Philips Cites Plastic Contamination Concerns In Latest Recall Of Sleep Apnea Devices
Philips Respironics has recalled more of its BiPAP machines, this time due to the potential for plastic contaminants to be inhaled or shut down the machine.
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The US FDA has labelled as class I an August recall of Philips Respironics BiPAP machines due to the potential of hazardous chemicals being inhaled by the user or shutting down the machines.
The US FDA has received more reports of adverse outcomes, including deaths, from the breakdown of foam in many sleep apnea devices from Philips.
After a lengthy inspection of a Philips facility that manufactured several recalled breathing and ventilator devices, the US Food and Drug Administration delivered a pointed report to the company highlighting multiple risk management and quality systems issues. In response, Philips wrote to the FDA outlining steps it plans to take to fix the problems.