Phillips CPAP Recall Update Q&A

Consumer protection is the safeguarding of the public, as well as of buyers of goods and services, against unfair practices or products in the marketplace. Consumer protection measures are often established by law and other forms of government regulation, such as the Federal Trade Commission (FTC), the Food and Drug Administration (FDA), and the US Department of Justice (DOJ). For example, if a company sells a product that is later found to have contained faulty parts or low-quality components, that would result in it breaking down, not functioning as advertised, or causing harm to the user, the company would have to issue a recall, which would require them to repair or replace the product, or refund the consumer.

The Phillips Recall refers to the Class I recall for Phillips’ ventilators, such as CPAP and BiPAP machines. A Class I recall is the most urgent type of recall issued by the US Food and Drug Administration (FDA), and is ordered in situations in which there is a reasonable probability that the use of or exposure to a violative product (in this case, a Phillips CPAP or BiPAP device) will cause serious adverse health consequences or death. Phillips is required to repair, replace or refund 5.2 million ventilators, distributed worldwide since late 2015. So far, they have manufactured over 2.2 million repair kits and replacement devices for global distribution, and are working on the remaining 3 million.

Yes, the USA has consumer protection laws. A variety of laws at both the federal and state levels regulate consumer affairs in the United States. Among them are:

– The Federal Food, Drug, and Cosmetic Act
– Fair Debt Collection Practices Act
– The Fair Credit Reporting Act
– Truth in Lending Act
– Fair Credit Billing Act
– The Gramm–Leach–Bliley Act

Federal consumer protection laws are enforced by:

– The Federal Trade Commission (FTC)
– The Consumer Financial Protection Bureau (CFPB)
– The Food and Drug Administration (FDA)
– The US Department of Justice (DOJ)

The Food and Drug Administration takes several precautionary measures in order to protect the health and wellbeing of the public, as well as to help consumers make informed decisions. Products must first be approved by the FDA before coming to market, and if a problem was found after the fact, retrospective action must be taken, such as product recalls and safety alerts.

Yes, there are alternatives to CPAP. Mandibular Advancement Devices (MAD) are a smaller, more lightweight alternative that position the jaw forward to keep the airways open. They are custom-fitted for each patient and are less obtrusive than CPAP machines, but may not be recommended in severe cases of obstructive sleep apnea (OSA).
 
If you purchased a Phillips CPAP or BiPAP machine, please be aware of the product recall. If you have any questions about your device or your own wellbeing, please call us at Koala® Center For Sleep & TMJ Disorders today!