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Update: April 2024
On April 9, 2024, a federal district court entered a consent decree against Philips Respironics (Philips). The consent decree includes key provisions aimed to prioritize patient relief and ensure the company's regulatory compliance. The consent decree comes after Philips recalled certain ventilators, continuous positive airway pressure (CPAP) machines, and bi-level positive airway pressure (BiPAP) machines in June 2021 because of potential health risks—impacting 15 million devices worldwide. Patients impacted by the Philips recall remain a top priority for the agency as the FDA continues to take steps to protect the health and safety of individuals using these devices.
The consent decree includes provisions:
- Requiring implementation of a Recall Remediation Plan, agreed to by the FDA and Philips, to help ensure relief is provided to patients impacted by the recall by way of receiving a new or reworked/remediated device, or for certain devices, providing the option for a partial refund.
- Restricting, with limited exceptions, the production and sale of new CPAP machines, BiPAP machines, and other devices at several Philips Respironics facilities in Pennsylvania and California until certain requirements are met.
For more information, see the FDA's press release.
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In June 2021, Philips Respironics (Philips) recalled 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.
On this page:
- Recalled Devices
- Medical Device Recall Database Entries
- Additional Resources
- Questions?
Related FDA pages
- Recommendations for Recalled Philips Ventilators, BiPAP Machines, and CPAP Machines
- FDA Activities Related to Recalled Philips Ventilators, BiPAP Machines, and CPAP Machines
- Foam Testing Summary for Recalled Philips Ventilators, BiPAP Machines, and CPAP Machines
- Problems Reported with Recalled Philips Ventilators, BiPAP Machines, and CPAP Machines
Recalled Devices
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.
Medical Device Recall Database Entries
- 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
Additional Resources
- FDA News Release (April 9, 2024): Federal Court Enters Consent Decree Against Philips Respironics Following Recall of Certain Sleep Therapy Machines
- CDRH Statement (January 29, 2024): CDRH Statement on Philips' Announcement
- 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(Archived)
- Safety Communication (June 30, 2021): Certain Philips Respironics Ventilators, BiPAP, and CPAP Machines Recalled Due to Potential Health Risks
- Philips' Recalls Not Associated with the Foam Issue
Questions?
For more information on Philips' recall notification, contact your local Philips representative or visit Philips' medical device recall information page.
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).
