Recall Z-1646-2026 ยท CBK Ventilator, Continuous, Facility Use
Philips Respironics, Inc.
Philips Respironics Trilogy Evo, Software Version 1.05.15.00. Continuous home-use ventilator device.
| Date | Apr 2, 2026 (initiated Mar 2, 2026) |
| Status | Open, Classified |
| Reason | In some situations, the Obstruction Alarm does not trigger within the timeframe dictated by the relevant standards and may take up to four breaths. |
| Root cause | Software design |
| Action | An IMPORTANT PRODUCT NOTICE was mailed to consignees 6/5/24 about obstruction alarm compliance failure in Trilogy Evo devices. Refer to the most current version of the IFU in the event of an obstruction. A software update to correct this issue is pending. An UPDATED: URGENT FIELD SAFETY NOTICE was mailed 3/2/26 with recall information for three failure modes possible in all Trilogy Evo, Trilogy EVO O2, Trilogy Evo Universal, and Trilogy EV300. Using non-pneumatic nebulizers with Trilogy Evo Platform ventilators may result in a discrepancy between the set tidal volume and the tidal volume recei |
| Quantity | 113,717 units |
| Distribution | Worldwide Distribution. US Nationwide, 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, Spain, Finland, France, Georgia, Fr |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K181166 | Trilogy Evo Respironics, Inc., Jul 18, 2019 |