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Philips Respironics, Inc. recalls Trilogy Evo Universal Portable Electric Ventilator, Model Number DS2000X11B
Recalled April 12, 2023 · FDA recall Z-1289-2023 · Philips Respironics
Hazard
The accuracy of delivered oxygen may deviate below the required tolerance of 5% from setpoint when providing high concentration oxygen therapy. Additionally, if equipped, the internal FiO2 sensor may indicate a value higher than the device is actually delivering. This may lead to under delivery of oxygen. · FDA Class I
Units
62826 total devices
Sold at
Worldwide distribution. US Nationwide including Puerto Rico, and countries of AE, AR, AT, AU, BD, BE, BG, BO, BR, CA, CH, CL, CN, CO, CZ, DE, DK, EC, EE, EG, ES, FI, FR, GB, GE, GT, HK, HR, HU, ID, IL, IE, IN, IT, JP, KW, LB, LT, MM, MQ, MX, MY, NG, NL, NO, NP, NZ, PE, PF, PH, PK, PL, PT, QA, RO, RS, RU, SA, SG, SI, SK, TH, TR, TW, UA, VN, and ZA.
Description
The accuracy of delivered oxygen may deviate below the required tolerance of 5% from setpoint when providing high concentration oxygen therapy. Additionally, if equipped, the internal FiO2 sensor may indicate a value higher than the device is actually delivering. This may lead to under delivery of oxygen.
Product
Trilogy Evo Universal Portable Electric Ventilator, Model Number DS2000X11B
Manufacturer(s)
Philips Respironics, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →