[pending] Philips Respironics Trilogy Evo, Software Version 1.05.15.00. Continuous home-use ventilator device.
Pending LLM rewrite. Source: FDA_DEVICE Z-1646-2026.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Pending LLM scoring against the rubric.
Plain-English summary
In some situations, the Obstruction Alarm does not trigger within the timeframe dictated by the relevant standards and may take up to four breaths.
The recalled product
- Product
- Philips Respironics Trilogy Evo, Software Version 1.05.15.00. Continuous home-use ventilator device.
- Manufacturer
- Philips Respironics, Inc.
- Category
- Medical Device — Devices
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 (3)
- All Model No.
- All UDI
- All Serial No.
Distribution
Distributed nationwide across the United States.
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