Philips remains in dialogue with the FDA with respect to other aspects of the recall notification and mitigation plan in the US. In addition to the rework, the company has already started replacing certain affected first-generation DreamStation CPAP devices in the US with DreamStation 2 CPAP devices. Philips anticipates rework to commence in the course of September 2021. Philips received authorization from the US Food and Drug Administration (FDA) for the rework of the affected first-generation DreamStation devices, which consists of replacement of the PE-PUR sound abatement foam with a new material. The vast majority (>80%) of the registered affected devices in the US to date are in the first-generation DreamStation product family. More than half of the affected devices in use globally are in the US.
Amsterdam, the Netherlands – Royal Philips (NYSE: PHG AEX: PHIA) today announced an update in connection with the Jrecall notification* for specific Philips sleep and respiratory care devices that was issued to address potential health risks related to the polyester-based polyurethane (PE-PUR) sound abatement foam component in these devices.
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