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.
What this means for you
Highest-severity recall. Risk of serious injury or death is documented or strongly suspected. 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
- software-defect
Distribution
Distributed nationwide across the United States.
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