US FDA Adds More MDRs To Philips Recall, Including Deaths
Company says it is working to address the recall issues
The US FDA has received more reports of adverse outcomes, including deaths, from the breakdown of foam in many sleep apnea devices from Philips.
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Philips Implements Plan To Address FDA Concerns Following Harsh Inspection Report
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.
Another Headache For Philips As Company Recalls Millions Of Sleeping Masks
The US FDA says a Philips recall of more than 17 million masks worn with some recalled breathing machines raises further safety concerns about other medical devices manufactured by the company.
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.