CPAP Recalls

The U.S. Food and Drug Administration (FDA) uses recalls to ensure the safety of medical devices Trusted Source U.S. Food and Drug Administration (FDA) The FDA is responsible for protecting the public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices; and by ensuring the safety of our nation's food supply, cosmetics, and products that emit radiation. View Source , including continuous positive airway pressure (CPAP) machines. When safety concerns arise, the FDA can require a recall or encourage the device’s manufacturer to take action to resolve the issue.

In June of 2021, the company Philips Respironics announced a voluntary recall of millions of CPAP machines. The recall also included many bilevel positive airway pressure (BiPAP) devices and ventilators designed to provide breathing assistance. Philips and the FDA warned that a piece of foam inside the devices could break down into smaller pieces Trusted Source American Academy of Sleep Medicine (AASM) AASM sets standards and promotes excellence in sleep medicine health care, education, and research. View Source and put the user’s health at risk.

It is important for people with recalled Philips devices to consult with their doctor about their options. While a major product recall can raise questions and cause concern, getting the facts about the Philips CPAP, BiPAP, and ventilator recall can help individuals, caregivers, and health professionals take the appropriate steps to promote the health of people who use these devices.
 

Types of Devices That Have Been Recalled

The voluntary recall initiated by Philips affects as many as 4 million devices of three different types.

• CPAP devices: A continuous positive airway pressure (CPAP) machine is kept by the bedside and pumps a constant stream Trusted Source U.S. Food and Drug Administration (FDA) The FDA is responsible for protecting the public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices; and by ensuring the safety of our nation's food supply, cosmetics, and products that emit radiation. View Source of pressurized air into the upper airway through the mouth and/or nose. CPAP machines are frequently prescribed to treat obstructive sleep apnea Trusted Source Medline Plus MedlinePlus is an online health information resource for patients and their families and friends. View Source . Some CPAP devices can make real-time modifications to air pressure levels and are known as auto-CPAPs or APAPs.
• BiPAP devices: A bilevel positive airway pressure (BiPAP or BPAP) machine works like a CPAP machine except that the amount of air pressure generated by the device is different during inhalation and exhalation. BiPAP machines can be used to treat sleep-related breathing disorders like obstructive or central sleep apnea. Adaptive servo-ventilation (ASV) devices, which provide bilevel pressure Trusted Source National Library of Medicine, Biotech Information The National Center for Biotechnology Information advances science and health by providing access to biomedical and genomic information. View Source , have also been affected by the recall.
• Ventilators: Ventilators are designed to help make sure that people who have breathing problems get enough oxygen. Depending on the design, they may support or help regulate breathing.

For each of these types of devices, several Philips models are included in the recall.

Currently Recalled Devices

All of the CPAP, BiPAP, and ventilator devices of certain models that were manufactured before April 2021 are subject to the recall . Affected models include:

• DreamStation
• DreamStation Go
• DreamStation ASV
• DreamStation ST, AVAPS
• A-Series BiPAP A30
• A-Series BiPAP Hybrid A30
• A-Series BiPAP A40
• A-Series BiPAP V30 Auto
• C-Series S/T and AVAPS
• Dorma 400
• Dorma 500
• E30
• OmniLab Advanced+
• REMstar SE Auto
• SystemOne ASV4
• SystemOne Q-Series
• Garbin Plus, Aeris, LifeVent
• Trilogy 100
• Trilogy 200

In addition, some Trilogy Evo ventilators with certain serial numbers are part of the recall.

Why Machines Are Being Recalled

The reason for the Philips recall is the potential for degradation Trusted Source UpToDate More than 2 million healthcare providers around the world choose UpToDate to help make appropriate care decisions and drive better health outcomes. UpToDate delivers evidence-based clinical decision support that is clear, actionable, and rich with real-world insights. View Source of a piece of foam inside the device.

In recalled machines, Philips used a polyester-based polyurethane (PE-PUR) foam to reduce the noise produced by devices. However, there is evidence that this foam is at risk of breaking apart into smaller pieces that could create health risks if breathed in or swallowed. The foam may also emit potentially hazardous chemicals.

Possible Health Risks From Recalled Devices

Using one of the recalled Philips devices poses several potential health risks. If the foam in the device breaks apart, small pieces can be ingested or inhaled. The foam itself may also off-gas chemicals that could be inhaled through the device. This raises the risk of health problems, including:

• Respiratory tract irritation
• Cough
• Headache
• Dizziness
• Sinus infections
• Asthma
• Allergic or other inflammatory reactions
• Irritation of the eyes, nose, and skin
• Nausea and vomiting
• Pressure in the chest

There are also concerns that using a recalled device could increase a person’s risk of developing cancer. However, studies to date have not found any association between recalled devices and increased cancer risk. More robust and long-term research is needed to determine if there are any carcinogenic effects of using a recalled device.

Recommendations for Users of a Recalled Philips Machine

People who have a recalled CPAP or BiPAP machine should talk with their doctor before they stop using their device. Because these devices can be important for treating sleep apnea, for some people the risks of stopping CPAP or BiPAP therapy can be greater than the risks posed by a recalled device .

In many cases, a doctor may suggest switching to another brand or model of CPAP or BiPAP device. If this is not possible, the doctor may recommend continuing to use the recalled device or trying other treatments for sleep apnea.

In addition, people with recalled machines can register the device with Philips in order to receive a replacement. However, it may take time to receive a new device as Philips does not expect to complete the repair and replacement process until the end of 2022.

Other Practical Tips for People With Recalled Devices

As part of the recall, the FDA and Philips have offered a number of suggestions for people with affected devices and their caregivers.

• Report any symptoms: If any symptoms arise that may be related to using a recalled device, it is important to notify a doctor. These health effects can also be reported to the FDA’s MedWatch program.
• Do not alter the device: People should not try to take the foam out of the machine, which may affect the device’s performance and disperse foam particles or chemicals. Trying to add a filter to the device is also not recommended.
• Avoid unapproved cleaners: The FDA has not approved any cleaning products for CPAP devices that use ozone or ultraviolet (UV) light Trusted Source U.S. Food and Drug Administration (FDA) The FDA is responsible for protecting the public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices; and by ensuring the safety of our nation's food supply, cosmetics, and products that emit radiation. View Source . Using these cleaners may pose health risks and could cause the PE-PUR foam to break down more quickly. Instead, it is important to carefully follow the manufacturer’s instructions for cleaning CPAP machines and other devices.

Advice for Health Care Providers Related to the Philips Recall

The American Academy of Sleep Medicine (AASM) has provided guidance to health care providers Trusted Source American Academy of Sleep Medicine (AASM) AASM sets standards and promotes excellence in sleep medicine health care, education, and research. View Source about how to care for people who use devices involved in the recall. When available, the AASM suggests prescribing CPAP or BiPAP treatment with a device that was not recalled.

If this is not an option, the AASM recommends that health care providers work closely with their patients to discuss the benefits and risks of each available option, including continuing to use a recalled device. Consultation and collaboration can help identify the approach that best fits an individual’s specific needs and preferences.

Information on Repairing or Replacing a Machine

As part of the voluntary recall, Philips established a program to repair or replace affected devices. As of September 2022, Philips has produced more than 3.3 million updated devices. Although the company has accelerated manufacturing , the process is expected to last until at least December 2022.

What Are the Steps to Get a New Device?

Getting a new device requires registering the affected machine with Philips. This can be done online, and Philips provides instructions on how to find the device’s serial number . Philips will confirm that the affected device has been registered, and encourages individuals to save all confirmation details.

A notification will be sent when a new device is ready to ship. Once it is received, the new machine can be set up for use, and the recalled device must be sent back to Philips. The company covers all shipping costs associated with the recall.

Is There a Way to Speed Up the Repair or Replacement Process?

Priority access may accelerate the process of getting an updated device from Philips.

In conjunction with the FDA, Philips has set up a program to provide priority access to a replacement for people with defined medical needs. Priority is determined based on questions about a person’s health that are asked during the process of registering a device for replacement.

Priority access is not a guarantee of faster delivery of a replacement device, but it may influence the order in which new devices are distributed.

Are Replacement Devices Safe?

Replacement devices from Philips use a silicone-based foam instead of the PE-PUR foam that was identified as a risk in the recall.

The FDA has stated that there is a lack of detailed data about the safety of silicone-based foam. While initial evaluations have not shown problems, the FDA has received reports of potential off-gassing of chemicals from the new foam.

While the replacement material eliminates the known problems tied to PE-PUR foam, more evidence is needed to fully evaluate the safety of silicone-based foam in new devices.