Philips Respironics Medical Device Recall Notification

7/22/2021

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), Bi-Level 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.


Philips has shared a medical recall notification which you can read here. 

 

The notification advises patients and customers to take the following actions:

 

  • For patients using BiLevel PAP and CPAP devices: 
    Discontinue use of affected units and consult with physicians to determine the benefits of continuing therapy and potential risks.
     
  • For patients using life-sustaining mechanical ventilator devices: 
    DO NOT discontinue or alter prescribed therapy, without consulting physicians to determine appropriate next steps.


Philips is recommending that customers and patients do not use ozone-related cleaning products. 


Additionally, Philips is reminding customers and patients to review the age of their BiLevel PAP and CPAP devices, as they are recommended to be replaced after five years of use.

Back to News