Philips Recalls Reworked Ventilators

The FDA is providing additional information about two recent issues in certain reworked Philips Respironics (Philips) Trilogy 100 and Trilogy 200 ventilators. These Philips Trilogy 100 and Trilogy 200 ventilators were recalled in June 2021 for issues with the polyester-based polyurethane (PE-PUR) sound abatement foam breakdown. The two recent issues are:

• The silicone sound abatement foam, installed to replace the PE-PUR foam, may separate from the plastic backing due to adhesive failure, and block the airpath, which may reduce air flow in the ventilator.
• Philips observed residual PE‐PUR sound abatement foam in some reworked Trilogy 100 and Trilogy 200 ventilators that were returned to customers. Further exposure to PE-PUR foam may cause potential health risks, which can result in serious injury, cause permanent impairment, and require medical intervention to prevent permanent injury to users. 

Read the FDA safety communication.