Philips has reported two potential issues with Respironics Trilogy ventilators that were recalled in June 2021 and reworked, the Food and Drug Administration announced last week. The silicone sound abatement foam used to replace the polyester-based polyurethane foam may separate from the plastic backing, potentially blocking the air inlet and lowering inspiratory pressure, FDA said. Philips also found trace amounts of particulate matter in the air pathway of some reworked ventilators. The FDA has requested additional information from Philips to better understand the cause of the issues and inform recommendations, and said it will inform the public as more information becomes available.

Related News Articles

Headline
The Food and Drug Administration this week alerted health care providers to a shortage of tracheostomy tubes, used to help people breathe after a…
Headline
The Food and Drug Administration yesterday revised its emergency use authorizations for all COVID-19 antigen tests to authorize serial testing and require…
Headline
All hospitals may request a backup controller with modified software for the Heartware Ventricular Assist Device System to use in certain circumstances if the…
Headline
Exela Pharma Sciences this week recalled 49 lots of sodium bicarbonate injection because the vial may break while preparing the product for administration…
Headline
The FBI today released recommendations to help protect medical devices from cyberattacks that can threaten health care operations, patient safety, and…
Headline
The AHA last week encouraged the Bureau of Land Management to work with the Health and Human Services Assistant Secretary for Preparedness and Response,…