Philips Respironics Recall 2021 -CPAP and BiPAP Machines


Philips DreamStation CPAP Recall Updates (2022)

On June 2022 Philips Respironics has issued a recall notification for patients using CPAP and BiPAP machines that they produced. Philips advises patients to discontinue use of affected units and consult with physicians to determine the benefits of continuing therapy and potential risks. Philips has established a registration process that allows Patients, Users, or Caregivers​ to look up their device serial number and begin a claim if their unit is affected. CPAP Store USA is unable to answer any questions about recalled units or what Philips’ actions around the recall will be.



Philips RECALL Qs and As

Q: Why Did Philips Respironics Issue a Voluntary CPAP Recall?

A: Philips Respironics identified there is risk the PE-SUR sound abatement foam “may degrade into particles which may enter the device’s air pathway and be ingested or inhaled by the user, and the foam may off-gas certain chemicals. The foam degradation may be exacerbated by use of unapproved cleaning methods, such as ozone, and high heat and high humidity environments may also contribute to foam degradation.”


Q: What are the health risks of the affected CPAP & BiPAP recalled units?

Per Philips Respironicspossible health risks include exposure to degraded sound abatement foam and exposure to chemical emissions from the foam material. High heat and high humidity environments as well as unapproved cleaning methods such as ozone, may also contribute to foam degradation.

The Philips Respironics FAQs state:

In the event of exposure to degraded foam:

  • “The potential risks of degraded foam exposure include: Irritation (skin, eye, and respiratory tract), inflammatory response, headache, asthma, adverse effects to other organs (e.g. kidneys and liver) and toxic carcinogenic affects.”
  • “To date, Philips Respironics has received several complaints regarding the presence of black debris/particles within the airpath circuit (extending from the device outlet, humidifier, tubing, and mask). Philips also has received reports of headache, upper airway irritation, cough, chest pressure and sinus infection.”

In the event of exposure to chemical emissions:

  • “The potential risks of exposure due to chemical emissions from affected foam include: headache/dizziness, irritation (eyes, nose, respiratory tract, skin), hypersensitivity, nausea/vomiting, toxic and carcinogenic effects.”
  • “To date, Philips has not received reports of patient impact or serious harm as a result of this issue.”

Q: How do I find out if my Philips Device was Recalled?

A: You would have to visit Philips Respironic’s official website and register your device to find out if it has been affected by the recall. During the registration process, Philips Respironics will either let you know your machine is not included in the recall or provide you with a confirmation number.

To register your device and check if your CPAP or BIPAP machine is part of the recall:

  1. Locate the serial number of your device. The label on the bottom of the unit features a series of letters and numbers that follow the SN or S/N on the label. If you need assistance finding your serial number, you can use this handy guide.
  2. Go to Philips Respironics recall website.
  3. Complete the registration form. Provide your information such as your name, address, and phone number so Philips Respironics can contact you regarding this recall. Be sure to use your current personal information, regardless of the information you provided at the time of purchase.
  4. Watch for confirmation. Once you’ve completed your registration, if your machine is not included, you will see a message saying your device is not included in the recall. If your machine was included in the recall, you will receive a registration confirmation number as well as important recall updates from Philips Respironics. Please be sure to save the confirmation number provided for your records. Along with your confirmation number, you will receive information about the next steps in the recall process from Philips Respironics. 

Q: Which Devices Have Been affected by the Philips Respironics Recall?

A: Please see the list bellow…

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
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 US)
A-Series BiPAP V30 Auto Ventilator
Continuous Ventilator, Non-life Supporting
A-Series BiPAP A40 (not marketed in US)
A-Series BiPAP A30 (not marketed in US)

Q: Which Devices Have NOT Been affected by the Philips Respironics Recall?

Products not affected by this recall notification (U.S. only) / field safety notice (International Markets) include:

  • DreamStation 2
  • M-Series
  • Trilogy Evo
  • Trilogy Evo OBM
  • Trilogy EV300
  • Trilogy 202
  • BiPAP A40 EFL
  • BiPAP A40 Pro
  • Omnilab (original based on Harmony 2)
  • Dorma 100, Dorma 200, & REMStar SE
  • All oxygen concentrators, respiratory drug delivery products, airway clearance products.