV
- C-Series S/T
- C-Series System One BiPAP
- DreamStation ASV
- DreamStation AVAPS
- DreamStation BiPAP
- DreamStation CPAP
- DreamStation GO CPAP
- DreamStation S/T
- Dorma 400
- Dorma 500
- E30
- Garbin Plus, Aeris, LifeVent
- OmniLab Advanced+
- RemStar SE Auto
- System One ASV4
- System One BiPAP autoSV
- System One 50 Series
- System One 60 Series
- Trilogy 100
- Trilogy 200
Not all Philips Respironics CPAP machines and supplies are currently recalled. If you are unsure whether your CPAP machine is recalled, read the FDA’s information on how to tell if your device has been recalled or ask your doctor or your medical equipment supplier to check for you.
Philips Voluntary Recall
The initial June 2021 recall was prompted by health concerns related to the polyester-based polyurethane (PE-PUR) foam used in these machines to dampen sounds and vibrations. This foam can break down over time due to high temperatures or humidity or due to certain cleaners. People using these machines could breathe in or swallow small pieces of the broken-down foam or harmful chemicals released by the foam.
In February 2023, Philips issued another recall for certain DreamStation Auto CPAP machines that were repaired after the June 2021 recall. Errors in programming could cause some DreamStation Auto CPAP machines to give the wrong CPAP therapy or to not work at all, which could lead to a serious health condition or injury.
In September 2023, Philips agreed to pay $479 million in damages to users for the costs incurred purchasing recalled devices. However, Philips is facing a separate class-action lawsuit with thousands of plaintiffs claiming injury and wrongful death.
A ProPublica investigation in September 2023 found that Philips failed to act on evidence that its devices were harming users for over a decade. This led to calls for the immediate action and intervention of the Department of Justice (DOJ).
As of April 2024, Philips reached an agreement with the DOJ to stop selling CPAP machines and respiratory devices in the United States. The company’s production line is required to undergo regular inspections for the next five years and turn over part of its revenue to the federal government. The company may continue to sell machines considered medically necessary by the FDA and is required to provide refunds or replacement devices to customers affected by the recall.
Health Risks of Recalled Machines
CPAP therapy has some common side effects, but none of these are usually serious. However, Philips recalled their CPAP machines due to several potential health risks. Inhaling or swallowing chemicals or broken-down bits of PE-PUR foam may lead to:
- Coughing
- Asthma
- Skin, eye, nose, or throat irritation
- Headache
- Dizziness
- Nausea
- Vomiting
- Allergic reactions
- Harmful effects to organs like the liver or kidneys
There is also a concern that breathing in or swallowing PE-PUR foam or chemicals may raise risks of cancer, but there isn’t enough evidence yet to show whether this is the case. A CPAP machine set to deliver the wrong therapy or no therapy could result in worsening or a return of sleep apnea symptoms or serious complications such as pulmonary hypertension or heart failure.
What to Do if Your CPAP Machine Is Recalled
Talk to your doctor as soon as possible if your CPAP machine is on the CPAP recall list. Your doctor may advise you either to stop using your CPAP machine or keep using it until it can be repaired or replaced with a new one. Alternatively, your doctor may recommend that you switch to a different device or treatment. If you have a recalled DreamStation Auto CPAP, then your doctor may be able to reset the CPAP pressure.
How to Repair or Replace a Machine
If your doctor recommends that you get your CPAP machine repaired or replaced, first locate your machine’s serial number by following the directions on the Philips website. You will need this number to verify that it has been recalled and to register it for a replacement or repair.
Register your recalled CPAP machine with Philips Respironics. The registration page will show a confirmation number after you send your registration. Save your confirmation and serial numbers in case you need to contact Philips in the future.
Do not try to remove the foam yourself. This could damage the machine or break off more pieces of foam. In addition, do not use ozone or ultraviolet (UV) light to clean your CPAP machine. These cleaners may worsen breakdown of PE-PUR foam.
References
About The Author
Staff Writer, Sleep Health
Afy is a writer and creative strategist in San Francisco with a master’s degree in international health policy from the London School of Economics. She has written for VeryWell Health, BlackDoctor.org, and Paste magazine and edited peer-reviewed journal manuscripts for Elsevier. Afy says her work with The Sleep Doctor is anything but “sleepy.” She enjoys the opportunity to learn new information and share knowledge that gives people the power to make better choices. Afy also likes to read non-fiction, do creative writing, and travel solo.
- POSITION: Side Sleeper
- TEMPERATURE: Hot Sleeper
- CHRONOTYPE: Bear
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