What to Know About Philips CPAP and Ventilator Recall
Editor's Note: This article was updated on September 28, 2021.
In June 2021, Philips announced a recall 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 (BiPAP)
- Mechanical ventilator devices
Officials from Philips found that a foam used to reduce sound may break down and enter the air pathway. This foam may have health risks when inhaled. To fix this, the FDA announced in September 2021 that Philips can begin replacing or repairing the devices this month.3
The replacement effort is complicated because the devices are currently in shortage due to COVID-19. Talk to your doctor about what to do if you use an affected device. They may suggest using a similar device or other treatments while you wait for a replacement.
Why were these devices recalled?
The ventilators and machines were recalled because of the “sound abatement foam.” The foam is made out of polyester-based polyurethane (PE-PUR). It decreases sound during use and reduces vibrations caused by the device.2,4
After reviewing user reports and lab data, Philips found that the foam may have health risks. It may break down into small particles that enter the airway during use. Inhaling the foam particles can cause:4,5
- Irritation to airways, eyes, and skin
- Sinus infections
- Kidney or liver problems
The foam can also create other gases while the device is in use. These gases can reach unsafe levels and cause:4
- Nausea or vomiting
- Headache or dizziness
- Irritation to airways, eyes, and skin
- Allergic reactions
There have not yet been any reports of serious harm. Philips has only received reports of minor symptoms or black residue in the devices. Storing the devices in hot or humid climates may cause a greater risk. Cleaning the device with unapproved methods may also increase the risk.1,2
How do I know if my device is affected?
Not all Philips CPAP, BiPAP, and mechanical ventilator devices are recalled. Some use different types of foam or store the foam differently. To see if your device has been recalled, visit the Philips website or the U.S. Food and Drug Administration (FDA) recall notification.
How do I get a replacement device?
Philips and the FDA are working together to implement a plan to fix the recalled products. To get your device replaced or repaired, you should register it with Philips. To register your device, follow the instructions on the Philips website.
During the registration process, you can look up your device serial number and begin a claim. You can also call Philips at 1-877-907-7508 instead to complete this process.1
Philips will then keep you informed of the company's progress. The FDA will also share more updates as information becomes available.6
When will my device get replaced?
Philips is starting the repair and replacement program in September 2021. The company has already started replacing certain affected DreamStation CPAP devices in the United States. However, officials from Philips say the repair and replacement program will take about a year to complete.3,6
Unfortunately, many of the recalled devices are in shortage. Limited machines are available due to COVID-19. Replacing the foam may be a quicker option than waiting for a replacement machine. Either way, it is unclear how long the repair and replace program will take.6,7
What do I do if I cannot wait for a replacement device?
First, confirm that your device is included in the recall. If your device is on the recall list and you cannot wait for a repair or replacement, talk to your doctor. They will help you figure out what to do, which may include:2,6
- Using a similar device that is not part of the recall
- Using alternative treatments for sleep apnea
- Starting long-term therapies for sleep apnea
- Continuing to use the recalled device if your doctor determines that benefits outweigh risks
Follow the recommendations for storing and cleaning your device. Do not try to remove the foam yourself. Do not stop or change your device use without talking to your doctor first.6
How do I know the repaired device is safe?
The FDA has begun inspecting Philips manufacturing facilities to make sure they comply with regulations. They are also working with Philips to make sure the company provides evidence of the safety and effectiveness of its repairs.6
Thus far, the FDA has reviewed and approved of Philips’ plan to fix some of the recalled devices. They are continuing to review information on repairing the rest of the devices. As the FDA reviews the information, officials will determine what other risks the devices pose.6
Do any of your family or friends have sleep apnea?