AMSTERDAM—Philips clarified that 2.2 million devices it has repaired or replaced in a major recall of respiratory devices are actually in the hands of patients in the United States.
The Dutch healthcare equipment maker issued a statement on April 14 clarifying progress of the recall program underway since 2021 after the Food and Drug Administration (FDA) issued a statement on April 13 saying that the number of devices the company had replaced was “considerably less” than the 2.46 million indicated on the company’s website.
The FDA on April 7 classified the recall of Philips’ respiratory machines as its most serious type, as their use could cause serious injuries or death….