Trilogy EV300, 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. BL2200X15B, BR2200X18B, CA2200X12B, EE2200X15B, EU2100X15B, EU2100X19, EU2200X15B, FR2200X14B, DE2200X13B, GB2200X15B, FX2100X15B, FX2200X15B, IN2100X15B, IN2100X19, IN2200X15B, IT2200X21B, JP2100X16B, KR2200X15B, LA2100X15B, ND2200X15B, ES2200X15B, TR2200X15B, DS2100X11B, DS2200X11B, UDI-DI: 606959058668, 606959058583, 606959052321, 606959058705, 606959055674, 606959055681, 606959058682, 606959058613, 606959058651, 606959058675, 606959061019, 606959061033, 606959054059, 606959055575, 606959056497, 606959058637, 606959055582, 606959058590, 606959055599, 606959058620, 606959058644, 606959058798, 606959051997, 606959052017; 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.