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Philips Recalls CPAP Machines, Millions of Devices Affected

Written by

Sarah Shoen

Fact Checked

In a major announcement earlier this month, Philips Respironics issued a recall on select BiLevel PAP and CPAP devices as well as select Mechanical Ventilators in the United States. The company also issued a field safety notice to international markets. According to Philips, the issue is related to the polyester-based sound abatement foam component in these devices. The foam component can degrade into toxic particles and/or off-gas chemicals that can be inhaled by the user. Such degradation can occur when the device is cleaned the wrong way or exposed to environments with high heat or humidity.

While Philips has no reported deaths as a result of these issues, the company has received reports of possible patient impact due to foam degradation. Some of the reported symptoms include headache, irritation, inflammation, respiratory issues, and possible toxic and carcinogenic effects.

Which CPAP Devices Are Affected?

CPAP and BiLevel PAP Devices manufactured before April 26, 2021:

Continuous Ventilator, Minimum Ventilatory Support, Facility Use

  • E30 (Emergency Use Authorization)

Continuous Ventilator, Non-life Supporting

  • DreamStation ASV
  • DreamStation ST, AVAPS
  • SystemOne ASV4
  • C Series ASV, S/T, AVAPS
  • OmniLab Advanced Plus In-Lab Titration Device

Non-continuous Ventilator

  • SystemOne (Q series)
  • DreamStation CPAP, Auto CPAP, BiPAP
  • DreamStation Go CPAP, APAP
  • Dorma 400, 500 CPAP
  • REMstar SE Auto CPAP

Mechanical Ventilator Devices manufactured before April 26, 2021:

Continuous Ventilator

  • Trilogy 100 Ventilator
  • Trilogy 200 Ventilator
  • Garbin Plus, Aeris, LifeVent Ventilator

Continuous Ventilator, Minimum Ventilatory Support, Facility Use

  • A-Series BiPAP Hybrid A30 (not marketed in U.S.)
  • A-Series BiPAP V30 Auto Ventilator

Continuous Ventilator, Non-life Supporting

  • A-Series BiPAP A40 (not marketed in U.S.)
  • A-Series BiPAP A30 (not marketed in U.S.)

What Do I Do If My Device Is Affected?

For those using affected life-sustaining mechanical ventilator devices:

  • Don’t stop or change your therapeutic regimen until after you speak with your health care provider. Alternatives may be limited or unavailable. The expert advice of your health care provider is necessary to determine if the benefit of continuing to use the device outweighs the risk of the recall.
  • For more information on this recall, contact your Philips representative or visit www.philips.com/SRC-update.

For those using affected BiLevel PAP and CPAP devices:

  • Discontinue use of your device and work with your health care provider or Durable Medical Equipment (DME) provider to determine your best option for continued treatment. If you lack other alternatives, discuss with your health care provider or DME if the benefit of continuing to use your device outweighs the risks of the recall.
  • To determine if your device is affected, you can register it on the recall website at www.philips.com/src-update.
  • Continue to clean your CPAP machine regularly, to avoid any potential particle build-up.

In a separate announcement, the FDA warned that many at-home CPAP cleaning devices are not legally marketed for cleaning purposes—in fact, you typically won’t need a machine of any kind to clean a CPAP.

Will I Be Eligible for a New Device?

According to Philips, the company is working with the respective agencies to form a correction plan. The company plans to replace the current foam with a new material, and has reportedly already begun preparations to implement the new materials into existing machines. In the statement, the company stressed that they are moving as quickly as possible, due to the importance of these machines.

More information on replacement devices can be found on the claims processing page, found on the Philips website. Affected devices may be repaired under warranty, and Philips will provide further information regarding warranty replacement procedures during this issue when it is available.

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