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FDA classifies Philips recall as ‘serious’

FDA classifies Philips recall as ‘serious’

AMSTERDAM – The U.S. Food and Drug Administration has classified the voluntary recall of certain Philips CPAP devices and ventilators as Class I.  

The FDA defines Class I as “a situation in which there is reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.” 

The agency posted recalls for the various affected devices, along with their classification, to its database on July 13 and July 22. 

Philips announced the recall on June 14 to address identified potential health risks related to the polyester-based polyurethane sound abatement foam component in the affected devices. It says the foam may degrade into particles that may enter the device’s air pathway and be ingested or inhaled by the user, and it may off-gas certain chemicals. 

The company awaits regulatory clearances from the FDA to replace the foam with a new material.  


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