Philips Respironics, Inc.: Medical Device Recall in 2024 - (Recall #: Z-1504-2024)

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

Class I

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

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.

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.

Voluntary: Firm initiated