21 June 2021
Breas Information following the recent publication of a recall / field safety notice by Philips Respironics.
On 14 June 2021, Royal Philips published a recall / field safety notice for a number of their ventilator and sleep device models.
After this notification, Breas has, out of an abundance of caution, performed a technical investigation of our biocompatibility and verification reports, and a review of the relevant complaints in our Quality Management System (QMS).
Our technical investigation demonstrated that none of the potentially harmful substances reported in the Philips recall were detected in our biocompatibility tests, and particulate matter levels were in all cases below safe exposure levels; and our review of complaints in our QMS between 2011 and 2021 also confirms that Breas devices are safe to use.
In addition, the sound silencers in our Vivo 45, 45LS, and Nippy 4/4+ ventilators do not use foam and those in our Vivo 1-2-3, 30, 40, 50, 60, 55, and 65 ventilators, as well as Z1, Z2, and iSleep sleep therapy devices, have different sound silencing materials than reported by Philips.
In summary, our investigations confirmed that our devices can continue to be used with confidence. We emphasize that the Instructions for Use of our devices must be followed regarding cleaning and maintenance procedures.
For any questions, please contact your local Breas representative or Breas Technical Support.