FDA Issues Notice Requiring Philips to Notify Consumers About CPAP Recall

 Posted on March 25, 2022 in Recalled Devices

Since June of 2021, Philips Respironics, a Dutch medical device manufacturer, has been undertaking a massive recall of CPAP devices and other types of ventilators. This recall was initiated because the devices used a sound abatement foam that could potentially cause harm to users. When this foam breaks down over time, “black debris” consisting of foam particles may be inhaled by those using the devices, and volatile organic compounds or other dangerous chemicals may also be released. Users of the devices may be at risk of lung injuries and other serious illnesses. 

The CPAP recall involves around 2.6 million devices in the United States and 5.2 million devices worldwide. While Philips has made efforts to notify users about the recall, many people have been unable to receive replacement devices. The U.S. Food and Drug Administration (FDA) recently issued a notification stating that the company’s efforts to ensure that people are properly informed about the recall have been lacking, and it is requiring Philips to take certain actions to comply with its requirements.

FDA Requirements Addressing Inadequate Notification Procedures

To determine whether the actions taken by Philips to notify people about the recall have been effective, the FDA contacted 182 suppliers of CPAP devices and other medical equipment. It found that 28 of these suppliers were not aware of the recall, meaning that their customers were also most likely unaware of the potential risks that may affect them when they use these devices.

To ensure that Philips is providing people with the proper notification of the recall, the FDA is requiring the company to notify all suppliers and users of these products. The company must request contact information for each patient or healthcare provider who has received a recalled device and contact these people within 30 days, or it must confirm that suppliers have contacted all patients and providers. Philips will also be required to include prominently-displayed information on its website about the risks of using ozone cleaners on CPAP machines. 

The FDA is also recommending that Philips develop a strategy to encourage patients or other consumers to register recalled devices, as well as steps the company can take to improve communication with these registrants. This includes providing people with estimates and monthly updates regarding when they will be able to receive replacement devices, as well as tracking systems that will allow people to look up the status of their replacements. Philips should also respond to consumers who call the company’s recall assistance phone number within 24 hours. 

Contact Our CPAP Recall Attorneys

If you are a user of a recalled CPAP machine, you will need to determine the steps you can take to protect yourself from injury while also ensuring that you will be able to receive the proper treatment for sleep apnea or other related conditions. Our CPAP injury lawyers can advise you of your rights and options, and we can help you determine whether you can take legal action to address health issues that you have experienced due to your use of a recalled device. Set up a free consultation with our attorneys today to get legal help with your case.

Sources:

https://www.fda.gov/news-events/press-announcements/fda-orders-philips-respironics-notify-patients-regarding-recall-certain-breathing-assistance

https://www.fda.gov/media/156811/download

https://www.fiercebiotech.com/medtech/fda-slams-philips-inadequate-efforts-notify-patients-suppliers-cpap-recall