Philips reaches agreement with US authorities over Respironics devices
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Today, the Dutch company Philips simultaneously with the publication of quarterly and annual reporting announced that it has reached an agreement with the US Food and Drug Administration (FDA) on the issue of Philips Respironics breathing devices.
In 2021, the company announced a recall of Respironics breathing devices sold in the United States, used in the treatment of apnea and for mechanical ventilation. This was done after reports of a defect in the device, due to which the patient could inhale microparticles of the foam used to insulate parts of the mechanism. No injuries were reported during the use of the devices, but Philips suspended sales of the devices in the United States, and the FDA began an investigation.
Today the company announced that it will pay the FDA compensation of €363 million. If the US court approves this agreement, the company will continue to coordinate with the authorities further steps to resolve the situation surrounding the recall, including repair and replacement of devices. In other countries, Philips will sell improved devices.
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