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Philips Respironics, Inc. recalls Trilogy EV300, all software versions except 1.05.06.00. Ventilator for pediatric and adult patients.
Recalled April 24, 2024 · FDA recall Z-1502-2024 · Philips Respironics
Hazard
Potential for sudden loss of ventilation due to Battery Depleted or Loss of Power alarm while unit has sufficient power. · FDA Class I
Units
56,012 units
Sold at
Domestic: Nationwide Distribution; Foreign: AE, AR, AT, AU, BD, BE, BG, 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, MA, ME, MK, MM, MQ, MT, MX, MY, NG, NL, NO, NP, NZ, OM, PA, PE, PF, PH, PK, PL, PR, PT, PY, QA, RE, RO, RS, RU, SA, SE, SG, SI, SK, TH, TN, TR, TW, UA, US, UY, VN, YT, ZA, ZW.
Description
Potential for sudden loss of ventilation due to Battery Depleted or Loss of Power alarm while unit has sufficient power.
Product
Trilogy EV300, all software versions except 1.05.06.00. Ventilator for pediatric and adult patients.
Manufacturer(s)
Philips Respironics, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →