FDA Device recall Z-1646-2026
Philips Respironics Trilogy Evo, Software Version 1.05.15.00
- FDA Device
- Class I
- ongoing
- Published 2026-04-08
On 2026-04-08 the FDA classified a Class I recall of Philips Respironics Trilogy Evo, Software Version 1.05.15.00 by Philips Respironics, citing in some situations, the Obstruction Alarm does not trigger within the timeframe dictated by the relevant standards and may take up to four breaths.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1646-2026 |
| Classification | Class I |
| Status | ongoing |
| Initiated | 2026-03-02 |
| Published | 2026-04-08 |
| Last updated | 2026-09-13 11:58 UTC |
| Company | Philips Respironics |
| Distribution | US |
Product
Philips Respironics Trilogy Evo, Software Version 1.05.15.00. Continuous home-use ventilator device.
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.
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-1646-2026%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.