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The U.S. Food and Drug Administration (FDA) has updated the Ventilator Correction: Philips Issues Correction for Trilogy Evo Platform Ventilators recall communication as Philips has clarified the reasons for the recall and provided updated guidance on nebulizer use for affected customers.
In a letter sent to users on April 24, Philips provided updated guidance on the use of nebulizers with Trilogy Evo Ventilators. This update states that non-pneumatic nebulizers may be used as long as they are placed in accordance with the guidance and instructions on the proper location for a nebulizer on the various types of patient circuits. This recommendation replaced the firm’s previous recommendation to not use non-pneumatic nebulizers with the subject device.
As of May 27, Philips has not reported any additional serious injuries or deaths related to these issues. Previously, the firm reported three serious injuries associated with these issues.
This recall involves correcting devices and does not involve removing them from where they are used or sold. The FDA has identified this recall as the most serious type. This device may cause serious injury or death if you continue to use it without correction.
Questions?
DME and Homecare Customers in the U.S. with adverse reactions, quality problems, or questions about this recall should contact Philips at 1-800-345-6443, press option 2 for repair and then option 1. Hospital customers in the U.S. with adverse reactions, quality problems, or questions about this recall should contact Philips at 1 (800) 722-9377, press option 2.
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