Philips Respironics recalls Trilogy Evo Universal ventilators with software version 1.05.15.00 due to potential tidal volume mismatch when using non-pneumatic nebulizers. Affected units may require software update or device check.
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.
“Philips Respironics Trilogy Evo Ventilator Software Issue: Tidal Volume Discrepancy Risk.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/49846-philips-respironics-trilogy-evo-ventilator-software-issue-tidal-volume-discrepancy. Based on FDA recall #Z-1617-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1617-2026%22&limit=1).
The FDA announced on March 2, 2026, that Philips Respironics is recalling its Trilogy Evo Universal continuous home-use ventilator devices. The recall affects all units due to a hazard involving non-pneumatic nebulizers.
How to tell if you have it
Brand: Philips Respironics
Product: Trilogy Evo Universal
Software Version: 1.05.15.00
Type: Continuous home-use ventilator device
Quantity: 113,717 units
The hazard
Using non-pneumatic nebulizers with the Trilogy Evo Platform ventilators may result in a discrepancy between the set tidal volume and the tidal volume received by the patient. The FDA's MAUDE database contains six reports naming the Trilogy Evo since March 2025, five of which were marked serious.
Context
GovInfoNow's records show Philips Respironics has issued 25 other recalls since June 12, 2018. Recent brand recalls include a Trilogy EV300 ventilator software update risk on March 2, 2026, and a SimplyGo Mini battery kit recall on October 7, 2025. Other recent recalls of similar products include the Philips Cardiac Workstation 7000 (July 1, 2026), the Philips Cardiac Workstation 5000 (July 1, 2026), and the Medline Intubation Tray (December 24, 2025).
How to tell if you have this one
Check for the model name 'Trilogy Evo Universal' and software version 1.05.15.00 on the device. All units with this software version are affected regardless of serial number or UDI.
Brand
Philips Respironics
Category
Medical device
FDA recall event · 4 products
All 4 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
Classification
Class I
Status
Ongoing
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, Spain, Finland, France, Georgia, French Guiana, Gibraltar, Greece, Guatemala, Hong Kong, Croatia, Hungary, Indonesia, Ireland, Israel, India, Italy, Jersey, Jordan, Japan, Kenya, South Korea, Kuwait, Lebanon, Lithuania, Morocco, Montenegro, North Macedonia, Myanmar, Martinique, Malta, Mexico, Malaysia, Nigeria, Netherlands, Norway, Nepal, New Zealand, Oman, Panama, Peru, French Polynesia, Philippines, Pakistan, Poland, Portugal, Paraguay, Qatar, R¿union, Romania, Serbia, Russia, Saudi Arabia, Sweden, Singapore, Slovenia, Slovakia, Thailand, Tunisia, Turkey, Taiwan, Ukraine, United Arab Emirates, United Kingdom, Vietnam, Mayotte, South Africa, Zimbabwe.
Recall number
Product, codes & lots
Quantity
Z-1614-2026
Philips Respironics Trilogy Evo, Software Version 1.05.15.00. Continuous home-use ventilator device.; All Model No.; All UDI; All Serial No.
113,717 units
Z-1615-2026
Philips Respironics Trilogy Evo O2, Software Version 1.05.15.00. Continuous home-use ventilator device.; All Model No.; All UDI; All Serial No.
113,717 units
Z-1616-2026
Philips Respironics Trilogy EV300, Software Version 1.05.15.00. Continuous home-use ventilator device.; All Model No.; All UDI; All Serial No.
113,717 units
Z-1617-2026
Philips Respironics Trilogy Evo Universal, Software Version 1.05.15.00. Continuous home-use ventilator device.; All Model No.; All UDI; All Serial No.
113717
Based on the official FDA remedy
What to do — step by step
Check Software Version
Verify the software version on your device; if it's 1.05.15.00, it's affected.
Contact Manufacturer
Reach out to Philips Respironics for guidance on correcting the software issue or potential device adjustments.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
Nationwide
Not listed
FDA 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…” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA published this recall 30 days after the firm started it.
1Firm started the recall
2FDA classified it Class I
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
Do I need to stop using my ventilator immediately?
No, the recall does not require immediate discontinuation. Affected users should check the software version and contact Philips Respironics for next steps.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-1617-2026 (March 2, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1617-2026 to see it in context.
Plain-language summary written by qwen3:4b on August 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.