Recall Z-1617-2026 ยท CBK Ventilator, Continuous, Facility Use
Philips Respironics, Inc.
Philips Respironics Trilogy Evo Universal, Software Version 1.05.15.00. Continuous home-use ventilator device.
| Date | Mar 26, 2026 (initiated Mar 2, 2026) |
| Status | Open, Classified |
| Reason | 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. |
| Root cause | Under Investigation by firm |
| Action | 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 thro |
| Quantity | 113717 |
| Distribution | Worldwide distribution: US (Nationwide) and OUS (Foreign) to countries of: Argentina, Austria, Australia, Bosnia and Herzegovina, Bangladesh, Belgium, Bulgaria, Bolivia, Brazil, Bahamas, Canada, Switzerland, Chile, China, Colombia, Czech Republic, Germany, Denmark, Algeria, Ecuador, Estonia, Egypt, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K181170 | Trilogy Evo Universal Respironics, Inc., Jul 18, 2019 |