What You Need to Know About the Philips PAP Device Recalls
September 8, 2023
Access news and resources related to recalls of Philips Respironics CPAP, BiPAP, and mechanical ventilator devices. CHEST is monitoring these recalls and actively engaging with Philips and partner associations on behalf of you and your patients.
Latest updates
September 7, 2023: According to a statement from Royal Philips, the company has reached an agreement to resolve all economic loss claims in the US Multidistrict Litigation related to Philips Respironics’ voluntary recall of certain sleep and respiratory care devices. The agreement will provide predefined cash awards to all eligible participants in the US depending on the type of device, extended warranties on all replacement devices, and an additional cash award if they return the recalled device to Philips Respironics. The settlement will further compensate certain individuals who acquired replacement devices post-recall.
August 14, 2023: Philips recalled Trilogy Evo, Evo O2, EV300, and Evo Universal ventilators after detecting environmental contaminants in the air path of some devices. Extended exposure to contaminants like dust and dirt can lead to buildup that may block air vents and cause the device to stop delivering the correct level of breathing support. The US Food and Drug Administration (FDA) identified this as a Class I recall.
June 2, 2023: The US Food and Drug Administration (FDA) updated their previous notice from August 2022 with information on Philips' medical device reports (MDRs). The MDRs show 385 reports of death associated with PE-PUR foam breakdown or suspected foam breakdown in certain ventilators, BiPAP machines, and CPAP machines.
September 6, 2022: Certain Philips masks for BiPAP and CPAP machines were recalled due to a safety issue with magnets that may affect certain medical devices. See an additional statement from Philips.
August 29, 2022: The US Food and Drug Administration (FDA) distributed a notice that Philips has recalled certain BiPAP machines that may contain a plastic contaminated with a non-compatible material.
January 26, 2022: Philips recalled certain Trilogy EVO Ventilators for potential health risks from PE-PUR foam.
Resources on June 2021 recall
In June 2021, Philips announced a recall of certain CPAP, BiPAP, and mechanical ventilator devices due to potential health risks from the polyester-based polyurethane (PE-PUR) sound abatement foam used in affected devices. Since then, a number of resources have been released from Philips, the FDA, and other entities.
Philips PE-PUR Testing Results and Conclusions: Philips has released a report with updated information on testing results and third party confirmed conclusions to date on results and findings from testing PE-PUR foam used in recalled devices for volatile organic compounds, particulate matter, and other testing.
Information on Patient Prioritization: Philips has shared details on how the company is prioritizing remediation of those patients potentially at higher risk.
Clinical Bulletins: Access communications from Philips that update physicians on recent developments, as well as provide status updates on remediation efforts.
Understanding the Recall Process: A new webpage from Philips gives patients an overview of the recall process and enables them to check the status of their order.
FDA Safety Communication: The FDA has issued recommendations for patients, health care providers, and facilities.
Device Registration Process: Patients with affected devices should register their devices with Philips.
AASM Resource Page: The American Academy of Sleep Medicine (AASM) offers guidance for clinicians, such as sample patient communications, clinical assessment tools, webinar recordings, and more.
Position Statement: Canadian Thoracic Society, Canadian Sleep Society, and Canadian Society of Respiratory Therapists: These societies have provided guidance to physicians and medical device distributors with regard to the recent recall notice.
Clinician infographic
CHEST has compiled information for clinicians on what approach to use for patients whose devices may be part of the Philips recall, emphasizing shared decision-making between patients and their health care providers.
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For your patients
CHEST’s Sleep Medicine Network has created an easy reference sheet to help patients understand what steps to take, potential health risks, insurance information, and recommendations from Philips.
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