Philips reaches compliance agreement with FDA over ventilator recall
Amsterdam: Dutch health technology company Philips said on Monday it had reached an agreement on the terms of a settlement with the U.S. Food and Drug Administration (FDA) over a large-scale recall of ventilators.
Philips said the costs of the so-called consent decree with the FDA led to a provision of 363 million euros ($393.5 million) in the fourth quarter of last year, and were expected to be about 1 per cent of total revenues in 2024.
The agreement sets out the improvements that Philips needs to make at its Respironics plants in order to be able to sell new respiratory devices in the U.S. again.
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Until the conditions are met, no new Respironics devices will be sold there, the company said.
"We are fully committed to complying with the consent decree, which is an important step and provides a clear path forward," Chief Executive Roy Jakobs said in a statement.
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