Food, drugs, devices › Philips Respironics, Inc.
Device recall: Philips Respironics Trilogy Evo, Software Version 1.05.15.00. Continuous home-use ventilator device.
FDA enforcement event 98540 is a device recall by Philips Respironics, Inc. of Murrysville, PA, initiated 2 Mar 2026 and classified Class I, with 4 product records.
FDA defines Class I as a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. 12% of the 572 device enforcement events initiated in 2026 carry the same class.
Status: Ongoing. Initiation: voluntary: firm initiated. Philips Respironics, Inc. has 26 enforcement events on this register, with a median of 3 product records per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Philips Respironics, Inc., Murrysville, PA.
Reason for recall
"In some situations, the Obstruction Alarm does not trigger within the timeframe dictated by the relevant standards and may take up to four breaths."
Distribution
"Worldwide Distribution. US Nationwide, Argentina, Austria, Australia, Bosnia and Herzegovina, Bangladesh, Belgium, Bulgaria, Bolivia, Brazil, Bahamas, Canada, Switzerland, Chile, China, Colombia,…"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-1646-2026 | Philips Respironics Trilogy Evo, Software Version 1.05.15.00. Continuous home-use ventilator device. | 113,717 units | Class I | Ongoing | 8 Apr 2026 |
| Z-1647-2026 | Philips Respironics Trilogy Evo O2, Software Version 1.05.15.00. Continuous home-use ventilator device. | 113,717 units | Class I | Ongoing | 8 Apr 2026 |
| Z-1648-2026 | Philips Respironics Trilogy EV300, Software Version 1.05.15.00. Continuous home-use ventilator device. | 113,717 units | Class I | Ongoing | 8 Apr 2026 |
| Z-1649-2026 | Philips Respironics Trilogy Evo Universal, Software Version 1.05.15.00. Continuous home-use ventilator device. | 113,717 units | Class I | Ongoing | 8 Apr 2026 |
Context
Other enforcement events for Philips Respironics, Inc.
All 26 events for Philips Respironics, Inc.
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "In some situations, the Obstruction Alarm does not trigger within the timeframe dictated by the relevant standards and may take up to four breaths."
What does Class I mean?
FDA classifies recalls by relative degree of health hazard. Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
Where was the product distributed?
FDA's distribution pattern field reads: "Worldwide Distribution. US Nationwide, Argentina, Austria, Australia, Bosnia and Herzegovina, Bangladesh, Belgium, Bulgaria, Bolivia, Brazil, Bahamas, Canada, Switzerland, Chile, China, Colombia,…"
Is the recall still ongoing?
FDA lists the status as Ongoing. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.