Philips reportedly withheld CPAP problems from the FDA for years

Philips (NYSE: PHG) + received the first complaints of degraded sound abatement foam in its respiratory devices in 2010, but 11 years passed before it turned into a major recall, according to a ProPublica and Pittsburgh Post-Gazette investigation published today. 

According to ProPublica, Philips withheld the vast majority of the warnings about black particles, dirt, dust and other contaminants in devices airway chambers from the FDA even as the reports became more alarming each year.

It wasn’t until 2021 that Philips initiated a recall that now covers 5.5 million CPAPs and other devices. Since April 2021, the FDA received 105,000 reports of problems, including 385 reports of deaths associated with the foam degradation issue. (Here is MassDevice‘s full timeline of the recall.) After he took over in 2022, Philips CEO Roy Jakobs apologized for the recall on behalf of the Dutch medtech giant is deeply sorry ab…

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