Aeris EVO, all software versions except 1.05.06.00. Ventilator for pediatric and adult patients. (sold outside US)

Recall details

Manufacturer

Philips Respironics, Inc.

Distributor

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.

Lot

Model No. VT2110X24B, UDI-DI: 606959062962; Serial No. H31910535835D, H319109655846, H31911031E07F, H319110396C37, H3191306384A3, H3191532256B4, H319155872AB0, H3191570317EC, H3191583620EE, H31915891A921, H319159299B1D, H319160784DFF, H3191618894EB, H31917208A9F4, H319172300FD4, H3191724627EA, H319173454FAD, H319173602BB0, H3191737746D7, H31917540CED9, H319176335E2E, H31918356D617, H31918495C129, H319253137099, H31944263406E, H319491766AF0, H319502655CF0, H319502789ECD, H31950286F47B, H31950695BC59, H319506968EC2, H319507598549, H319507702B38, H319508223C55, H31950848C7DF, H319533300AF4, H3195359313C6, H31955839F509, H319560669049, H3196026450B5, H3199019010C1, H320660725F64, H3206652309E8, H3207128762DC, H321543394922, H32154494E3B2, H3215453113B3, H321545625F90, H321546048112, H321546538B15, H322135798ED7, H32255152065F, H32256310D258, H32256407333A, H322564225727, H322564243211, H322564342BC9, H32256459A4FC, H322564711B04, H32256479974C, H32256483BBDE, H32256494D6B9, H32256495C730, H322565045B7D, H32256515532C, H3225652468CD, H32259990DD1B, H322675076891, H32267615BD3F, H322676168FA4, H322676179E2D, H32267620C0FA, H32267621D173, H32267622E3E8, H32267623F261, H322676284CB2, H32267631C8AB, H32267632FA30, H322676349F06, H32267636BC14, H322678169FBF, H32267836AC0F, H3226784919F0, H32267875F9F4, H3226788648A7, H32267898B801, H32267911B1DC, H32267946BBDB, H322680579D6D, H322700498357, H322700646B02, H322701344F66, H322701514C1B, H322701706E22, H32270198787A, H3227019969F3, H32274200BEA2, H32274211B6F3, H322742208D12, H322742458E6F, H3227425597B7, H32274300E47E, H322744161495, H32274497CBDC, H32274501232E, H322745332A54, H3227454276D5, H32274588702F, H322746593EBA, H32275999C166, H3227600565C1, H322760102BB4, H322760113A3D, H32276013192F, H322760146D90, H3227602001DC, H322760345E20, H32276040550C, H322760441328, H32276057386B, H3227606245AE, H322760635427, H32276068EAF4, H322760761A52, H32276091F4FD, H32276092C666, H32276351B239, H32276400510D, H322764137A4E, H322764513E3C, H322764531D2E, H322765011A58, H3227650228C3, H322766974712, H32276698BFE5, H322772081727, H32277213B02C, H322782868260, H322782897A97, H32278357794D, H32365086B338, H323651150C67, H323651172F75, H32373232E4D2, H323732509310, H32373362C0B6, H323734277C7E, H3237344728AE, H3237345620FF, H32373482D6A3, H32373496895F, H323735053600, H32373562166F, H32373581BEE4, H3238101545EF, H323810543306, H32383924DB66, H323841003F11, H3239379062B5, H32393840980A, H324020510797, H35743993EBF5, H35744025A154, H3574403972E0, H357452125680, H3574524339B1, H357452612913, H357453537AB5, H357453642462, H3574563317D8, H3574563572EE, H35745648E403, H35745651601A, H35745658FDDB, H357456650C56, H357502274E56, H357502627E9B, H357508327359, H3575090203ED, H357509130BBC, H357509147F03, H3575092544E2, H35750959C386, H357509717C7E, H35751004E67E, H35751014FFA6, H3575106691BC, H35751128457E, H3575224723F0, H35771166DDE8, H35797327349B, H35797729BE84, H3579775539E0, H357977662113, H35797767309A, H357977727EEF, H35807882DB0D, H358079053BAE, H358079272B0C, H3580807449C8, H358080918475, H35808168C0A0, H3580818490DC, H3581092220C4, H35810925547B, H358109277769, H358109301A0E, H358109345C2A, H35810941468F, H358109504EDE, H358109551973, H358109642292, H35810965331B, H3581097709D1, H35810992C46C, H35811023B1E8, H35811032B9B9, H35811039076A, H35811043E538, H35811054885F, H35811074BBEF, H35811075AA66, H358110861B35, H3581109244C9, H35811099FA1A, H35811100EA1F, H35816239E5F3, H3581624307A1, H35816259B123, H35816349F227, H358163614DDF, H35816678F07B, H35816784E303, H35816791AD76, H35817021D960, H358170639D12, H358171281E7D, H35817146A3D3, H35828491F19C, H358288749982, H35828931F393, H3582907660E9, H358291199612, H3582926825F7, H35829301B63A, H35829372C9A9, H358333765867, H3583337749EE, H35833378B119, H3583339395DA, H35833394E165, H35833395F0EC, H358333993A80, H35833400FC5C, H35833405ABF1, H35840628E30D, H358406334406, H35840648B7DD, H3594407292F1, H35944133BEC4, H35944153EA14, H35944171FAB6, H359441860DC1,

Risk classification

Class I

Area (FDA)

device

Country

United States