medical Class I Updated 2024-11-20

Philips Respironics, Inc. recalls LifeVent EVO2. Model Number: SP2100X26B. Intended for invas

Recalled 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.


Hazard / Issue

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.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Model No. SP2100X26B; UDI-DI: 606959057456; All Serial Numbers.
View official government recall

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