Philips Respironics CPAP Machine Recalls
Several Philips Respironics machines commonly used for sleep apnea treatment have been recalled on June 2021 due to potential health risks. Users of these machines could potentially be exposed to toxic chemicals and carcinogens through a foam that’s used in the affected devices as part of nightly sleep apnea treatment.
This foam, also known as PE-PUR (polyester-based polyurethane sound abatement foam), is typically used to reduce sound and vibration that the CPAP machines may cause. That sounds nice except the FDA reports that this foam “may break down… and potentially end up being inhaled or swallowed by the users”, per the Food and Drug Administration safety statement on June 30th, 2021.
Then just some weeks later, July 2021, the FDA issued an official Class I recall for several Philips CPAP, Philips BiPap, and various other Philip sleep machines which we will list below.
Why CPAP Machines have a Class I Recall
The issue with the Philips machines is that the foam meant to lower sound levels the machines can create are prone to degrading and breaking down which could contaminate the machine’s air pathway with particles and chemical emissions that are released as part of that degradation process.
Many users report seeing black debris and specks in their machine which they are then unknowingly inhaling and swallowing inside their bodies. Some of the healthcare issues which we will get into can lead to serious injury, permanent damage, and can be even be life-threatening in some cases.
A Class I recall is the most urgent recall type, typically indicating that the use of a certain product or machine may lead to significant injuries and/or death. If this is such a concern, then a likely question that arises is: Why use this foam?
Well, those who are familiar with this type of medical device understand that BiPAP machines and CPAP machines (continuous positive airway pressure) can be very uncomfortable equipment to use, especially when the user is a light sleeper or needs as little sound as possible before falling and staying asleep.
Now, a big update came in September 2021 when Philips Respironics announced at the beginning of the month, that they “intend to complete their repair and replacement program within 12 months.” Let’s dive into what this could mean for patients and the replacement devices.
Potential Carcinogenic Effects from Recalled Philips CPAP Machines, BiLevel PAP, and Degraded Foam
Along with the Philips recall notification, the FDA also shared reported symptoms and the potential unintentional side effects for patients using these BiLevel PAP (bi-level positive airway pressure) machines and CPAP devices in the FDA’s safety communication. Common symptoms can include:
- Sinus infection
- Skin Irritation
- Eye irritation
- Nasal irritation
- Respiratory tract irritation
- Carcinogenic effects to the kidneys, liver, and other organs
More serious diseases linked to defective Philips CPAP devices may include
- Lung damage and/or Lung Cancer
- Serious respiratory complications including respiratory failure, asthma, and pneumonia
- Colon Cancer
- Kidney Cancer
- Liver Cancer
- Risk of Stroke
What causes foam degradation?
- High heat storage
- High humidity storage
- Improper cleaning methods of the CPAP and/or mechanical ventilator device
- Incorrect cleaning products
How many Philips CPAP Machines are Affected by Recall?
To put things in perspective, there are approximately 4 million Philips machines that use this PE-PUR foam we’ve been discussing. Another shocking statistic that many Americans may not know is that Phillips Respironics is estimated to hold approximately two-thirds (about 65%) of the CPAP industry and market.
These news are absolutely devastating to approximately two million Americans who may now find themselves being forced to switch their sleep apnea treatment in order to avoid serious injury.
And if that doesn’t get your attention, consider this: in Fiscal Year 2020, the VA’s Annual Benefit Report shows that 403,483 American veterans have service connected sleep apnea! Think about the ones who are still fighting to get their sleep apnea service connected for benefits.
Another terrifying statistic to consider is that the VA has issued an estimated 600,000 or so of these Philips CPAP machines and Philips BiPAP Machines to our nation’s veterans for home use. As VA disability attorneys, we speak to veterans with sleep apnea every single day. This is a very pressing issue that is extremely prevalent among veterans. Below, we’ll address the official list of affected devices from the Philips statement.
What Philips Machines for Sleep Apnea are part of the voluntary recall?
Philips.com has a complete list of affected and not-affected sleep medicine devices. Below we will list them off for your convenience. Now please keep in mind that you should always consult with your medical care provider before taking any immediate action on your respiratory care. The FDA also recommends writing down your device’s serial number for future reference and signing up on the Philips recall notice website for the latest updates on replacement devices and repairs.
Philips Continuous Mechanical Ventilators Recalled
- Trilogy 100 Ventilator
- Trilogy 200 Ventilator
- Garbin Plus, Aeris, LifeVent Ventilator (not marketed in US)
- A-Series BiPAP Hybrid A30 (not marketed in US)
- A-Series BiPAP V30 Auto Ventilator
- A-Series BiPAP A40A-Series BiPAP A30
Philips CPAP Machine and BiLevel PAP DreamStation Device Recalls
- E30 (continuous ventilator, minimum ventilatory support, facility use)
- DreamStation ASV
- DreamStation ST, AVAPS
- SystemOne ASV4
- C Series S/T, AVAPS
- OmniLab Advanced Plus
- System One 50 series
- System One 60 series
- DreamStation CPAP, Auto, CPAP, BiPAP
- DreamStation GO CPA, APA, Auto, CPAP
- Dorma 400, 500 CPAP, Auto CPAP
Which Philips CPAP Machines Have NOT Been Recalled or Discontinued?
- Trilogy Evo
- Trilogy Evo OBM
- Trilogy EV300
- Trilogy 202
- A-Series Pro and EFL
- Respironics M-Series REMStar CPAPs, Auto CPAPs, BiPAPs
- DreamStation 2 Auto CPAP Advanced and DreamStation 2 Auto CPAP
- Omnilab and OmniLab Advanced Titration devices
- V60 Ventilator
- V60 Plus Ventilator
- V680 Ventilator
- REMStar SE and Sleep Easy CPAPs
- Dorma 100, Dorma 200 CPAPs (not marketed in US)
- All oxygen concentrators, respiratory drug delivery products, airway clearance products.
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