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Royal Philips
Philips issues recall notification to mitigate potential health risks related to the sound abatement foam component in certain sleep and respiratory care devices
Philips issues recall notification to mitigate potential health risks related to the sound abatement foam component in certain sleep and respiratory care devices
June 14, 2021
Philips is initiating a voluntary recall notification to ensure patient safety in consultation with regulatory agencies
Corrective actions include the deployment of updated instructions for use and a repair and replacement program for affected devices
Philips aims to address all affected devices within the scope of this correction as expeditiously as possible
June 14, 2021
Philips is initiating a voluntary recall notification to ensure patient safety in consultation with regulatory agencies
Corrective actions include the deployment of updated instructions for use and a repair and replacement program for affected devices
Philips aims to address all affected devices within the scope of this correction as expeditiously as possible
Amsterdam, the Netherlands – Following the company
update on April 26, 2021,
Royal Philips (NYSE: PHG; AEX: PHIA) today provides an update on the recall notification for specific Philips Bi-Level Positive Airway Pressure (Bi-Level PAP), Continuous Positive Airway Pressure (CPAP), and mechanical ventilator devices to address identified potential health risks related to the polyester-based polyurethane (PE-PUR) sound abatement foam component in these devices. The majority of the affected devices within the advised 5-year service life are in the first-generation DreamStation product family.
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