What is the Philips Recall?
Philips Respironics has issued a voluntary recall on certain machines due to potential health risks. The polyester-based polyurethane (PE-PUR) sound abatement foam, which is used to reduce sound and vibration in these affected devices, may break down and potentially enter the device’s air pathway. The company has not yet identified any cases of PE-PUR breaking down and entering the airway, but it is currently investigating this 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 has established a registration process that allows you to look up your device serial number and begin a claim if your unit is affected.
- Register with Philips Respironics by phone at 877-907-7508 (Spanish translation available)
- Register online with Philips Respironics
The details of the online registration process are as follows:
- Register at Philip’s dedicated website with your email address and serial number.
- Receive confirmation email with instructions on how to proceed with the claim process.
How is ASAA Involved ?
We have been working with sleep apnea patients to gather information about their own experience with the Philips Recall.
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 presented by the product issue 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.
The FDA has classified the Philips Respironics recall as a Class I recall, the most serious type of recall. Class I recalls present a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.
The Agency is warning consumers of a risk of developing cancer and other diseases from the recalled devices. The FDA said the possible risks of particulate and chemical exposure from the recalled devices included asthma, skin and respiratory-tract irritation and “toxic and carcinogenic effects” to organs including the kidneys and liver.
In The News
The FDA’s Center for Devices and Radiological Health (CDRH) suggested this week that the agency issue an order requiring Philips, the manufacturer of recalled PAP devices manufactured after November 2015 to submit a plan for repair, replacement, or refund of the purchase price. Due to potential health hazards, Philips Respironics voluntarily recalled some ventilators last…