Philips Respironics, Inc. recalls LifeVent EVO2. Model Number: SP2100X26B. Intended for invasive and non-invasive ventilation of pediatric through adult…

Recall date

October 7, 2024

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0296-2025

FDA classification

Class I

Brand / firm

Philips Respironics, Inc.

Sold / distributed

Worldwide distribution - US Nationwide and the countries of AE, AF, AR, AT, AU, BD, BE, BG, BH, BO, BR, BS, CA, CH, CL, CN, CO, CZ, DE, DK, DZ, EC, EE, EG, ES, FI, FR, GB, GE, GF, GI, GR, GT, HK, HR, HU, ID, IE, IL, IN, IT, JE, JO, JP, KE, KR, KW, LB, LT, LY, MA, ME, MK, MM, MQ, MT, MX, MY, NG, NL,…

Why it was recalled

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.

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What was recalled

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.