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FDA Issues Class I Recall for Philips CPAP Machines Over Health Concerns

The U.S. Food and Drug Administration (FDA) has recalled more than 3.5 million Philips ventilators as well as CPAP and BiPAP machines that were sold since 2009 because of serious health risks.

According to a report on MassDevice, the FDA has designated this as a Class I recall, which is the most serious level of recall for medical devices.

The recall was issued after a spate of complaints about health issues caused by the devices.

Product Defect Details

So far, there have been more than 1,200 complaints and more than 100 injuries involving polyester-based polyurethane (PE-PUR) sound abatement foam breaking down. The foam has the potential to enter a device’s air pathway, causing a host of health problems as well as toxic carcinogenic effects for the user.

On June 14, Philips Respironics sent customers an urgent letter telling them to discontinue any use of their machines until the manufacturer can replace the PE-PUR foam sound abatement component with the new silicone foam sound abatement component. The ventilators and the CPAP and BiPAP machines were all made between April 11, 2007, and April 22, 2021, and were distributed nationwide between July 21, 2009, and April 22, 2021. More information can be found on the FDA’s website.

Philips is one of the largest manufacturers of sleep apnea machines and ventilators. Patients who have these devices at home are urged to consult with their doctors about whether to adjust their treatment plans. Philips says in some cases, the benefits of continuing to use the devices may outweigh the risks.

Defective Medical Devices

Defective medical devices have the potential to cause serious health complications. While sleep apnea machines are for external use, there are a number of medical devices that are implanted. When such devices fail, individuals are forced to undergo additional, unnecessary surgeries, and deal with related expenses. Manufacturers of medical devices have the responsibility and legal obligation to make devices that are safe for consumers many of whom already have health vulnerabilities.

If you or a loved one has developed cancer as the result of one of these sleep apnea machines or has suffered adverse health effects as a result of other defective medical devices, you may be able to seek compensation for your injuries, damages, and losses. An experienced California product defect lawyer can help you pursue maximum compensation for the losses you have endured.


Source: https://www.massdevice.com/philips-cpap-recall-is-class-i/

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