Philips Respironics, Inc.: Trilogy Evo Universal Ventilator, all software versions except 1.05.06.00. Ventilator for pediatric and adult patients.

Hazard

Potential for sudden loss of ventilation due to Battery Depleted or Loss of Power alarm while unit has sufficient power.

Details from the source

Reason for recall: Potential for sudden loss of ventilation due to Battery Depleted or Loss of Power alarm while unit has sufficient power. Distribution: 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, Quantity: 9,999 units Lot/code info: Model No. DS2000X11B; UDI-DI: 606959052000; All units except those with software version 1.05.06.00.

UPC codes

606959052000

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.