Philips Respironics Trilogy Evo Universal, Software Version 1.05.15.00. Continuous home-use ventilator device.
Recall
- Recall Number
- Z-1649-2026
- Event Number
- 98540
- Firm
- Philips Respironics, Inc.
- FEI Number
- 2518422
- Product Code
- CBK
- Status
- Open, Classified
- Root Cause
- Software design
- Initiated
- March 2, 2026
- Posted
- April 2, 2026
- Address
- 1001 Murry Ridge Ln, Murrysville, PA, 15668-8517
Description
Philips Respironics Trilogy Evo Universal, Software Version 1.05.15.00. Continuous home-use ventilator device.
In some situations, the Obstruction Alarm does not trigger within the timeframe dictated by the relevant standards and may take up to four breaths.
An IMPORTANT PRODUCT NOTICE dated 6/5/24 was mailed to consignees containing information of an obstruction alarm compliance failure in Trilogy Evo devices. This notice instructed consignees to refer to the most current version of the IFU in the event of an obstruction. The notice informed consignees that a software update to correct this issue was pending. An UPDATED: URGENT FIELD SAFETY NOTICE dated 3/2/26 was mailed to consignees containing recall information for three different failure modes that can be experienced in all Trilogy Evo, Trilogy EVO O2, Trilogy Evo Universal, and Trilogy EV300 devices. The firm identified that using non-pneumatic nebulizers with Trilogy Evo Platform ventilators may result in a discrepancy between the set tidal volume and the tidal volume received by the patient. This can lead to under-delivery of therapy to the patient. Consignees are being instructed to update all devices with software version 1.05.15.00 through the My Philips for Professionals and InCenter websites. The provided Appendix B contains the required instructions. Consignees are also instructed to review the latest version of the User Manual Addendum, communicate the safety notice to all in their organization who interact with affect devices, and forward the notice to those who received product that was further distributed. Consignees are to stop all use of non-pneumatic nebulizers, including vibrating mesh nebulizers, with all affected devices. Distributors should notify their customers of this recall with the provided notice and response form. DME and Homecare Customers can contact 1-800-345-6443 (option 2, option 1) for assistance. Hospital Customers can contact 1-800-722-9377 (option 2) for assistance.
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113,717 units