Recalled Philips Ventilators, BiPAP Machines, and CPAP Machines

In June 2021, Philips Respironics (Philips) recalledExternal Link Disclaimer certain ventilators, bi-level positive airway pressure (also known as Bilevel PAP, BiPAP, or BPAP) machines, and continuous positive airway pressure (CPAP) machines 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 the foam breaks down, black pieces of foam, or certain chemicals that are not visible, could be breathed in or swallowed by the person using the device.

The problems reportedly associated with the PE-PUR foam breakdown could potentially result in serious injury and may require medical intervention to prevent permanent injury. The PE-PUR foam breakdown issue may result from exposure to hot and humid conditions and may be worsened by using ozone cleaners or other cleaning methods not recommended by the manufacturer.

• Recalled Devices
• Medical Device Recall Database Entries
• Additional Resources
• Questions?

• Recommendations for
• FDA Activities Related to
• Foam Testing Summary for
• Problems Reported with  

Philips recalled the following devicesExternal Link Disclaimer 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.

• A-Series BiPAP A 40, A-Series BiPAP A30 Continuous Ventilator, Non-life Supporting
• A-Series BiPAP Hybrid A30 (not marketed in US), A-Series BiPAP V30 Auto Continuous Ventilator, Minimum Ventilatory Support, Facility Use
• Trilogy 100, Trilogy 200, Garbin Plus, Aeris, LifeVent Continuous Ventilators
• Continuous Ventilator, Non-life Supporting: DreamStation ASV, DreamStation ST, AVAPS, SystemOne ASV4, C-Series ASV, C-Series S/T and AVAPS, OmniLab Advanced+
• E30 with Humidifier Continuous Ventilator, Minimum Ventilatory Support, Facility Use
• Noncontinuous Ventilators SystemOne (Q-Series), DreamStation, DreamStation Go, Dorma 400, Dorma 500, REMstar SE Auto 

• FAQs: Philips Respironics Ventilator, BiPAP Machine, and CPAP Machine Recalls
• CDRH Statement (October 5, 2023): CDRH Provides Update on Philips June 2021 Recall and Maintains Recommendations Related to Potential Health Risks of PE-PUR Foam
• FDA News Release (September 6, 2022): Certain Philips Respironics Masks for BiPAP, CPAP Machines Recalled Due to Safety Issue with Magnets That May Affect Certain Medical Devices
• FDA News Release (March 10, 2022): FDA Orders Philips Respironics to Notify Patients Regarding the Recall of Certain Breathing Assistance Machines
• FDA News Release (November 12, 2021): FDA Provides Update on Recall of Certain Philips Respironics Breathing Assistance Machines
• Updated Safety Communication (November 12, 2021): UPDATE: Certain Philips Respironics Ventilators, BiPAP Machines, and CPAP Machines Recalled Due to Potential Health Risks
• Safety Communication (June 30, 2021): Certain Philips Respironics Ventilators, BiPAP, and CPAP Machines Recalled Due to Potential Health RisksExternal Link Disclaimer
• Philips' Recalls Not Associated with the Foam Issue

For more information on Philips’ recall notification, contact your local Philips representative or visit Philips' medical device recall information pageExternal Link Disclaimer.

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

If you have additional questions, contact the FDA’s Division of Industry and Consumer Education (DICE).