Philips continues to monitor reports of potential safety issues through our post-market surveillance activities as required by medical device regulations and laws in the markets in which we operate. High heat and high humidity environments may also contribute to foam degradation in certain regions. Possible health risks include exposure to degraded sound abatement foam, for example caused by unapproved cleaning methods such as ozone, and exposure to chemical emissions from the foam material. only) / field safety notice (International Markets) informs customers and users of potential impacts on patient health and clinical use related to this issue. Additionally, the notification provides details of our robust and comprehensive repair and replacement program, to correct this issue as efficiently and thoroughly as possible. only) / field safety notice (International Markets) informs customers and users of potential impacts on patient health and clinical use related to this issue, as well as instructions on actions to be taken.
only) / field safety notice (International Markets) for specific affected devices. As a result of extensive ongoing review following this announcement, on June 14, 2021, the company issued a recall notification (U.S. The company also indicated that analysis of potential health risks was ongoing, and that further information would be provided when available.
#Philips recall update#
On April 26, 2021, Philips provided an important update regarding proactive efforts to address identified issues with a component in certain products of our Sleep & Respiratory Care portfolio.Īt that time, out of an abundance of caution and based on available information, Philips advised of potential health risks related to sound abatement foam used in specific Philips Continuous Positive Airway Pressure (CPAP), BiLevel Positive Airway Pressure (BiLevel PAP) devices, and Mechanical Ventilators.