Date Issued: 11/12/2021

The U.S. Food and Drug Administration (FDA) is updating the June 2021 safety communication about the Philips Respironics (Philips) recalled ventilators, bilevel positive airway pressure (also known as Bilevel PAP, BiPAP, or BPAP) machines, and continuous positive airway pressure (CPAP) machines. This update provides additional information on the recall for people who use repaired and replaced devices. At this time, the FDA is not changing the recommendations from the previous June 2021 safety communication.

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Recalled Devices

In June 2021, Philips recalled certain ventilators, BiPAP machines, and CPAP machines (see table below) because of potential health risks. The polyester-based polyurethane (PE-PUR) foam used in these devices to reduce sound and vibration can break down. 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 and require medical intervention to prevent permanent injury. The PE-PUR foam issue may result from exposure to hot and humid conditions and may be exacerbated by the use of 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 recalled 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
• DreamStation ASV
• DreamStation Go
• DreamStation ST, AVAPS
• Dorma 400
• Dorma 500
• E30
• Garbin Plus, Aeris, LifeVent (ventilator)
• OmniLab Advanced+
• REMstar SE Auto
• SystemOne ASV4
• SystemOne (Q-Series)
• Trilogy 100 (ventilator)
• Trilogy 200 (ventilator)

Philips also recalled certain Trilogy Evo ventilators distributed from April 15, 2021 to May 24, 2021 with specific serial numbers.

Description of the Devices

The devices are used to help breathing. Three types of devices have been recalled:

• A continuous ventilator mechanically controls or helps patients' breathing while delivering a set amount of oxygen.
• A BiPAP machine pumps air under varying pressure into the airway of the lungs. BiPAP machines use a higher pressure when you breathe in and lower pressure when you breathe out. These devices are also prescribed to people with obstructive sleep apnea to keep their airways open during sleep.
• A CPAP machine keeps your airway open by providing a stream of air at a continuous pressure through a mask. CPAP machines are often prescribed to people with obstructive sleep apnea to keep their airways open during sleep.

Recalled Ventilators

Recommendations for People Who Use Recalled Ventilators at Home and Their Caregivers

• Do not stop or change ventilator use until you have talked to your health care provider.
• Talk with your health care provider about using an inline bacterial filter, which may help to filter out pieces of PE-PUR foam, as indicated in the Philips recall notification. At this time, the information provided by Philips has not established that the filters can reduce the PE-PUR foam's risks. The FDA's evaluation of the information provided by Philips is ongoing. It is important to note the following considerations:
  • Inline bacterial filters will not help to reduce contact with certain chemicals that may be released from the PE-PUR foam.
  • Inline bacterial filters may make the ventilator work less well because they may increase resistance of air flow through the device.
  • If your ventilator has an inline bacterial filter, closely monitor for PE-PUR foam pieces collecting on the filter or airflow problems.
• Register your device(s) on Philips' recall website or call 1-877-907-7508 to provide important additional information to help prioritize replacement of your device and to get updated information from Philips. For Spanish translation, press 2; Para español, oprima 2.
• If you have a health issue, including those listed under potential health risks below, or any problem with your device, talk to your health care provider and report the issue or problem through the MedWatch Voluntary Reporting Form.

Recommendations for Health Care Providers and Facilities

• Follow the recommendations above for the recalled devices used in health care settings.
• Review the recommendations above with patients who use the recalled devices, including that for some patients, stopping use of the device may involve greater risk than continuing to use the recalled device.
• If you treat a patient who has a health issue, including those listed under potential health risks below, or have any problem with a device, report the issue or problem through the MedWatch Voluntary Reporting Form.

Recalled BiPAP or CPAP Machines

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 (see How to Know if You Should Stop Using Your Device in FAQs on Philips Respironics Ventilator, BiPAP Machine, and CPAP Machine Recalls).
  • 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:
• Follow Philips' instructions for recommended cleaning of your CPAP machine and accessories.
• Register your device(s) on Philips' recall website. If you already registered your device and want to be considered for prioritized replacement of your device, you may update your existing registration on the Philips' online patient portal and provide additional information. You may visit the online patient portal and update your information even if you did not receive an email notification from Philips. If you do not provide the additional requested information, you will receive a replacement device based on when you registered. You may also check the status of your replacement device on Philips' online patient portal or by calling 1-877-907-7508. For Spanish translation, press 2; Para español, oprima 2.
• Do not use an additional filter with a CPAP or BiPAP machine.
• Do not try to remove the PE-PUR 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 PE-PUR 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.

Repaired and Replaced BiPAP or CPAP Machines

Recommendations for People Who Use BiPAP or CPAP Machines Replaced by Philips and Their Caregivers

• Be aware that during the manufacturing facility inspection, the FDA obtained additional information, not previously available to the FDA, regarding the silicone-based foam used in a similar device marketed outside the U.S., which failed one safety test for the release of certain chemicals of concern, called volatile organic compounds (VOCs).
  • Similar testing provided by Philips to the FDA on devices authorized for marketing in the U.S. had demonstrated acceptable results.
  • The FDA has requested that Philips retain an independent laboratory to perform additional testing to determine what, if any, potential safety risks may be posed to patients by the silicone-based foam.
  • At this time, the FDA does not have sufficient information to conclude whether the silicone-based foam being used in the repaired devices poses any risk to patients in the U.S.
• Continue to use your repaired or replaced device.
  • If you have additional concerns, talk to your health care provider about the plan for your care and treatment.
  • The results from the independent testing are needed to determine if the silicone-based foam used in the repaired devices does in fact present any risks to patients.

Potential Health Risks from PE-PUR Foam

PE-PUR Foam

PE-PUR foam is used to lessen sound and vibration in these devices and other medical equipment. The PE-PUR foam used in the recalled devices may break down and can result in serious injury, cause permanent impairment, and require medical intervention to prevent permanent injury to users.

When the PE-PUR foam breaks down, it may:

• Break down (degrade) into black pieces that may enter the device's air tubes and be inhaled or swallowed by the user. You may or may not see black pieces of the foam in the air tubes or masks.
• Release certain chemicals, such as VOCs into the device's air tubes and be inhaled by the user.
  • The breakdown of the PE-PUR foam may result from exposure to hot and humid conditions. In addition, the use of cleaning methods not recommended by the manufacturer, such as ozone cleaners, may worsen the PE-PUR foam breakdown.

The potential risks of particulate exposure if inhaling or swallowing pieces of PE-PUR foam include:

• Irritation to the skin, eyes, nose, and respiratory tract (airway)
• Inflammatory response
• Headache
• Asthma
• 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:

• Headache
• Dizziness
• 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

Silicone-based Foam

During the 2021 manufacturing facility inspection, the FDA obtained additional information, not previously available to the FDA, regarding the silicone-based foam used in a similar device marketed outside the U.S., which failed one safety test for the release of VOCs. Similar testing provided by Philips to the FDA on devices authorized for marketing in the U.S. had demonstrated acceptable results. The FDA has requested that Philips retain an independent laboratory to perform additional testing to determine what, if any, potential safety risks may be posed to patients by the silicone-based foam. The FDA is aware that patients have already received devices with silicone-based foam as part of the repair and replace program.

Currently, while this independent testing is performed, the FDA does not recommend that patients who have participated in the repair and replace program discontinue use of their product. The FDA has reached this determination based on an overall benefit-risk assessment. At this time, the FDA has determined that discontinuing use of one of these devices may be more harmful to a patient's health and quality of life. The results from the independent testing are needed to determine if the silicone-based foam used in the repaired devices does in fact present any risks to patients, and the FDA will communicate those results to the public as soon as they are available. Patients who have additional concerns should talk to their health care provider about the plan for their care and treatment.

Medical Device Reports

Manufacturers, such as Philips, are required to submit medical device reports (MDRs) when information reasonably suggests that their device may have caused or contributed to a death or serious injury, or has malfunctioned and that device or a similar device they manufacture would be likely to cause or contribute to a death or serious injury if the malfunction were to recur. Health professionals, consumers, and patients may voluntarily submit reports of device adverse events and malfunctions to the FDA.

Philips submitted 30 MDRs between 2011-April 2021 that they identified as associated with the PE-PUR foam breakdown. Eight of those reports were from the U.S. There were no reports of patient injury or death among those 30 MDRs.

Since April 2021 through April 30, 2022, the FDA received more than 21,000 MDRs, including 124 reports of death, associated with the PE-PUR foam breakdown or suspected foam breakdown. The MDRs received included both mandatory reports from Philips and voluntary reports from health professionals, consumers, and patients. A wide range of injuries have been reported in these MDRs, including cancer, pneumonia, asthma, other respiratory problems, infection, headache, cough, dyspnea (difficulty breathing), dizziness, nodules, and chest pain.

Although MDRs are a valuable source of information, this passive surveillance system has limitations. The incidence, prevalence, or cause of an event cannot typically be determined from this reporting system alone due to under-reporting of events, inaccuracies in reports, lack of verification that the device caused the reported event, and lack of information about frequency of device use. Because of these limitations, MDRs comprise only one of the FDA's several important postmarket surveillance data sources. These reports, along with data from other sources, can contribute important information to a medical device's benefit-risk assessment. The FDA continues to review and assess the MDRs and will keep the public informed as new information becomes available.

FDA Actions

See the latest FDA Actions in the FAQs on Philips Respironics Ventilator, BiPAP Machine, and CPAP Machine Recalls.

Reporting Problems to the FDA

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.

Questions?

The FDA posted answers to frequently asked questions about this recall: FAQs on Philips Respironics Ventilator, BiPAP Machine, and CPAP Machine Recalls.

For more information on the company's recall notification, contact your local Philips representative or visit Philips' recall notification web page.

More information on medical device recalls, including What is a Medical Device Recall, is available on FDA.gov.