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Tag: FDA Classification


FDA classifies Philips recall as ‘serious’

July 26, 2021HME News Staff

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...

CPAP, FDA Classification, Philips, Recall, ventilator

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