The FDA announced that Philips will pay a $400 million settlement over a sleep apnea device recall linked to 561 deaths.
CBS News report The U.S. Food and Drug Administration (FDA) reports 561 deaths related to recall of Philips respirators and respirators used to treat sleep apnea and other respiratory conditions did. The statistics were announced after Philips agreed to pay $400 million to settle lawsuits over defective devices.
Philips announced in June 2021 that it would be purchasing millions of continuous positive airway pressure (CPAP) and bilevel positive airway pressure (BiPAP) devices after customers complained that the internal foam was deteriorating and invading airways. ) equipment was first recalled. The company later also recalled a repair kit to fix the problem.
Since April 2021, the FDA said it has received more than 116,000 reports of foam in recalled machines breaking and releasing harmful particles. This includes 561 reported deaths potentially related to device use.
“We have found no conclusive data linking these devices to the reported deaths,” Phillips said in a statement. But under a proposed legal settlement with the Department of Justice, the company will pay $400 million and stop selling the machines in the United States until certain safety conditions are met.
File/Jenny Shields poses for a photo with a CPAP machine that has been recalled for safety reasons at her home in Wilmington, Delaware, on June 3, 2022. (Rachel Wisniewski/The Washington Post)
The proposed settlement also includes a $479 million payment to compensate affected U.S. customers. Individuals may make claims for economic losses related to the purchase or rental of recalled products. There’s also a $100 return benefit if you return your recalled device by August 2024.
Approximately 30 million Americans suffer from sleep apnea, a condition in which a person repeatedly stops breathing during sleep. The patient relies on her CPAP machine, which provides constant airflow to keep the airways open.
There is growing alarm among consumer advocates about the potential risks of these widely used Philips devices. Phillips maintains that the settlement does not indicate liability, but Diana Zuckerman of the National Center for Health Research argues that “hundreds of deaths could have been prevented if the FDA had done its job properly.” I think that’s it.
Users can check whether they are eligible for device payment benefits by searching their device serial number. here. Customers who return recalled Philips machines before August can receive return and payment benefits without filing a claim form. Prepaid shipping labels are It’s available here for free.
If you purchased a replacement CPAP or ventilator with your own money to replace a recalled device, you must complete a device replacement request form to receive a refund.Claim forms can be found online here Alternatively, you can obtain a paper form by Please apply here.
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Lucas Nolan is a reporter for Breitbart News, covering free speech and online censorship issues.
