Philips Respironics Recall: Cancer and Health Risks from DreamStation CPAP Foam
February 2024 Update: Just two days after Philips officially announced it was halting sales of all its CPAP devices in the United States until 2025 as part of an agreement with the federal government, the U.S. Food and Drug Administration (FDA) released an update on Philips CPAP medical device reports (MDRS), indicating recalled Philips CPAP machines and other breathing assistance devices have been linked to more than 116,000 MDRs and 561 deaths.
September 2023 Update: A $479 million Philips CPAP class action settlement was proposed on September 7, 2023, after the parties submitted a motion to the U.S. District Judge seeking approval of terms to resolve economic loss claims associated with recalled Philips CPAP, BiPAP, and ventilators.
On June 14, 2021, Philips Respironics recalled several million DreamStation CPAP machines, BiPAP machines and ventilators sold since 2009. The Philips CPAP recall results from problems with sound abatement foam inside the machines, which may release black debris or toxic chemicals into the airway.
While the specific side effects caused by Philips CPAP machine foam are still being investigated, there is substantial evidence that breathing these particles and gases increases the risk of cancer, respiratory injuries and other serious health problems.
If you or a loved one experienced problems with a recalled Philips Respironics sleep apnea machine, request a free consultation to see if you qualify for a Philips CPAP lawsuit settlement.
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When was the Philips Dreamstation CPAP recall first issued?
Although the first warnings about foam problems with CPAP machines were disclosed in an investor report in April 2021, the Philips Respironics recall notice was not publicly posted by the manufacturer until weeks later.
An estimated 3.5 million CPAP, BiPAP and ventilator devices were impacted by the recall, each containing a PE-PUR sound abatement foam that is designed to reduce noise and vibrations of the machine. However, the polyester-based polyurethane foam can degrade and release particulate matter and toxic gas into the users’ respiratory airway.
Most of the devices impacted by the Philips Respironics recall are the company’s DreamStation CPAP machines. However, 18 different products sold between 2009 and April 2021 have been recalled.
Which Philips Respironics Machines are being recalled?
A complete list of the recalled Philips Respironics CPAP, BiPap and ventilator machines can be found in an FDA Safety Communication issued on June 30, 2021. Philips Respironics has also released images of the different machines that may contain the defective foam. Check the images below to see if you were using a recalled CPAP machine:
Recalled Philips Respironics CPAP and BiLevel PAP Device Images
Recalled Philips Respironics Mechanical Ventilator Device Images
Images captured from https://www.usa.philips.com/healthcare/e/sleep/communications/src-update
2022 Philips CPAP Recall Updates
Following the 2021 recall involving toxic foam particles in millions of Philips CPAP and ventilator machines, two additional Philips CPAP and BiPAP recalls were issued in 2022.
On August 29, the FDA issued a Philips BiPAP recall impacting several models of ventilators that are equipped with a non-compatible material, which may release volatile organic compounds (VOCs) directly into the machine’s air pathways.The recall includes the following models that were manufactured and distributed for sale throughout the U.S. between August 6, 2020, and September 1, 2021;
- A-Series BiPAP A30 (Ventilator)
- A-Series BiPAP A40 (Ventilator)
- A-Series BiPAP V30 (Auto Ventilator)
- OmniLab Advanced+
Officials warned the plastic in the motor could release toxic VOC’s that have could result in a series of health issues including;
- Irritation in the eyes, nose, respiratory tract (airway), and skin
- Allergic reaction or another immune system reaction
- Nausea or vomiting
- Toxic cancer-causing effects
Just a week later, Philips announced a BiPAP and CPAP mask recall on September 6, 2022, impacting more than 17 million BiPAP and CPAP masks containing magnets that officials warned could interfere with life-saving medical device functionality, such as pacemakers, cardioverter defibrillators and other implantable metallic medical devices.
The Philips BiPAP and CPAP masks impacted in the recall include the devices below;
- Amara View Full Face Mask
- DreamWisp Nasal Mask
- DreamWear Full Face Mask
- Wisp and Wisp Youth Nasal Mask (40lbs or more)
- Therapy Mask 3100 NC/SP (40lbs or more)
As of August 30, 2022, the FDA has received at least 14 Medical Device Reports (MDRs) involving BiPAP and CPAP machine magnetic headgear clips causing serious and potentially life threatening injuries to users, or those with implanted devices nearby. The reports included instances of pacemaker failure leading to pacemaker replacement, a need for shunt adjustment, resetting of automatic implantable cardioverter defibrillators, arrhythmia, cognitive changes, headaches, change in heart rate (tachycardia, bradycardia), convulsions (seizures), and irregular blood pressure.
How do I know if my Philips CPAP has been recalled?
There is no full list of serial numbers impacted by the Philips Respironics recall that has been released. Owners must begin the process of registering their unit with the manufacturer to check whether a Philips CPAP machine has been recalled. That process can be started by clicking here.
Before confirming that the serial number for your sleep apnea machine is included in the recall, it is necessary that you indicate on the first page that you are a “Patient/Device User/Caregiver” and select your country:
After hitting “Next”, you will be asked to enter your Philips CPAP serial number on the second page to check whether your device is recalled.
The serial number for recalled Philips Respironics sleep apnea machines is printed on a label on the bottom of the device, including a series of letters and numbers that follow the “SN” or “S/N” on the label.
It is important to enter the entire serial number without any spaces, and to make sure you use the number printed on the label of the actual machine, and not any attached water reservoir/tank.
What do I do if I am using a recalled Philips Respironics machine?
Immediately after determining if you or a loved one are using a recalled Philips Respironics machine, you should:
- Stop use of BiLevel PAP or CPAP sleep apnea devices, and contact your physician to discuss treatment alternatives;
- Continue to use life-sustaining ventilators, but consult with your physician as soon as possible about the health risks;
In September 2021, a Philips Respironics recall repair and replacement program was announced by the manufacturer. However, it indicates that the process will likely take over a year, leaving owners without the ability to use their CPAP machine.
The Philips Respironics recall lawyers at Saiontz & Kirk, P.A. urge all owners to preserve their sleep apnea machine if they are considering a lawsuit and not return the device to Philips for CPAP repairs or replacements if they are considering a lawsuit. To learn more about the legal options, request a free consultation and claim evaluation.
Philips CPAP Device Refund and Reimbursement Payments
As part of a settlement agreement reached by Philips and the parties of a class action lawsuit in September 2023, the manufacturer is now offering to pay individuals a set amount of money for the return of their recalled CPAP, BiPAP and ventilator devices.
Philips has agreed to pay class members $100 for each recalled device they return, and an additional fixed amount depending on the device. Below is a list of the amounts individuals may be eligible to receive for each specific recalled model.
- System One 50 Series ASV4 (Auto SV4): $469.14
- System One 50 Series Base: $69.14
- System One 50 Series BiPAP: $159.46
- System One 60 Series ASV4 (Auto SV4): $424.32
- System One 60 Series Base: $68.24
- System One 60 Series BiPAP: $152.70
- C-series S/T, AVAPS (C-series and C-series HT): $394.37
- DreamStation CPAP: $55.63
- DreamStation ASV: $379.50
- DreamStation ST, AVAPS: $329.05
- DreamStation BiPAP: $130.63
- DreamStation Go: $107.43
- E30: $453.83
- OmniLab Advanced Plus: $165.99
- Trilogy 100/200, Garbin Plus, Aeris LiveVent: $1,552.25
- V30 auto: $67.12
Philips has also agreed to allocate up to $15 million to reimburse class members who purchased, rented or leased replacement devices between June 14, 2021, and September 7, 2023. To be eligible for the device reimbursement , individuals must meet the following criteria;
- The new device must have been purchased personally by the claimant.
- The purchase date should fall between June 14, 2021, and September 7, 2023.
- At the time of this purchase, Philips should not have provided the claimant with a repaired or rectified version of their recalled device.
Will there be a CPAP Side Effects Lawsuit against Philips?
Yes. Product liability lawsuits are being investigated to pursue Philips Respironics CPAP recall settlements for individuals who have used one of these defective machines for at least three months and experienced any of the following injuries:
- Cancer, Lymphoma, Leukemia or Tumors
- Pulmonary Fibrosis
- Interstitial Lung Disease (ILD)
- Pulmonary Fibrosis
- Auto-Immune Disorders
- Chronic Asthma
- Chronic Bronchitis
- Recurrent Pneumonia
- Kidney Disease
- Liver Disease
- Heart Attack
- Heart Failure
- Wrongful Death
It appears that the manufacturer knew or should have known about the Philips CPAP cancer risk and other long-term injuries that may result from breathing the toxic foam particles and gasses. However, rather than warning users and issuing an immediate Philips CPAP recall, the company placed its desire for profits before the safety of individuals using their sleep apnea machines.
Our Philips Respironics Recall Lawyers Will Protect Your Rights
If you or a loved one may have suffered a physical injury after exposure to a recalled Philips Respironics CPAP machine, BiPAP machine or ventilator, financial compensation may be available from the manufacturer through a Philips CPAP lawsuit settlement for;
- CPAP machine replacement or repair costs;
- Medical bills for treatments required due to the foam problems;
- Monitoring for medical conditions that may develop in the future;
- Lost wages or loss of earnings capacity;
- Pain and suffering;
- Other damages
All cases are reviewed by our Philips Respironics recall lawyers on a contingency fee basis, which means that there are never any out-of-pocket costs to hire an attorney and we only receive fees or reimbursement of expenses if we are successful obtaining a recover or settlement in your case.