The U.S. Food and Drug Administration (FDA) has updated its communication regarding the Philips Trilogy Evo Platform Ventilator recall, following Philips' clarification of recall reasons and revised guidance on nebulizer use.
Philips, in an April 24 letter to users, updated its recommendation for non-pneumatic nebulizers. Previously advised against, these nebulizers may now be used with Trilogy Evo Ventilators, provided they are placed according to specific guidance and instructions on patient circuits.
As of May 27, Philips has reported no additional serious injuries or deaths related to these issues, though three serious injuries were previously associated. The FDA classifies this as a Class I recall, the most serious type, indicating that continued use without correction could lead to serious injury or death. This correction involves modifying devices rather than removing them from use.