What to Know About Philips CPAP and Ventilator Recall

After many months of investigation, Philips has announced a recall notification for many of its devices. The medical device company analyzed risks related to several products, including:^1,2

• Continuous positive airway pressure (CPAP)
• Bi-level positive airway pressure (bi-level PAP)
• Mechanical ventilator devices

In the United States, the affected products are recalled. For international markets, a field safety notice has been issued.^1,2

Why were these products recalled?

The recall centers around sound abatement foam in the affected devices. The foam is made out of polyester-based polyurethane (PE-PUR). It decreases sound during use and reduces vibrations caused by the device. However, after studying several user reports and reviewing lab data, Philips found that the foam may have health risks.^1,2

Potential foam-related health issues

Specifically, the foam can degrade into small particles that may enter the respiratory tract during use. These particles can have many health impacts, such as:^1-3

• Irritation to the respiratory tract, eyes, or skin
• Sinus infections
• Headache
• Kidney or liver problems

It is also possible for the foam to create other gases while the device is in use. Lab tests have shown that it is possible for these gases to reach levels that exceed safe limits. Some of these chemical gases can cause health issues, such as:^1-3

• Nausea or vomiting
• Headache or dizziness
• Irritation to the respiratory tract, eyes, or skin
• Allergic reactions

The degraded particles and other gases may also have cancer-causing properties. Plus, respiratory irritation may lead to severe issues in those who already have lung problems.^1-3

Has anyone experienced these issues?

So far, Philips has received reports of minor symptoms or black residue in the devices. However, there have been no reports of serious harm. It is thought that devices stored in environments with high heat or humidity may be at a greater risk. It is also more likely for the foam to degrade if the device is cleaned using unapproved methods like ozone.^1,2

How do I know if my device is affected?

Not all Philips CPAP, bi-level PAP, and mechanical ventilator devices are affected by the recall. Some use different types of foam. Other devices that use the same foam may store it differently so it does not directly contact the user, unlike those under the recall.^1,2

To see if your device is affected by the recall, visit the Philips website. You can also register your device so you can be notified with more information as it becomes available.

Philips is working to repair or replace all impacted devices. Those in the United States who cannot access the website or who have further questions can call Philips at 877-907-7508.^1,2

What should I do now?

If you use a CPAP or BiPAP device that is affected by the recall, Philips recommends you stop using it right away. Contact your doctor as soon as possible to find a different treatment option or for more instructions.

If you or a loved one uses a mechanical ventilator affected by the recall, do not stop using the device on your own. This could be life-threatening. Due to issues finding a new ventilator and the support they provide, the benefits of continuing to use the affected device may outweigh the risk. Talk to your doctor right away so you can create a plan that is right for you.^1-3