Philips recalled its machines in June 2021, which affected millions of sleep apnea patients. The FDA designated the recall as a Class 1 recall because continued use of the sleep machines could cause potentially life-threatening health problems. At the same time, the agency advised users to use the sleep devices for life-sustaining use only but it didn’t count on the recall and repair program being so difficult. So, millions of users went without necessary sleep therapy and those patients who continued to use the recalled machines have suffered a wide range of illnesses – and death.
More CPAP Health Issues
CBS News reported in March that sleep apnea sufferers are still experiencing problems with the CPAP machines. And one user describes the botched recall. Carrie Markham, a 48-year-old registered nurse in Florida found out on Facebook that machines like hers had been recalled – she never received a recall notice from Philips. Now she is suing the company. Philips told CBS that as of January 2023 it has "produced more than 90% of replacement devices that are needed." In other words, it has “shipped replacements to about 2.5 million customers, roughly half of those who needed them.”
Philips and FDA Recall Update
In June 2021 Philips claimed the recall was due to "potential risks" that included "toxic and carcinogenic effects," along with the possibility of developing "asthma" and an "inflammatory response." Since that time, many lawsuits claim that Philips knew since 2015 about foam degradation and potential serious health issues but waited about six years to initiate the recall.
The FDA released a CPAP machine health risks update in early February 2023 for people who use repaired and replaced devices. It also provided new information about medical device reports (MDRs) received between November 1, 2022 and December 31, 2022.
The FDA reports that, of the 30 MDRs submitted by Philips between 2011-April 2021 that they identified as associated with the PE-PUR foam degradation (breakdown), there were no reports of injury or death. However, since April 2021, the FDA has received more than 98,000 MDRs, including 346 reports of death, reportedly associated with the PE-PUR foam breakdown or suspected foam breakdown.
Philips Sleep Machines Lawsuit Update
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randy l ernst
Someone should be doing something about it...