Trilogy Evo Ventilator Software Update for Identified Safety Issues
Philips Respironics is issuing a mandatory software update (Version 1.05.10.00) for the Trilogy Evo Universal Ventilator to address safety issues identified in earlier recalls. Affected units should implement the update.
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 5/5 (Critical).
Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.
Our severity reasoning: This is an FDA Class I medical device recall. Per the severity rubric, FDA Class I recalls receive a Critical classification, as the agency has determined the defect poses a serious hazard to health or safety.
Plain-English summary
Philips Respironics has released a mandatory software update, Version 1.05.10.00, for the Trilogy Evo Universal Ventilator (Model DS2000X11B). The update, along with a User Manual addendum, addresses safety issues that were identified in earlier recalls of this ventilator model.
The affected devices include approximately 90,910 units distributed in the United States and 56,273 units distributed internationally across multiple countries. Healthcare providers, home healthcare agencies, and individual patients using this ventilator model should implement the mandatory update.
Facilities and users should contact Philips Respironics or their authorized distributor for guidance on installing the software update and accessing the accompanying User Manual addendum. Prompt implementation of the update is important to address the previously identified safety concerns.
The recalled product
- Product
- Trilogy Evo Universal Ventilator, Model No. DS2000X11B
- Manufacturer
- Philips Respironics, Inc.
- Hazard
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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Similar recalls
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