FDA-Device2023-04-12Class I
Trilogy Evo Universal Portable Electric Ventilator, Model Number DS2000X11B
Philips Respironics, Inc.
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.
Sold states
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.
Affected count
62826 total devices
Manufactured in
1001 Murry Ridge Ln, Murrysville, PA, United States
Products
Trilogy Evo Universal Portable Electric Ventilator, Model Number DS2000X11B
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1289-2023Don't want to check this manually?
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