FDA Device recall Z-1616-2026
Philips Respironics Trilogy EV300, Software Version 1.05.15.00
- FDA Device
- Class I
- ongoing
- Published 2026-04-01
On 2026-04-01 the FDA classified a Class I recall of Philips Respironics Trilogy EV300, Software Version 1.05.15.00 by Philips Respironics, citing 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1616-2026 |
| Classification | Class I |
| Status | ongoing |
| Initiated | 2026-03-02 |
| Published | 2026-04-01 |
| Last updated | 2026-09-13 11:58 UTC |
| Company | Philips Respironics |
| Distribution | US |
Product
Philips Respironics Trilogy EV300, Software Version 1.05.15.00. Continuous home-use ventilator device.
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.
Identifiers
| code_info | All Model No.; All UDI; All Serial No. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:58 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1616-2026%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.