The Food and Drug Administration (FDA) on Thursday classified the recall of Philips’ breathing devices and ventilators as Class 1, or the most serious type of recall, saying the use of these devices may cause serious injuries or death.
The agency said there have been 83 complaints regarding the products used to provide breathing assistance, but no injuries or deaths were reported for these issues.
The Dutch medical equipment company recalled some of its breathing devices and ventilators in June, as the foam used to dampen the machines’ sound could degrade and emit small particles that irritate airways. The gases released may also be toxic or carry cancer risks, Philips had said.
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