Philips Announces Recall: 124 Suspected Deaths Tied to CPAP Machines
Philips Respironics, a subsidiary of the company Royal Philips, was issued a notice by the US FDA requiring the company to notify durable medical equipment (DME) suppliers, distributors, retailers, patients, and healthcare providers of the company’s 2021 recall of specific ventilators, CPAP, and BiPAP machines. In addition, Philips Respironics was served subpoenas by the U.S. Department of Justice as part of an ongoing investigation into the recall.
The voluntary recall, originally announced in June of 2021, for CPAP, BiPAP, and ventilator devices was due to the noise-abatement foam used in these devices. The foam is carcinogenic and can break down to the point that it is unknowingly inhaled by the user. The FDA labeled the recall a Class One designation, typically reserved for only the most serious types of recall.
This recall impacted over 15 million devices worldwide. Philips did not have enough parts to immediately repair and replace the CPAP and BiPAP devices that many sleep apnea patients rely on. This left many patients without options. If you are affected by the recall and need to continue vital sleep apnea treatment, reach out to the professionals at Sleep Better Columbus. Using a compromised sleep apnea device or going without treatment can have serious consequences for your health.
The FDA has received more than 21,000 reports associated with the breakdown of the noise-abatement foam inside these devices since April 2021. Those reports include 124 deaths associated with the recalled devices. These medical device reports are a combination of reports from Philips in addition to voluntary reports from patients, consumers, and health professionals.
The suspected deaths are still being investigated. In the meantime, many users of the recalled devices find themselves facing a decision to go without treatment, find alternative treatment, or risk potential death. Philips Respironics also acknowledged they are currently facing 185 personal injury lawsuits and more than 100 class-action lawsuits related to the recall. Learn more about reporting medical device problems through the FDA.
About: Sleep Better Columbus is dedicated to providing sleep-disordered patients with high-quality care. Dr. Levy has a lifetime of experience in the treatment of sleep apnea, snoring, headaches, and TMJ. He has lectured nationally and internationally and currently holds Diplomate status with the Academy of Clinical Sleep Disorder Disciplines. Sleep Better Columbus specializes in helping patients find and acquire alternative treatment options for obstructive sleep apnea. Reach out to Sleep Better Columbus to learn more about CPAP alternatives.
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