Medical Device Recall - Philips Respironics

Recall

Medical Device Recall - Philips Respironics

14 July 2021
Submitted by admin on 14 July 2021

On June 23, 2021 Health Canada posted a medical device recall for many of the Philips Respironics positive airway pressure (PAP) devices and ventilators. This was due to possible harm secondary to breakdown of the polyester based polyurethane (PE-PUR) sound abatement foam. The hazard classification is type II, defined as a situation in which the use of, or exposure to, a product may cause 2 temporary adverse health consequences or where the probability of serious adverse health consequences is remote.  A variety of devices are potentially affected including:  

  • Bipap Autosv With Smartcard Int 
  • Bipap Autosv With Smartcard Int, Core Pkg 
  • Bipap Synchrony Ventilatory Support System With Smartcard 
  • Bipap Synchrony Ventilatory Support System With Smartcard-Core Pack 
  • Trilogy 100 Ventilator, Canada 
  • Trilogy 100 Ventilator-International 
  • Bipap Avaps Core Package, North America 
  • Bipap Autosv Advanced/Encore Smartcard 
  • Bipap Autosv Advanced/Encore Smartcard/Heated Humidifier 
  • Trilogy 200, Canada 
  • Bipap A30 System-Ventilator 
  • Bipap A30 System-Ventilator & System One A-Series Heated Humidifier 
  • Bipap A40, Canada 
  • Bipap A40, Canada, Core Package 

The Canadian Thoracic Society (CTS) and partners have put out a statement that includes further information and recommendations. If you are impacted, or have any other questions, it is important you speak with your doctor before making any changes to your therapy. 

Health Canada Recall Notices 
https://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2021/75887r-eng.php
https://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2021/75889r-eng.php 
 

Philips Statement On Recall  
https://www.philips.ca/healthcare/e/sleep/communications/src-update#section_2