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Philips CPAP Machines

On June 30th, 2021 the US Food and Drug Administration (FDA) announced a “Class 1” recall of certain Philips Respironics CPAP, BiPAP and ventilator machines. A “Class 1” recall is the most serious type of recall, only used when the defective product could cause serious injury or death.

 

What is the problem with Philips CPAP machines?
The FDA has determined that the polyester-based polyurethane (PE-PUR) foam used to decrease vibrations and sounds in these devices can break down, potentially causing debris from the foam as well as related chemicals to be inhaled by the user.

 

What should I do if I have one of these devices?
If you are using one of these devices, you should immediately consult with your doctor to determine the best course of action. While most users are recommended to stop use, in some cases the risks from these devices may be outweighed by the benefits of the therapy provided by the device. Your health care provider is the only person who should determine what your best course of action is.

 

 

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If the problem with my Philips CPAP machine is caused by the sound abatement foam, should I remove this foam from my device?

No. According to FDA guidance, you should not remove the sound abatement foam from your Philips CPAP device as it may impact performance and introduce debris to the devices air passageway.

 

Who is responsible for fixing these issues with my Philips CPAP machine?

As a Philips CPAP recall has been issued by the FDA, the manufacturer (Philips Respironics) is responsible for resolving any issues with your Philips CPAP machine.

 

Who is liable for any damages I incur due to use of my Philips CPAP machine?

If you suffer from an injury related to this Philips CPAP recall, the manufacturer of the device is the primary liable party. In addition, if you are put on a Philips ventilator in a health care setting, the healthcare provider in question is required to remain up to date with all medical device recalls and if they fail to do so they may also be liable. The best way to determine where liability lies is by speaking with an attorney that specializes in Product Liability cases, like the lawyers at Stewart & Stewart.

 

What devices are included in this Philips CPAP recall?

The following devices are included in the Class 1 Recall of Philips CPAP, BiPAP and Ventilator devices:

  • Philips Respironics E30
  • Philips Respironics DreamStation ASV
  • Philips Respironics DreamStation ST, AVAPS
  • Philips Respironics SystemOne ASV4
  • Philips Respironics C-Series ASV
  • Philips Respironics C-Series S/T and AVAPS
  • Philips Respironics OmniLab Advanced+
  • Philips Respironics SystemOne Q Series
  • Philips Respironics Dreamstation
  • Philips Respironics Dreamstation Go
  • Philips Respironics Dorma 400
  • Philips Respironics Dorma 500
  • Philips Respironics REMstar SE Auto
  • Philips Respironics Trilogy 100
  • Philips Respironics Trilogy 200
  • Philips Respironics Garbin Plus
  • Philips Respironics Aeris
  • Philips Respironics LifeVent
  • Philips Respironics A-Series BiPAP V30 Auto
  • Philips Respironics A-Series BiPAP Hybrid A30
  • Philips Respironics A-Series BiPAP A40
  • Philips Respironics A-Series BiPAP A30

If I have suffered an injury due to a defective Philips CPAP machine, what should I do?

First, you should contact your doctor to determine the best course of action to treat any issues caused by these devices. Once you have received adequate medical care, you should reach out to a product liability attorney like the lawyers at Stewart & Stewart to determine if you have a valid case for damages. We offer free case evaluations and consultations to help you determine if legal action is warranted.

 

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