Philips Clarifies Respiratory Device Replacement Numbers After New FDA Rebuke

Philips Clarifies Respiratory Device Replacement Numbers After New FDA Rebuke
Philips Healthcare headquarters in Best, Netherlands, on Aug. 30, 2018. Piroschka van de Wouw/Reuters
Reuters
Updated:

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.