The U.S. Food and Drug Administration (FDA) has recalled more than 3.5 million Philips ventilators and CPAP and BiPAP machines sold since 2009 because of serious health risks. According to a report on MassDevice, the FDA has designated the action as a Class I recall, which is the most serious level of recall for medical devices. A spate of complaints about health issues caused by the devices prompted the recall.
Product Defect Details of the Ventilators
So far, more than 1,200 complaints and more than 100 injuries involving polyester-based polyurethane (PE-PUR) sound abatement foam breaking down. The foam can potentially enter a device’s air pathway, causing a host of health problems and toxic, carcinogenic effects for the user.
On June 14, Philips Respironics sent customers an urgent letter telling them to discontinue using 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 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. We urge patients using these devices at home to discuss potential treatment plan adjustments with their doctors. Philips says the benefits of using the devices may sometimes outweigh the risks.
Defective Medical Devices
Defective medical devices have the potential to cause serious health complications. People implant several medical devices, including sleep apnea machines, for external use. When such devices fail, individuals must undergo additional, unnecessary surgeries and deal with related expenses. Manufacturers of medical devices have the responsibility and legal obligation to make them safe for consumers, many of whom already have health vulnerabilities.
Suppose you or a loved one has developed cancer as a result of one of these sleep apnea machines or has suffered adverse health effects as a result of other defective medical devices. In that case, 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/
