Recall Of Sleep, Ventilator Devices Lead To International Patient Suits For Philips
Patients in Canada and the US are suing Philips over issues related to the company’s recent recall of CPAPs, BiPAPs, and mechanical ventilators.
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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.
Damning FDA-483: Philips Didn’t Investigate 222,000 Complaints Of Possible Degraded Foam In Breathing Devices
Royal Philips has been reeling from a June recall of millions of breathing machines, and now it’s been slapped by the US FDA with multiple observations after an on-site inspection. One observation says the company didn’t open formal investigations after receiving hundreds of thousands of complaints of particles and other contaminants when the recalled devices were used.
Apnimed is going to conduct one more Phase II study in sleep apnea, mainly to assess subjective endpoint questionnaires, and then hopes to launch a Phase III program by autumn of 2022.