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Recalled Philips Ventilators, BiPAP Machines, and CPAP Machines

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.

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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

Additional Resources


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).

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