Philips Respironics Trilogy Evo Ventilator Software Update Addresses Safety Issues
Philips Respironics is issuing a mandatory software update (Version 1.05.10.00) for Trilogy Evo ventilators worldwide to resolve identified safety issues. Users must apply the update and review the updated User Manual.
The agency’s classification
FDA (Devices): Class I
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.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: FDA Class I medical device recall. Class I classification mandates a minimum severity of 4. No reported deaths or serious injuries are mentioned in the source text.
Plain-English summary
Philips Respironics, Inc. is recalling the Trilogy Evo ventilator and regional variants, including models distributed in the United States and numerous countries worldwide.
The recall addresses safety issues that were identified in earlier recalls. The manufacturer has released a mandatory software update (Version 1.05.10.00) and a User Manual addendum to resolve these issues.
Users of affected Trilogy Evo ventilators should apply the mandatory software update Version 1.05.10.00 and review the User Manual addendum provided by the manufacturer. Additional information about specific affected serial numbers and model variants is available through the FDA recall notice.
The recalled product
- Product
- Trilogy Evo; Model No./Model Description -- AU2110X15B Trilogy Evo, Australia BL2110X15B Trilogy Evo, Benelux BR2110X18B Trilogy Evo, Brazil CA2110X12B Trilogy Evo, Canada DE2100X13B Trilogy Evo O2, Germany DE2110X13B Trilogy Evo, Germany DS2100X11B Trilogy Evo, O2…
- Manufacturer
- Philips Respironics, Inc.
- Hazard
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 (20)
- Model Description/ UDI-DI-- Trilogy Evo
- Australia 606959051980
- Trilogy Evo
- Benelux 606959055520
- Brazil 606959055476
- Canada 606959052307
- Trilogy Evo O2
- Germany 606959054103
- Germany 606959054110
- O2
- USA 606959051997
- USA 606959051942
- Eastern Europe 606959055698
- Eastern Europe 606959055544
- Iberia 606959054097
- Iberia 606959054080
- EU 606959055674
- EU (Non-BT) 606959055681
- EU 606959054981
- EU (Non-BT) 606959055537
Distribution
Part of a larger recall action
This product is one of 3 recalled by Philips Respironics, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 3 products in this recall →Related recalls
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