Philips CPAP Recall

What is the Philips CPAP Recall?

Philips Respironics issued a voluntary recall on certain CPAP, BiPAP and APAP machine models due to potential health risks. Affected models contain the polyester-based Polyurethane (PE-PUR) sound abatement foam used to reduce sound and vibration. PE-PUR may break down and potentially enter the device’s air pathway. According to Philips’ Website, to date, the company has not identified any cases of PE-PUR breaking down and entering the airway. However, Philips is currently investigating the possibility.

This recall affects Philips machines manufactured between October 1, 2007 and August 31, 2021. Look at the pull-down list to the right of your screen titled “What Devices are Being Recalled?”

If you find your Philips machine model on this list, then check to see if your serial number begins with letters J, P, or C. Those are the machines affected by this recall. To find your serial number, turn your machine over to look at the machine’s bottom. Serial numbers are on the lower left side of the machine. They appear either above or below the barcode. Ignore numbers that begin with the letter H.

If you are not sure which model or year you have, go to Philips Website or call Philips at 1-800-933-9442 for more information. You’ll find handy pictures of models and directions on how to find your serial numbers at that Website.

 

Process for Getting a Replacement Machine.

Philips Respironics established a registration process where you can look up your device serial number then begin a claim if needed.

Register online with Philips Respironics or by phone at 877-907-7508 (Spanish
translation available). Register online here with Philips Respironics

Details of the registration process are as follows:

1. Register at Philip’s dedicated website with your email address and serial number.

2. Receive confirmation email with instructions on how to proceed with the claim process.

3. Once you complete the process, keep your confirmation number and registration email. You’ll need it for proof later.

 

How is ASAA Involved ?

We have been working with sleep apnea patients to gather information about their own experience with the Philips Recall (need more text here especially about the FDA Panel.) Want to help? Please donate to ASAA

 

Why is the FDA Involved?

The US Food and Drug Administration (FDA)’s mission is to protect and promote public health. When a medical device is recalled, the FDA evaluates the health hazard and determines if the device is in violation of the Federal Food, Drug, and Cosmetic Act or otherwise fails to comply with FDA requirements. If a recall order is issued, a company must replace or repair each recalled device as soon as possible, but no later than 15 days after receiving notification from the FDA.

FDA has classified the Philips Respironics recall as a Class I recall, the most serious type of recall. Class I recalls happen when there is a reasonable probability that the use of, or exposure to, a product will cause serious adverse health consequences or death.

The FDA warns consumers of a risk for developing cancer and other diseases from the recalled devices. The FDA said the possible risks of particulate and chemical exposure included asthma, skin and respiratory-tract irritation and “toxic and carcinogenic effects” to
organs including the kidneys and liver.

Table of contents:

  1. What is the Philips CPAP Recall
  2. Process for Getting a Replacement Machine
  3. How is ASAA involved?
  4. Why is the FDA involved?
  5. Philips CPAP Recall FAQ
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Philips Recall FAQ:

The following Philips Respironics machines are being recalled:

E30 (Emergency Use Authorization)
DreamStation ASV
DreamStation ST, AVAPS
SystemOne ASV4
C-Series ASV
C-Series S/T and AVAPS
OmniLab Advanced+
SystemOne(Q-Series)
DreamStation
DreamStation Go
Dorma 400
Dorma 500
REMstar SE Auto
Trilogy 100
Trilogy 200
Garbin Plus, Aeris, LifeVent
A-Series BiPAP Hybrid A30 (not marketed in US)
A-Series BiPAP V30 Auto
A-Series BiPAP A40
A-Series BiPAP A30

You need to register your defective machine with Philips Respironics by going to this website and start the registration process.

In the News:

  • CPAP Recall Over Potential Cancer Risks Leaves Millions Scrambling – The New York Times.
  • Sleep Apnea Patients Struggle as Common CPAP Machine Is Recalled
  • After recalling millions of sleep apnea machines, Philips sued by consumers
  • FMCSA’s Medical Review Board whiffs on attempt to help truckers with recalled CPAPs
  • Patients concerned about lack of communication after Phillips CPAP recall
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