FDA Device recall Z-0296-2025
LifeVent EVO2. Model Number: SP2100X26B. Intended for invasive and non-invasive ventilation of pediatric through adult patients weighing at…
- FDA Device
- Class I
- ongoing
- Published 2024-11-20
On 2024-11-20 the FDA classified a Class I recall of LifeVent EVO2. Model Number: SP2100X26B. Intended for invasive and non-invasive ventilation of pediatric through adult patients weighing at… by Philips Respironics, citing potential for in-line nebulizer configuration in certain locations to result in aerosol deposit accumulation on the device's internal flow sensor, which could lead to inaccurate f….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0296-2025 |
| Classification | Class I |
| Status | ongoing |
| Initiated | 2024-10-07 |
| Published | 2024-11-20 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Philips Respironics |
| Distribution | US |
Product
LifeVent EVO2. Model Number: SP2100X26B. Intended for invasive and non-invasive ventilation of pediatric through adult patients weighing at least 2.5 kg in institutional, home, and non-emergency transport settings.
Reason
Potential for in-line nebulizer configuration in certain locations to result in aerosol deposit accumulation on the device's internal flow sensor, which could lead to inaccurate flow measurements.
Identifiers
| code_info | Model No. SP2100X26B; UDI-DI: 606959057456; All Serial Numbers. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0296-2025%22
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