After CPAP Recall, Are Replacement Machines Safe?

Earlier this year, Philips Respironics issued a voluntary – but urgent – recall of sleep apnea machines, citing that a breakdown of materials in the machine could be inhaled by users and cause serious health issues, such as cancer. Now, it appears that the replacement devices may also put consumers at risk, according to a recent report in the Wall Street Journal.

In June, Phillips, one of the largest manufacturers of sleep apnea machines and ventilators, recalled some 4 million machines, saying that the polyurethane foam used to dampen the operating sound and vibration of the machines could degrade, emit harmful gases, and include carcinogenic particles that could be inhaled by users. In a new complication, the Food and Drug Administration (FDA) is warning that the replacement devices may do the very same thing.

The FDA approved the replacement devices based on test results provided by Philips. However, during an inspection of one of the company’s production sites, the FDA found a similar device sold outside the United States that had failed the safety test due to the foam. The agency instructed Philips to have an independent laboratory test the foam. The result of those tests will determine whether another recall is necessary.

If you have questions about this or another product that you fear may have caused a serious health issue, you may want to contact an attorney experienced in catastrophic personal injury cases. Our firm is recognized as a leader in litigating injury cases throughout Pennsylvania.