Trilogy Evo, all software versions except 1.05.06.00. Ventilator for pediatric and adult patients.

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

Code information: Model No. AU2110X15B, BL2110X15B, BL2200X15B, BR2110X18B, BR2200X18B, CA2110X12B, CA2200X12B, DE2100X13B, DE2110X13B, DE2200X13B, DS2000X11B, DS2100X11B, DS2110X11B, DS2200X11B, EE2100X15B, EE2110X15B, EE2200X15B, ES2100X15B, ES2110X15B, ES2200X15B, EU2100X15B, EU2100X19, EU2110X15B, EU2110X19, EU2200X15B, FR2100X14B, FR2110X14B, FR2200X14B, FX2100X15B, FX2200X15B, GB2110X15B, GB2200X15B, IA2100X15B, IA2110X15B, IN2100X15B, IN2100X19, IN2110X15B, IN2200X15B, IT2100X21B, IT2110X21B, IT2200X21B, JP2100X16B, JP2110X16B, KR2110X15B, KR2200X15B, LA2100X15B, LA2110X15B, LD2110X23B, ND2100X15B, ND2110X15B, ND2200X15B, RDS2110X11B, SP2100X26B, TR2110X15B, TR2200X15B, UDS2110X11B, VT2110X24B; UDI-DI: 606959051980, 606959055520, 606959055476, 606959052307, 606959054110, 606959051942, 606959055544, 606959054080, 606959054981, 606959055537, 606959055506, 606959054127, 606959055490, 606959051959, 606959055421, 606959051973, 606959055483, 606959055452, 606959055513, 606959060517, 606959055551, 606959060500; All units except those with software version 1.05.06.00.

Distribution pattern: 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.