In June, 2021, Dutch health care company Royal Philips initiated a voluntary recall of millions of CPAP machines and mechanical ventilators.
Which CPAP machines are recalled?
The recall involves several models of CPAP, BiPAP and mechanical ventilator devices. A full list of recalled products is available on the Philips website.
Why did Royal Philips issue a recall on its CPAP machines and ventilators?
At issue is the foam used to muffle the sound and vibration of the motor. The foam can disintegrate, releasing toxic debris and chemicals into the air hose. If inhaled or swallowed, the emissions can cause headaches, asthma, lung problems and cancer. According to the FDA, “These issues could potentially result in serious injury and require medical intervention to prevent permanent injury.”
The recalled machines have resulted in 21,000 reports to the FDA and over 100 deaths. Despite the risks, Philips’ progress in replacing the machines has been slow. The company reports it has replaced only about half of the 2.8 million affected devices in the U.S. and slightly over half of the 5.5 million machines around the world.
How do I register my Philips CPAP recall?
If you have not done so already, you need to register your device online at this website.
It is important that you talk to your healthcare provider to determine the best course of action. Your healthcare provider can help determine if you should stop using the device or if the benefits of continued use outweigh the risks.
Why is my CPAP machine not included in the recall?
There are two possible reasons:
- Some devices are manufactured with a newer type of foam for sound and vibration reduction that is not prone to the issues that resulted in the recall.
- Some designs have the foam in an area where there is no way for it to enter the airways.
How can I know that my CPAP machine is safe after a repair?
All recalled devices are thoroughly disinfected after the old foam is removed and will receive a new blower and air pathway. The new foam is a silicone foam that was cleared for use by the FDA.
What should I do if I have been injured by a recalled Royal Philips CPAP machine or ventilator?
The attorneys at PCVA have helped recover millions of dollars for those who have been injured by defective products. If you or a loved one was injured by a recalled Royal Philips machine in Washington State, reach out to us to speak with a lawyer by completing our intake form or calling us at (253) 948-3199 or (206) 536-2850. All conversations are confidential.
Learn more about the recall:
Philips Respironics Recalls Certain Continuous and Non-Continuous Ventilators, including CPAP and BiPAP, Due to Risk of Exposure to Debris and Chemicals
For sleep apnea patients with recalled CPAP machines, restless nights
Philips and U.S. Justice Dept. in consent decree talks on sleep apnea, ventilator recall