The U.S. Food and Drug Administration (FDA) is updating the June 2021 safety communication on Philips Respironics recalled ventilators, BiPAP, and CPAP machines.
This update provides additional information on the recall and recommendations for people who use repaired and replaced devices. As the FDA continues to work diligently on this recall and develop solutions, we will continue to share information with the public and provide additional recommendations to patients and health care providers.
In June 2021, Philips Respironics recalled certain ventilators, BiPAP, and CPAP machines (see table below) because of potential health risks. The polyester-based polyurethane foam used in these devices to reduce sound and vibration can breakdown. If this occurs, black pieces of foam, or certain chemicals that are not visible, could be breathed in or swallowed by the person using the device. These issues could potentially result in serious injury, which can be life-threatening and require medical intervention to prevent permanent injury. The foam issue may get worse in hot and humid settings, and by using ozone cleaners or other cleaning methods not recommended by the manufacturer.
If you use one of these recalled devices, follow the recommendations listed below.
Philips Respironics is recalling the following devices made between 2009 and April 26, 2021.
- A-Series BiPAP A30
- A-Series BiPAP A40 (ventilator)
- A-Series BiPAP Hybrid A30
- A-Series BiPAP V30 Auto (ventilator)
- C-Series ASV (ventilator)
- C-Series S/T and AVAPS
- DreamStation ASV
- DreamStation Go
- DreamStation ST, AVAPS
- Dorma 400
- Dorma 500
- Garbin Plus, Aeris, LifeVent (ventilator)
- OmniLab Advanced+
- REMstar SE Auto
- SystemOne ASV4
- SystemOne (Q-Series)
- Trilogy 100 (ventilator)
- Trilogy 200 (ventilator)
Recalled BiPap or CPAP: Recommendations for People Who Use Recalled BiPAP or CPAP Machines and Caregivers
- Talk to your health care provider to decide if the plan for your care and treatment should change as a result of this recall. Your provider may advise you to:
- Stop using your recalled device
- Use another similar device that is not a part of this recall.
- Continue to use your recalled device, if you and your health care provider decide that the benefits of using it outweigh the potential health risks listed below.
- Use other treatments for sleep apnea, such as:
- Positional therapy, such as elevating the head of your bed, using a device that prevents you from turning to your side or back, or avoiding sleeping on your back.
- Oral appliances, which fit like a sports mouth guard or an orthodontic retainer.
- Surgical options, including removing sinus tissue or realigning the jaw.
- Make lifestyle changes, such as:
- Lose weight
- Avoid alcohol
- Stop smoking
- Follow Philips Respironics’ instructions for recommended cleaning of your CPAP machine and accessories.
- Do not use ozone or ultraviolet (UV) light cleaners. Ozone cleaners may breakdown the foam, even if you do not see the pieces of foam in the air tubes, and there are other potential risks associated with the use of ozone and ultraviolet (UV) light products for cleaning CPAP machines and accessories.
- Register your device(s) on Philips Respironics’ recall websiteExternal Link Disclaimer (for Spanish, Iniciar proceso de registroExternal Link Disclaimer) to get updated information from Philips Respironics.
- Do not use an additional filter with a CPAP or BiPAP machine.
- Do not try to remove the foam from your device. Trying to or successfully removing the foam may damage the device or change how the device works. It may also lead to more foam or chemicals entering the air tubing of the device.
- If you have a health issue, including those listed below, or any problem with your device, talk to your health care provider and report the problem through the MedWatch Voluntary Reporting Form.
Potential Health Risks from Sound Abatement Foam
Polyester-based polyurethane (PE-PUR) foam is used to lessen sound and vibration in these devices and other medical equipment. This particular foam may breakdown and can result in serious injury, which can be life-threatening, cause permanent impairment and require medical intervention to prevent permanent injury to users:
- Breakdown (degrade) into black pieces that may enter the device’s air tubes and be inhaled or swallowed by the user.
- Release certain dangerous chemicals, such as volatile organic compounds (VOCs), into the device’s air tubes, and be inhaled by the user.
- The foam damage may get worse in hot and humid settings, and by use of unapproved cleaning methods, such as ozone cleaners and ultraviolet (UV) light products.
If the foam breaks down, you may or may not see black pieces of the foam in the air tubes or masks.
The potential risks of particulate exposure inhaling or swallowing pieces of foam include:
- Irritation to the skin, eyes, nose, and respiratory tract (airway)
- Inflammatory response
- Toxic or cancer-causing effects to organs, such as kidneys and liver.
The potential risks of inhaling chemicals released into the device’s air tubes from the PE-PUR foam include:
- Irritation in the eyes, nose, respiratory tract (airway), and skin
- Hypersensitivity reaction, such as an allergic reaction or another immune system reaction
- Nausea or vomiting
- Toxic and cancer-causing effects.
Reporting Problems with Your Device
If you have a health issue, including any of the health issues listed above, or any problem with your device, the FDA encourages you to talk to your health care provider and report the problem through the MedWatch Voluntary Reporting Form.
Health care personnel employed by facilities that are subject to the FDA's user facility reporting requirements should follow the reporting procedures established by their facilities.