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.
At 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.
The company also indicated that analysis of potential health risks was ongoing, and that further information would be provided when available. As a result of extensive ongoing review following this announcement, on June 14, 2021, the company issued a recall notification (U.S. only) / field safety notice (International Markets) for specific affected devices.
The recall notification (U.S. 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. Additionally, the notification provides details of our robust and comprehensive repair and replacement program, to correct this issue as efficiently and thoroughly as possible.
For patients using life-sustaining mechanical ventilator devices:
For patients using BiLevel PAP and CPAP devic es:
Philips has established a registration process that allows Patients, Users, or Caregivers to look up their device serial number and begin a claim if their unit is affected.
For more information on this Field Safety Notification, please visit Philips.com/SRC-Update.
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