Trilogy Evo EV300 Ventilator Mandatory Software Update for Safety Issues
Philips Respironics is issuing a mandatory software update (Version 1.05.10.00) for Trilogy Evo EV300 ventilators to resolve previously identified safety issues. Approximately 90,910 US units and 56,273 international units are affected.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: FDA Class I classification requires a minimum severity score of 4. The mandatory nature of the safety-critical software update reflects serious underlying concerns, though no deaths or serious injuries are explicitly mentioned in this source.
Plain-English summary
Philips Respironics, Inc. has released a mandatory software update (Version 1.05.10.00) and a User Manual addendum for the Trilogy Evo EV300 ventilator. This update is intended to address safety issues that were identified in earlier recalls of this ventilator model.
The Trilogy Evo EV300 is distributed worldwide. Approximately 90,910 units are present in the US, and 56,273 units are distributed in international markets across more than 40 countries. The ventilator is available in multiple regional variants, including versions for the US, Canada, Brazil, Europe, Asia, Africa, and other regions.
The specific safety issues being resolved by these updates were previously identified in earlier recall actions. The firm has made the software update and the updated User Manual addendum available to address these identified concerns. Users of the affected Trilogy Evo EV300 ventilators should implement the mandatory software update and review the updated User Manual addendum.
The recalled product
- Product
- Trilogy Evo EV300 -- Model Number/ Model Description: BL2200X15B Trilogy Evo, O2, Benelux EV300; BR2200X18B Trilogy Evo, O2, Brazil EV300; CA2200X12B Trilogy Evo, O2, Canada EV300; DE2200X13B Trilogy Evo, O2, Germany EV300; DS2200X11B Trilogy Evo, O2, USA EV300; DS2200X11B
- Manufacturer
- Philips Respironics, Inc.
- Category
- Medical Device — Ventilator
- Hazard
- software-malfunction
- ventilator-malfunction
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (19)
- Model / UDI-DI: Trilogy Evo
- O2
- Benelux EV300 606959058668
- Trilogy Evo
- Brazil EV300 606959058583
- Canada EV300 606959052321
- Germany EV300 606959058651
- USA EV300 606959052017
- Eastern Europe EV300 606959058705
- Spain EV300 606959058644
- EU EV300 606959058682
- France EV300 606959058613
- INT EV300 606959061033
- Great Britain EV300 606959058675
- INTL EV300 606959056497
- Italy EV300 606959058637
- Korea EV300 606959058590
- Nordics EV300 606959058620
- Turkey EV300 606959058798
Distribution
Distributed nationwide across the United States.
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