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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 94263

7 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
March 19, 2024
Product types
Device
Classifications
Class I
Statuses
Ongoing
Recalling firm wording
Philips Respironics, Inc.

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

7 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 7

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

Z-1499-2024
Recall number
Z-1499-2024
Initiated
March 19, 2024
Classification
Class I
Status
Ongoing
Recalling firm
Philips Respironics, Inc.
Quantity
775 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential for sudden loss of ventilation due to Battery Depleted or Loss of Power alarm while unit has sufficient power.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code information

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, H359462171D42, H3594625448B9, H359462756A80, H359462982B75, H35946317479E, H359463451A34, H35946375305C, H35946429088D, H35946472C8E6, H3594659319A3, H35946649E9E5, H35946679C38D, H35946719CD81, H35946738EFB8, H359468346F13, H359468453392, H359468507DE7, H359468614606, H359468740873, H35946898580F, H35946992AD89, H359470369678, H35947050A79E, H359470619C7F, H35947077E091, H35947112B930, H359471393453, H359480523675, H35948086C029, H359481752BA6, H35948221FC5E, H35948272B07D, H35948373FB28, H359484375669, H359485005262, H359485027170, H35948604FB22, H80006991C0BE, H80007035FB4F, H80007144FD12, H80007161990F, H80007162AB94, H800071977FF1, H800072003332, H800072635579, H800076005053, H80007608DC1B, H80007609CD92, H800076115802, H800076137B10, H80008207F574, H800082091C0A, H80008211899A, H80008212BB01, H80008215CFBE, H80008217ECAC, H80008225E5D6, H80008226D74D, H80013443C9B8, H80013463FA08, H32305706CA65, H32305708231B, H32305725CB4E, H32305761EA0A, H32307263C9D3, H32307388B7CC, H32307468A1D9, H32307481A608, H3230760840B1, H323076529153, H32307666FD1F, H323076901BE1, H32324298C78D, H32324306A337, H32324320F5B1, H323293645F7A, H32329515D522, H323295937ED4, H3232960165BA, H323296025721, H32329639C39A, H3232966203F1, H3232968836BB, H32329748C5C7, H32329783D2B4, H32329912043E, H323299332607, H32340862D111, H32340918699F, H323411868D80, H323411897577, H323525060EA8, H32352612BE30, H32352751B117, H32352785474B, H3235283832C1, H323529048819, H32354139F4CC, H32354141358C, H3235414573A8, H323541521ECF, H323541547BF9, H323541808DA5, H3235948479B3, H3235952189B2, H32359534C7C7, H32359547B854, H323596512BDE, H3235965308CC, H32359658B61F, H32359660103F, H323596698DFE, H323596808A2F, H32361331BEA7, H323613759FE3, H32361398DE16, H3236141675AD, H323614256D5E, H323614534560, H323647292601, H323647486358, H323800220783, H32380634ADB4, H3238074788FB, H32380798C074, H32380859329A, H323809008B3F, H32380903B9A4, H3238092834C7, H3238095690B1, H323809963911, H323835627C93, H32383569C240, H323837449FAD, H323837807029, H32383852A984, H323839594D8B, H35743608C8F9, H357439460C20, H357439534255, H35743968D6EE, H35744017A82E, H35744035B88C, H35744065C634, H35744112A55F, H35744113B4D6, H35744117F2F2, H35744121BDAC, H3574413296EF, H35744141E97C, H35744150E12D, H35744167BFFA, H35744177A622, H357441926B9F, H357452205FFA, H357452250857, H35745235118F, H35745255455F, H35745269A55B, H357452764474, H35745285F527, H357453074229, H357453131DD5, H35745325528B, H35745341407F, H35745425DE8E, H357454584863, H357501965413, H35750253457A, H3575027155D8, H35750297AAFE, H357503343FC9, H35750560D18C, H35750608E670, H357506205988, H357507175D83, H357507405784, H357507878A9B, H3575081063FB, H357508467875, H357509013176, H35751024D5CE, H35751161BFDF, H357511792A4F, H35752242745D, H35752249CA8E, H357578399AAB, H357578735291, H357579070361, H35771189BF0F, H35771384D152, H3577140859FB, H357716170D6C, H3577164335F0, H35779310A5B6, H357794255476, H35789688ADA7, H35790052967B, H3579122363F9, H35791290B5CA, H35791315767B, H35791358CAFE, H35791383C455, H35791406D13D, H35791436FB55, H35791443E1F0, H357914559D1E, H35791508629F, H35791527A9D8, H357916737E20, H35810985A90B, H358264648BBB, H35826795F69E, H35826884B408, H35827002C587, H358271390BE0, H358333171D3E, H35838880572A, H358541835503, H35856003F869, H35856047D92D, H35856113BB6D, H35856140F74E, H35856189C32F, H35856237219D, H35856297DCED, H3585652486DB, H358566321551, H35856807788F, H358568132773, H358568265AB6, H358568884EB8, H35857020E5F9, H35947946476E, H359485666384, H35962890B023, H359677324AD1, H35970172A70D, H359752225886, H359753089EB0, H359832422D30, H35984017E6BC, H35984030A1B3, H359842113632, H35984230140B, H35984284B687, H3598430247AD, H3598431709D8, H359843326DC5, H359843499E1E, H359843720AA5, H35984467C8D5, H35984484605E, H359845083E2E, H35984532BB1C, H3598463345F1, H359846633B49, H359847055073, H3598472125E7, H35985111C5ED, H35985133D54F, H35985147DE63, H35985172A3A6, H359851998765, H35985226745E, H359852541A44, H359852706FD0, H35985415BA74, H359854385221, H3598552900AC, H80002784EC3C, H800069570C28, H80006958F4DF, H80006959E556, H8000696052FF, H800069740D03, H800069994CF6, H80007005D127, H80007012BC40, H80007013ADC9, H80007014D976, H80007015C8FF, H80007016FA64, H80007025E297, H80007026D00C, H80007031BD6B, H800070328FF0, H80007140BB36, H80007141AABF, H8000714926F7, H80007150A2EE, H80007151B367, H80007155F543, H80007183200D, H800071889EDE, H800071955CE3, H800072725D28, H800072734CA1, H800072761B0C, H80007454DD77, H80007461A0B2, H80007465E696, H800074683D73, H80007535C2F2, H800075449E73, H80007550C18F, H80007588FDBF, H800075971C90, H80007599F5EE, H8000760141DA, H8000760362C8, H8000760507FE, H8000760724EC, H80007610498B, H800076151E26, H800079948BA8, H80007997B933, H800082109813, H80008213AA88, H80008216FD25, H80008218145B, H8000821905D2, H800082229169, H80008224F45F, H80008227C6C4, H800082283E33, H800082292FBA, H800132225A38, H800132252E87, H800132335269, H800132413C73, H800132565114, H800132632CD1, H800132676AF5, H800132689202, H80013271161B, H80013448776B, H80013453D060, H80013455B556, H80013466ADA5, H8001361121AA, H800136210BC2, H800136267F7D, H800136300393, H800136333108, H800136426D89, H800136462BAD, H800136505743, H8001365146CA, H800136616CA2, H80014520A20E, H80014598CAEE, H800146363184, H80014637200D, H80014638D8FA, H80014639C973, H8001464019BA, H800146410833, H800146423AA8, H800146432B21, H800146445F9E, H800146454E17, H800146467C8C, H800146476D05, H8001472017B6, H80015088F630, H8001509240B2, H800151187BF4, H80015122FEC6, H80015127A96B, H80015130C40C, H80015132E71E, H80015146EC32, H80015148054C, H8001564998C0, H80015669AB70, H8001573677E3, H800157617DE4, H800157752218, H800157761083, H80015778F9FD, H80015780F67D, H80015783C4E6, H80015790EFA5, H80015791FE2C, H80015806174C, H80015808FE32, H800158106BA2, H8001581248B0, H800158153C0F, H800158171F1D, H80015819F663, H8001582041CA, H800158555B6F, H80015879A2B3, H800162563F43, H80016258D63D, H800162616194, H800162634286, H8001626527B0, H80016271784C, H800163034C8A, H8001631067C9, H80016387C46E, H800163883C99, H80016390A909, H800163928A1B, H800163939B92, H80016394EF2D, H80016395FEA4, H80016397DDB6, H800163982541, H80016400F214, H80016420C1A4, H80017557BE74, H80017563D238, H8001759717D4, H80017603698C, H800176063E21, H800176072FA8, H80017608D75F, H80017817266B, H80017829E57D, H800178360452, H800191432CAB, H800191445814, H800191476A8F, H800191489278, H8001914983F1, H8001915007E8, H800191602D80, H800191613C09, H800191646BA4, H8001916648B6, H80019174727C, H80019179A999, H800192108FEC, H8001921803A4, H800192293845, H80019377F55F, H80019386671E, H800193954C5D, H8001939897B8, H80019408CCA5, H800194503E55, H80019458B21D, H80019459A394, H800194744BC1, H3190942600E5, H31925239B6AF, H319252406666, H31925254399A, H31925261445F, H31925265027B, H31925294903A, H319252994BDF, H319253919D4B, H31925392AFD0, H31925422C77D, H3194051596B9, H3194082760BC, H319409401A0F, H319409631B24, H31940981A226, H319410385BEA, H319410394A63, H31941107D3A9, H319411853E7B, H3194221523CA, H3194222509A2, H319423660685, H31942410A2BE, H31942428049E, H31942451D457, H3194274564CF, H31948905CF1A, H319536032BBA, H319537766BC3, H3195381675D4, H3195581369E3, H3195584025C0, H319558413449, H31955843175B, H31956102D861, H31956105ACDE, H319561069E45, H319409467F39, H31955845726D, H322564565C0B, H3227604721B3, H32365121602B.

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.

device · product 2 of 7

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

Z-1500-2024
Recall number
Z-1500-2024
Initiated
March 19, 2024
Classification
Class I
Status
Ongoing
Recalling firm
Philips Respironics, Inc.
Quantity
1,233 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential for sudden loss of ventilation due to Battery Depleted or Loss of Power alarm while unit has sufficient power.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code information

Model No. LD2110X23B, UDI-DI: 606959057432; Serial No. H252356907DD7, H2612106781C2, H261387955F3A, H261571963219, H2619203865AC, H27144085F2DA, H2981485410EF, H29814870657B, H299104069E21, H2991072461E7, H2991911756AE, H29924135D04F, H299272315CC2, H2993291565E3, H2993303190D2, H29936459457C, H299366416554, H31909781664E, H319121138FCC, H31915513BB8C, H3191553299B5, H31944077AA2A, H32107059F10F, H32259997A9A4, H32260005251F, H322744746357, H247407147A36, H25233095B739, H31943269B815, H32106647CBCB, H322783721D50, H32305876CDAA, H32338749C3B1, H32338792CD1A, H3233886753B8, H32338887C9A8, H323389735698, H32339112C9B8, H32339122E3D0, H32339188B1FA, H323392032E8D, H32340206B09F, H32340265D6D4, H32340266E44F, H3234028986A8, H3234033938DC, H3234047519D5, H323405754309, H3234066796A7, H32340689E5C9, H32340720DFA4, H3234078022D4, H323407857579, H323408860D25, H3234091680E1, H32340920CFBF, H3234092843F7, H32340936B351, H32340937A2D8, H32341039CB03, H323410566724, H32341085E5C7, H3234109827FA, H3234110137FF, H323411563DF8, H32342253A0FC, H32348004C3ED, H32352346BF11, H32352363DB0C, H323524606592, H32352655ADEF, H32352731E5C7, H323528496E40, H32352851FBD0, H323528827933, H3235288368BA, H323529194A24, H3235292698BB, H32354143169E, H323541446221, H323541667283, H323541698A74, H32354185DA08, H32359489A256, H32359514F477, H32359586007D, H3235960402CB, H32359609D92E, H32359618D17F, H32359628FB17, H323596306E87, H32359648AFC7, H323596556DFA, H323596565F61, H323596667509, H323596755E4A, H32361320B6F6, H323613569EC8, H32361365863B, H323613815A0F, H3236139360C5, H3236149589F6, H323651234339, H323651689A8A, H323733494DD5, H32373468E3E9, H323735125B67, H323735236086, H323735362EF3, H32373603BC52, H32373604C8ED, H323736080281, H32373612B403, H32373617E3AE, H323736837292, H32373713FF56, H323738794E1B, H323739158A7B, H3237405437AD, H323764137E65, H3237647985EF, H32376487EF59, H323765212DC3, H323765561474, H32376569C6EB, H32376577364D, H32376591C96B, H32376632E9E4, H32376724CFD6, H32376815BEF0, H323768248511, H32381020382A, H32381029A5EB, H3238103467D6, H323810406CFA, H32381049F13B, H3238107400B6, H32384038C3ED, H323937778C1A, H32393793502E, H32393799FF74, H32731689D902, H327393041042, H32739793D084, H327398016E49, H3273981531B5, H3273983055A8, H327398445E84, H32739856644E, H327398883D48, H32739891B951, H327399771CAB, H327399886794, H327400124A77, H327400500E05, H32741331B883, H327413468134, H327413587192, H32741377BAD5, H32741389D063, H3274145071DF, H3274147736D0, H327414884DEF, H327414895C66, H32741518C02B, H327415502B03, H327415745E97, H327416861129, H327417249597, H32741725841E, H32807068EF9D, H32807193885A, H328082175D23, H3280836569E5, H32809514FF06, H32809522B058, H328095934579, H32809599EA23, H328096062AA8, H3280963246E4, H32809638E9BE, H328096457F53, H328096521234, H32809662385C, H328096676FF1, H328096777629, H328096909886, H328265543C17, H32826956BAA6, H3283578725C5, H800011478413, H800011487CE4, H80001158653C, H8000115974B5, H80001170DAC4, H80007192285C, H8000720122BB, H800075769709, H800075960D19, H800133133B05, H80013319945F, H80013329BE37, H800133407726, H800133443102, H800133461210, H80013566F779, H800135690F8E, H80013572A885, H800135791656, H80017784892F, H323083317C5C, H323094483C2B, H323096035020, H32309624172F, H3230964443FF, H3230965981C2, H32309714679B, H323097332094, H323097624FA5, H32309791FEF6, H323098226202, H3230986752CF, H32310323A80A, H32310332A05B, H32310347BAFE, H323384582484, H323386554AD9, H323389201ABB, H32338949D3AA, H323390594AD7, H32339070E4A6, H3233912486E6, H32339146F124, H323391519C43, H32339187490D, H32339196415C, H32340217B8CE, H3234022792A6, H323402810AE0, H3234031096AD, H32340312B5BF, H323404145C8C, H32342334DA4F, H32354161063C, H323596547C73, H32361314DABA, H32361337DB91, H323613468710, H323614055EEE, H32376750C4FA, H32380937D5E8, H3238098266ED, H32381071571B, H3238406566B0, H32384108B359, H32731276C15C, H32731352EE14, H327314030D20, H327314288043, H32731478FEFB, H32731590B27F, H32731706B5E9, H32731766E139, H327317790016, H327318180F88, H327318659965, H32731912FA0E, H32731954F858, H327399112D4D, H3283571197EB, H357878041752, H35787829FF07, H357893268014, H35789362A150, H3578950332D0, H357895313BAA, H357895424439, H357895471394, H35789705E25E, H3578994484AC, H3579124889FA, H357913345442, H357914139F48, H357914697D1A, H357914906313, H35791564FC23, H35791577D760, H35791607750C, H357916364EED, H357916525C19, H357917798BA6, H35791787E110, H35826218DA06, H35826304536E, H358263312EAB, H35826390C252, H358264081507, H3582642826B7, H358264836514, H35826751191A, H358267712AAA, H35826842789E, H3582685515F9, H35826967465F, H35828265E2A9, H3582829036CC, H35828334D744, H3582846240CF, H358284635146, H358284707A05, H358284725917, H358284743C21, H35828483CB56, H35828495B7B8, H358285241845, H3582854229A3, H35828569A4C0, H35828595ED64, H35828612B87F, H35828662F577, H35828696309B, H35828757D26E, H358333327923, H35833344511D, H358333454094, H35833346720F, H358333489B71, H358333498AF8, H358333500EE1, H358333511F68, H358333522DF3, H358333533C7A, H3583335448C5, H35833355594C, H358333566BD7, H358333577A5E, H3583335882A9, H358333599320, H358333602489, H358333613500, H35833362079B, H358333631612, H3583336641BF, H358333675036, H35833368A8C1, H35833369B948, H358333703D51, H358333712CD8, H358333721E43, H358333730FCA, H358333747B75, H358333756AFC, H8000718454B2, H80007185453B, H800071898F57, H800071911AC7, H8000719339D5, H80007205649F, H80007209AEF3, H800072102AEA, H800072131871, H800072164FDC, H800072200082, H800072233219, H8000722446A6, H800072288CCA, H80007309F42F, H80007574B41B, H8000758437D3, H80007589EC36, H800075953F82, H800133155E33, H8001342823BB, H80013434F00F, H80013437C294, H80013440FB23, H80013564D46B, H800135708B97, H80013580085F, H8001358119D6, H80013683D5A0, H80013684A11F, H800136886B73, H80013692DDF1, H8001369872AB, H800136996322, H800137007327, H8001370162AE, H8001370341BC, H80013709EEE6, H8001522211A2, H80015223002B, H800156764A5F, H80015678A321, H80015685FB0C, H80015687D81E, H80015858808A, H80015887C805, H800159064D90, H800159165448, H800162473712, H800162572ECA, H80017598EF23, H800176005B17, H800176027805, H8001761042CF, H8001778952CA, H80017790D6D3, H80017792F5C1, H800178004B0C, H358264469B19, H35828734B425, H80001153DBEF, H80001154AF50, H800071279B59, H80007146DE00, H80007147CF89, H80007148377E, H800071539075, H80007156C7D8, H800071876629, H800072157D47, H800072222390, H80007225572F, H8000722665B4, H80007227743D, H800072716FB3, H800072770A85, H80007278F272, H8000731342AD, H800073161500, H800073170489, H80007318FC7E, H80007375734B, H800075679F58, H800075787E77, H8000758071F7, H80007583436C, H80007585265A, H800075935AB4, H8001332646C0, H800133303A2E, H80013345208B, H80013419185A, H80013441EAAA, H80013442D831, H80013567E6F0, H800135719A1E, H80013574CDB3, H80013577FF28, H800135833AC4, H800135844E7B, H800135888417, H80013671757A, H800137070798, H800150807A78, H80015082596A, H8001508348E3, H80015093513B, H80015097171F, H80015098EFE8, H80015099FE61, H80015100EE64, H8001510973A5, H80015113C527, H800152099CC1, H80015227460F, H8001570038BD, H800158142D86, H800158533E59, H800158613723, H8001586205B8, H800158675215, H800158712EFB, H80015881AD33, H8001589938A3, H800159031A3D, H80015910317E, H80016249DE6C, H800162505A75, H800162550DD8, H80016259C7B4, H800162643639, H8001626704A2, H800163445F55, H800163454EDC, H800163577416, H800163599D68, H800163703319, H8001637564B4, H8001637747A6, H80016378BF51, H8001638293C3, H80016391B880, H80017594254F, H8001779490F7, H80017795817E, H800178051CA1, H800191262FD6, H80019315829D, H80019344EDAC, H80019347DF37, H800193493649, H80019350B250, H80019351A3D9, H80019354F474, H800193877697, H80019393296B, H800193945DD4, H800193976F4F, H2523313375A3, H25233139DAF9, H252331466F06, H25235209546F, H25235233D15D, H2523527084A6, H252353009372, H252353108AAA, H25235326C5F4, H252354246AE3, H25235432160D, H2523547360E4, H25235633B23C, H25235651C5FE, H25235661EF96, H25235714AFEF, H25390190D706, H25390192F414, H253901949122, H2539019580AB, H25390196B230, H258930334AD9, H25904803A41D, H25951953C87A, H2595196496AD, H259519658724, H25951972EA43, H259519927053, H2595199504EC, H259520233CA1, H25952068E512, H259578568E91, H260602753B30, H260652015E4B, H260722100A7F, H2607224074C7, H260796861B25, H260799385C34, H26079974F138, H260801082301, H2608422556DC, H260842606611, H260842707FC9, H260843882A95, H26084443B1E3, H261207405673, H26121060F57D, H261211179616, H26123458094A, H261236234F29, H261236261884, H26124134F96A, H26124141E3CF, H261261943D6C, H261262654049, H26126527883E, H261266121A9F, H261342577B01, H261342838D5D, H26138824E0DC, H261389800154, H261391144A11, H26149439AB25, H2615280525D3, H261567464803, H26156792BE5F, H261568507E2A, H261568740BBE, H261569235B65, H2615719146A6, H261572017EDA, H2616621431D8, H261662340268, H2616628283F6, H26166317599F, H261663540C64, H261920278483, H261920529E26, H26192112A39A, H261921392EF9, H26194259DED7, H26194278FCEE, H261943304D1A, H26194387DD0D, H261974287142, H261975496EC7, H26202133DCBA, H26206229F7B0, H2620623073A9, H262067042658, H26206878EBFB, H26206984F883, H26207068285A, H2620722255D8, H262073023CB4, H262073076B19, H2620733035CE, H26859082BC08, H268616034D8C, H268617514AFA, H26861760711B, H268620950CB6, H27148229E74A, H271482306353, H27148348F8CF, H27148566F4D8, H27148881E508, H27149005B795, H27149152E74E, H2726818706D5, H2981442923A1, H298146707560, H29814681E721, H29814692CC62, H29814693DDEB, H29814694A954, H29814728DD4C, H29814729CCC5, H2981474005D4, H2981475768B3, H2981475981CD, H298147603664, H298147757811, H298147764A8A, H298147775B03, H29814778A3F4, H298148075CCC, H298148462A25, H298148473BAC, H29814859CB0A, H298148625FB1, H29814890FF6B, H29814908FEE7, H298149160E41, H29814918E73F, H298149237384, H2981492516B2, H298149522F05, H29814962056D, H29815011FA5B, H29815013D949, H29815033EAF9, H29907774433A, H2990782303FA, H299080314D0B, H29908191EAA7, H29910321552B, H2991033729C5, H29910524D45F, H299106207D1F, H2991064029CF, H29910662396D, H299109516B59, H299109848C8C, H299122984FE8, H299123141198, H29912401D3E8, H299124149D9D, H29912434AE2D, H29912457C866, H299124690B70, H299124800CA1, H299124989931, H299127897E04, H29923218805F, H299233040937, H299233150166, H29923318DA83, H299233610A4A, H299236372879, H2992377536D7, H299237886EFA, H29923793C9F1, H2992379966AB, H29923991FAF8, H29924026A1D0, H299240874D29, H2992409577E3, H299241218FB3, H299241281272, H29924149572B, H299241594EF3, H29924180634A, H299272236608, H299286861D4D, H299328237061, H2993286640AC, H299329607F46, H299329753133, H29933021890A, H29936414F9F9, H299364696F14, H299364934386, H29936501ED50, H29936547EF06, H2993664257CF, H299529736F9D, H2999576432F0, H3161220521CF, H31910077FE92, H319110900C86, H31913187024B, H319158060A86, H31917422E3C7, H31917423F24E, H319174295D14, H31917456E8EB, H31917474F849, H3191749573D0, H319175391E10, H319176700BD5, H31918301DC10, H31918311C5C8, H31918422513E, H319184530DBF, H319184755B39, H319185067E76, H31918529B531, H319186812B6D, H319186946518, H31918722BE5A, H3192027310C2, H31920896AE05, H319209521B5D, H319209645403, H31920979963E, H31920997E550, H31921011CE03, H31921027815D, H319210379885, H3192103971FB, H319210428220, H31921150E236, H319211568700, H31925396E9F4, H31949070551A, H31989591900E, H31989627FEF4, H319898687178, H3199221995D2, H31992246139D, H319922626609, H3199231637F9, H319923420F65, H31992359A86E, H31992441B1FB, H319925239CE5, H31992536D290, H319925586F3E, H31992571C14F, H319926765A94, H31992680BC6A, H319926993873, H319927165498, H31993941523F, H31994071B368, H31994116C9DB, H31994139029C, H32000207807B, H320004046439, H32000623968E, H32066235F903, H32066806928A, H320668693EAD, H32066972C37A, H32066973D2F3, H320670344189, H32070661E220, H32070821955B, H320708697E73, H32106388A321, H32106389B2A8, H3210664922B5, H321066977BB3, H32106771DE49, H3210682877F7, H32106917FFB4, H321069758876, H321070023164, H321070045452, H32107109D56B, H32154274AF7B, H32154290734F, H32154299EE8E, H321545355597, H32154558DAA2, H321545616D0B, H32154569E143, H32154581F71B, H32154585B13F, H3215461498CA, H32154619432F, H32154622D794, H321546428344, H32154650B98E, H32154657CD31, H32180496CE38, H3218051568BF, H321805165A24, H321805174BAD, H3218052104F3, H321805322FB0, H32180644E8EA, H321807108AAA, H32180715DD07, H32180730B91A, H32182439F2C9, H32182653BCFB, H32182693155B, H321827183F94, H32182748412C, H32182776823A, H321827925E0E, H321828086C8B, H32182830CAAB, H32182913915C, H3218356274C5, H32183627AB6C, H321836518352, H32183738109F, H32183765B5C2, H321838394BD1, H322098432370, H32209860225B, H32209891B01A, H322099536074, H322126779476, H322127729907, H322128038F41, H32212804FBFE, H32212810A402, H32212898E68A, H32212954DF9A, H32212956FC88, H322129864CF0, H32213028D85B, H322135818157, H3225997510A6, H32259985936E, H32259993EF80, H3225999940DA, H322600034029, H32260009EF73, H322600106B6A, H322600124878, H32260019F6AB, H32260028CD4A, H322600314953, H322600341EFE, H322600350F77, H32267861A608, H32269962600D, H32274389B77F, H322744532458, H32274484E09F, H32274873B24B, H32274913BC47, H32276763D822, H322785129F59, H322842790497, H3228450149D2, H3228455026E3, H32284798B6B3, H322849078947, H322849490759, H322850153328, H32285018E8CD, H322851643575, H32286267CD47, H32286315F981, H32286324C260, H32286336F8AA, H32286362C036, H322863668612, H322866784F09, H3228732098FF, H3228743990E3, H32287721EA17, H322877428C5C, H32287812B823, H32340533415F, H32340863C098, H323411527BDC, H3235415658EB, H323541654018, H32354167630A, H32373317DA13, H323735499B0C, H323735702CA5, H327319719C45, H327319932547, H32732008F55F, H327320273E18, H327320620ED5, H327320765129, H32732119A7D2, H327321415522, H32732160771B, H327321760BF5, H32807182800B, H328071983689, H328082065572, H328082310BA5, H3280824365BF, H32808269F955, H328082707D4C, H328083665B7E, H32808377532F, H32808397C93F, H32809696FDB0, H32809917683E, H328099848DBD, H328099949465, H32814158B1A0, H328141601780, H32814183BF0B, H32815225D492, H32815242F4FD, H32815243E574, H3281525953F6, H32815260E45F, H32815270FD87, H3281527871CF, H3281529421B3, H328152971328, H32815300EA53, H32815303D8C8, H32815314B5AF, H32815323EB78, H328153249FC7, H32815337B484, H32815359092A, H32815370A75B, H32815389B952, H3281540354CD, H32815418F3C6, H3281542276F4, H80015136A13A, H80015143BB9F, H80015692966B, H800180131474, H247406117747, H252309795E96, H252356192ED6, H261343437E21, H26120669A2DE, H26123456E034, H2612367777B5, H261500826018, H26166239D98D, H2619436033A2, H298146266EEE, H299241907A92, H239876824C6F, H23987734972D, H25230916F2B1, H252331214F69, H2981465265C2, H298149124865, H298149171FC8, H2981506285C8, H2981508659FC, H29815101B95F, H29815106CDE0, H29815108249E, H29816474BF8A, H299109773DDF, H299526688251, H2995272210B7, H299528252ECF, H299528808412, H29952895CA67, H2995298498EA, H29953031AB4A, H29953044B1EF, H2995307851EB, H29953095101E, H299531158402, H2995319980AE, H29954218E7A2, H29954238D412, H299815692505, H299815793CDD, H2998158464F0, H299815912A85, H299957267682, H29995791E695, H299958775374, H29995919B406, H299959310BFE, H301401123FEA, H30140200EA44, H30146224D44A, H30146256BA50, H30146381244B, H31909528B347, H3190968759A4, H31909698B88B, H31909804B5E4, H31909820C070, H31909836BC9E, H31909857F9C7, H3190993192FD, H319099817655, H319099835547, H319099853071, H31910034AB69, H319100482C0D, H31910067E74A, H319106517ECD, H31910832089D, H31910869C8F6, H3191093343C8, H319110148462, H31911049213F, H3191105938E7, H3191108327C5, H3191116493B6, H319120931BD0, H31912122B42D, H31912124D11B, H31912125C092, H319121308EE7, H319121319F6E, H31912163C2C4, H3191216784E0, H319121779D38, H319121853DE2, H31913147ABEB, H31913162CFF6, H31915229B2BB, H319152416A23, H319152995613, H319153402176, H31915488889B, H31915558623F, H3191556959DE, H31915576B8F1, H3191559622E1, H3191568383F0, H31915685E6C6, H319157322C0D, H319157536954, H319158532393, H319158731023, H319159734AFF, H31916066BD59, H319172311E5D, H319172322CC6, H31917394EE5C, H319174865893, H3191758713C6, H319176105F05, H319176114E8C, H319176127C17, H3191762164E4, H31917622567F, H319176431326, H31917649BC7C, H319182805985, H31918386666F, H3191844205EE, H319185220BE2, H31918877DD88, H31918973C170, H31920883E070, H31920919C2EE, H3192095129C6, H319210681ECA, H31921115D2FB, H319211191897, H31921125F893, H31921133847D, H319211383AAE, H31921141EA67, H31921175862B, H319211904B96, H319211951C3B, H319252167DE8, H31925249FBA7, H31925476FFE1, H319254854EB2, H3194064050C8, H319406436253, H319406707AA0, H3194067259B2, H319408760F8D, H319408987CE3, H319410168124, H31941076D5F4, H31941115E963, H31941137F9C1, H319422477E60, H3194225544AA, H31942271313E, H31942287D7C0, H3194230305F8, H319423716BE2, H31942384BF87, H319423869C95, H3194248256B4, H31942531DA5B, H319426614B87, H319426884C56, H319429689C81, H31943034A8F0, H319430379A6B, H319430482F94, H31943062B37E, H31943065C7C1, H31943137C0B7, H31943154A6FC, H319431579467, H31943176B65E, H3194319158F1, H31943218E494, H31943227360B, H3194331746BF, H319433311039, H319434835B86, H31943530D769, H31943554C59D, H31943570B009, H3194358475E5, H319435931882, H31943627556A, H3194364701BA, H319436535E46, H3194367508C0, H319437015930, H31943739FF10, H319437632EF2, H31943794D985, H319438099FBF, H319438198667, H319438435785, H3194391150F3, H319439403FC2, H319439465AF4, H319439611DFB, H31944027D492, H31944052CE37, H31944133D1B2, H3194415294EB, H319441791988, H3194418441A5, H31944218B3B5, H31944282CBF7, H31944285BF48, H319443034E62, H31944318E969, H31944342388B, H31944410E924, H31948822D2C9, H31948823C340, H31948835BFAE, H31948902BBA5, H319489228815, H319489496216, H31948961DDEE, H31948973E724, H319489805677, H319490111043, H3194901222D8, H31949029B663, H31949086B3E4, H31949087A26D, H319490885A9A, H319491163E20, H319491360D90, H319507501888, H319508643E03, H31951152F1F8, H319532106398, H3195327126C1, H31953333386F, H31953500F645, H3195376106A4, H31960632285A, H319607454B31, H3196077653C2, H319607993125, H319608157F4E, H319608164DD5, H319609630DAC, H80013989303D, H8001399386BF, H80013994F200, H80013995E389, H80013996D112, H80013997C09B, H80013998386C, H8001399929E5, H80014000A803, H80014001B98A, H800140028B11, H80014006CD35, H80014007DCBC, H80014008244B, H80014011A052, H8001765025AF, H80017659B86E, H800176600FC7, H800176622CD5, H8001766449E3, H800177435430, H80017744208F, H80017746039D, H800177471214, H800177543957, H80017982FC02, H80017990C6C8, H80017996A3FE, H800179995B09, H800180003F37, H80018005689A, H800180065A01, H80018008B37F, H80018009A2F6, H8001801026EF, H80018018AAA7, H3194263024B6, H2981481031AB.

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.

device · product 3 of 7

LifeVentEVO2, all software versions except 1.05.06.00. Ventilator for pediatric and adult patients. (sold outside US)

Z-1501-2024
Recall number
Z-1501-2024
Initiated
March 19, 2024
Classification
Class I
Status
Ongoing
Recalling firm
Philips Respironics, Inc.
Quantity
1,002 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential for sudden loss of ventilation due to Battery Depleted or Loss of Power alarm while unit has sufficient power.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code information

Model No. SP2100X26B, UDI-DI: 606959057456; Serial No. H25691987749F, H25693118A4C4, H26260563C38D, H272315740BD0, H275461032A2A, H2754619843E1, H800113616C69, H8001868315B5, H80018684610A, H800186864218, H25960483860A, H25961937C742, H259841474367, H260431913B25, H262335860DA9, H262602020AD1, H262644950D43, H262646266EC8, H262646367710, H262646617D17, H263906254068, H2639077033A1, H26233895D995, H2623414968BE, H262563210770, H262563563EC7, H2626051921DF, H26261131E1FD, H26264428320E, H272679278F9E, H80017449140E, H26256349DFE8, H262563550C5C, H26264347122C, H26294981C73C, H26295055B1C5, H26295125A611, H2629623201DF, H262962357560, H262962641A51, H26345540BE52, H26375381CD6E, H2637608762F1, H263815582E1E, H263905899810, H2639068866FD, H2639071176F8, H2639071530DC, H26390733665A, H26687445E9E2, H27267903FA0A, H272680683EEE, H274533967E1F, H2745340372AF, H27455642FA64, H27455664ACE2, H27457409AF19, H274575466A52, H274575576203, H27457607F3DF, H27466494A293, H274664979008, H2746650178FA, H274665035BE8, H274674897C15, H274675106C10, H274675124F02, H274675135E8B, H2746751718AF, H274675204678, H2746761192FD, H274781970CB3, H27479224295F, H274793406177, H27479520E37E, H274795396767, H275437779988, H27543778617F, H2754377970F6, H275437806EFF, H275437817F76, H275437824DED, H275437835C64, H2754378428DB, H275437853952, H275437860BC9, H275437871A40, H27543788E2B7, H27543789F33E, H275437907727, H2754379166AE, H275437925435, H2754379345BC, H275437943103, H27543795208A, H275437961211, H275437970398, H27543798FB6F, H27543799EAE6, H275460360D33, H275460371CBA, H27546038E44D, H275460512D5C, H275460530E4E, H2754606016BD, H275460610734, H275460711EEC, H275460722C77, H27546083BE36, H27546086E99B, H2754609184FC, H27546095C2D8, H2754609908B4, H275461213A88, H275461220813, H275461330042, H275461416E58, H275461425CC3, H27546158EA41, H275461637EFA, H27546174139D, H275461750214, H27546180D671, H27546197BB16, H27551205FC1D, H275512093671, H275512183E20, H275512209800, H27551232A2CA, H27551242EFC2, H275512448AF4, H275512459B7D, H27551253E793, H2755125582A5, H27551262DC72, H27551270E6B8, H27551274A09C, H27551275B115, H27551276838E, H27551288E938, H27551289F8B1, H275512925FBA, H275512943A8C, H27551299E169, H27563102437C, H27563158929E, H27564230F243, H275644011F7B, H275710614DD9, H800109700BF9, H80011050B8EC, H80011063A01F, H80011067E63B, H800111684410, H80011219F7F5, H800112432617, H800112476033, H8001124898C4, H800112511CDD, H800112522E46, H800112544B70, H800113075D8F, H8001131030E8, H800113112161, H8001131213FA, H800113130273, H8001131476CC, H800113156745, H800113174457, H80011318BCA0, H80011319AD29, H800113210B09, H800113245CA4, H800113254D2D, H800113267FB6, H800113276E3F, H8001133112D1, H800113388F10, H800113572337, H80011395A985, H80011405F298, H25538574D9D9, H256917933B78, H2569193868C0, H2569196907F1, H256920522A99, H2569224829A3, H256924542CCE, H256925062BB8, H25692591881F, H25692661E4B3, H25692712C1FC, H25692910F2F5, H25692952B687, H256930400CE8, H2569421090C9, H256943094E0C, H25755370F165, H25755371E0EC, H25755372D277, H25769443EF6B, H2576945959E9, H2576949608BE, H25769512DA86, H25769515AE39, H257695178D2B, H257699654692, H25772204E13C, H259584118A14, H25958911756B, H25960632C693, H25960737CBE2, H25960998DE7E, H2596136923FE, H259617382FAE, H25983710C898, H25983775CBE5, H25984185C9D5, H25986483AC28, H260075998BF0, H2604304597A5, H260448537AA8, H260449630A1C, H26044994FD6B, H260796778964, H262337714F66, H262339077743, H262339471023, H26234040AFA3, H262352143E3C, H262352499B61, H26235410AEC1, H262356737D32, H262468417142, H262468884523, H2624688954AA, H26246934313B, H262469575770, H2624697101F6, H26246983A12C, H26247151E83F, H2624717957C7, H26247198DC5E, H262522230C52, H26252293E8FA, H2625229947A0, H26252319D3BC, H262523316C44, H262562712314, H2625627474B9, H262562774622, H26256278BED5, H26256280B155, H2625628383CE, H26256290A88D, H262562928B9F, H262562939A16, H2625630751F6, H262563121F83, H26256319A150, H262563311EA8, H262563344905, H2625633992E0, H262563451584, H262563514A78, H26259921C6F3, H2626014282D5, H26260162B165, H2626070547D3, H26260997A3C2, H26261014DF3C, H26261150A4A4, H262642611E76, H2626430664C5, H262643627631, H26264392F5F9, H26264453C1D5, H26264470C0FE, H26264521F513, H26264541A1C3, H262646244DDA, H262646472B91, H263906020767, H26390608A83D, H263906344839, H263906753ED0, H26390678E535, H263907016F20, H263907544635, H266873137E69, H26687344746E, H26687475C38A, H266875587103, H2668761164C6, H26687650122F, H26687781E902, H27230335B75B, H2723068658D5, H80009083D493, H800091025106, H800091061722, H8000910706AB, H80009108FE5C, H80009109EFD5, H800091106BCC, H800091117A45, H8000911248DE, H800091135957, H800091142DE8, H800091153C61, H800091160EFA, H800091171F73, H80009118E784, H80009119F60D, H8000912041A4, H80009121502D, H8000912262B6, H80009123733F, H800091240780, H800091251609, H80009128CDEC, H80009130587C, H800091327B6E, H800091336AE7, H80009138D434, H800091401574, H8000914104FD, H800091423666, H8000914327EF, H8000914542D9, H8000914761CB, H8000914988B5, H800091500CAC, H800091511D25, H800091522FBE, H800091939797, H800092009D70, H80009203AFEB, H8000920900B1, H8000921084A8, H800092119521, H80009212A7BA, H80009213B633, H8000921808E0, H800092191969, H80009220AEC0, H80009224E8E4, H800092904A68, H8000929378F3, H80009299D7A9, H80009300C7AC, H80009301D625, H80009302E4BE, H80009303F537, H800093048188, H800093059001, H80009306A29A, H80009307B313, H800093084BE4, H800093095A6D, H80009312FD66, H80009313ECEF, H800093149850, H8000931589D9, H80009316BB42, H80009318523C, H8000931943B5, H80009320F41C, H80009321E595, H80009322D70E, H80009323C687, H80009324B238, H80009332CED6, H80009335BA69, H8000933688F2, H80009337997B, H80009338618C, H800093397005, H80009340A0CC, H80009341B145, H8000934283DE, H800093439257, H80009344E6E8, H80009345F761, H800093690EBD, H80009376EF92, H8000937806EC, H8000938118E5, H800093844F48, H8000939010B4, H80009391013D, H8000939233A6, H800093954719, H800093967582, H80009397640B, H800093989CFC, H800094015A20, H80009483B7F2, H80009494DA95, H80009496F987, H80009497E80E, H8000949810F9, H800095045751, H8000950546D8, H800095067443, H8000950765CA, H800095098CB4, H8000951008AD, H800095111924, H800095122BBF, H800095133A36, H800095155F00, H800095166D9B, H800095177C12, H8000951884E5, H80009519956C, H800095535D56, H800095571B72, H80009597B2D2, H80009610E7C9, H80009637A0C6, H800096385831, H8000963949B8, H800096409971, H8000964188F8, H80009643ABEA, H80009645CEDC, H80009646FC47, H800096481539, H8000964904B0, H8000965080A9, H800096519120, H80009652A3BB, H80009653B232, H80009654C68D, H80009655D704, H80009656E59F, H80009657F416, H800096580CE1, H800096591D68, H80009660AAC1, H80009661BB48, H8000966289D3, H80009663985A, H80009664ECE5, H80009666CFF7, H80009667DE7E, H80009670B319, H80009672900B, H80009676D62F, H80009677C7A6, H800096783F51, H80009683024A, H8000968476F5, H80009685677C, H80009726F24B, H80009733BC3E, H80009736EB93, H8000973802ED, H800097391364, H80009741D224, H80009742E0BF, H80009743F136, H800097448589, H80009746A69B, H800097484FE5, H80009751CBFC, H80009752F967, H80009753E8EE, H800097549C51, H80009756BF43, H80009950CA6E, H800099559DC3, H800099584626, H80009963D29D, H80009964A622, H80009970F9DE, H80009974BFFA, H80009998EF86, H80009999FE0F, H80010000DAEF, H80010001CB66, H80010002F9FD, H80010003E874, H800100049CCB, H800100058D42, H80010007AE50, H80010009472E, H80010010C337, H80010013F1AC, H80010017B788, H800100184F7F, H800100195EF6, H80010020E95F, H80010021F8D6, H80010022CA4D, H80010023DBC4, H80010024AF7B, H80010025BEF2, H800100268C69, H80010030F087, H80010062AD2D, H80010067FA80, H80010073A57C, H80010112BAF9, H80010114DFCF, H80010116FCDD, H8001013398C0, H80010134EC7F, H80010140E753, H80010144A177, H80010145B0FE, H800101468265, H8001014793EC, H800101486B1B, H800101497A92, H80010150FE8B, H80010153CC10, H80010154B8AF, H80010155A926, H800101569BBD, H800101578A34, H8001015872C3, H80010159634A, H80010160D4E3, H80010161C56A, H80010162F7F1, H80010163E678, H8001016492C7, H80010165834E, H80010166B1D5, H80010167A05C, H8001016858AB, H80010170CD3B, H80010171DCB2, H80010172EE29, H80010173FFA0, H800101748B1F, H800101759A96, H80010176A80D, H80010177B984, H800101784173, H8001017950FA, H800101804EF3, H800101815F7A, H800101826DE1, H800101837C68, H8001018408D7, H800101873A4C, H80010188C2BB, H800102042973, H800102455F9A, H8001024995F6, H8001027310C4, H8001027575F2, H80010335484E, H80010390E293, H80010447AA51, H800104548112, H80010462CE4C, H80010463DFC5, H8001046799E1, H800104686116, H800104778039, H8001047878CE, H80010480774E, H8001048345D5, H80010513C811, H800105169FBC, H80010522F3F0, H80010523E279, H8001052496C6, H80010525874F, H80010526B5D4, H80010527A45D, H800105285CAA, H800105294D23, H80010530C93A, H80010531D8B3, H80010532EA28, H80010533FBA1, H800105348F1E, H800105359E97, H800105384572, H800105408432, H800105728D48, H800109105F29, H8001131655DE, H800113298741, H800154492D78, H80015451B8E8, H80015454EF45, H80015457DDDE, H80015463B192, H800155181895, H800155229DA7, H80015541FBEC, H80015542C977, H80015543D8FE, H80015545BDC8, H800155479EDA, H8001554977A4, H80015550F3BD, H800155578702, H800155587FF5, H800155658E78, H80015566BCE3, H80015567AD6A, H80015568559D, H800155694414, H80015570C00D, H80015571D184, H80015572E31F, H80015573F296, H800155748629, H80015576A53B, H80015577B4B2, H800155784C45, H800155795DCC, H8001558043C5, H80015581524C, H8001558260D7, H80015583715E, H8001558405E1, H800155851468, H80015588CF8D, H800155905A1D, H800155914B94, H8001561258AB, H800156152C14, H800156161E8F, H800156170F06, H80015618F7F1, H80015619E678, H8001562051D1, H800156214058, H8001562272C3, H80015623634A, H8001562417F5, H80015625067C, H80015627256E, H80015628DD99, H80015629CC10, H800156304809, H800156315980, H800156340E2D, H80015638C441, H80015639D5C8, H800159276FA9, H8001593002CE, H8001593221DC, H80016147D876, H8001620024CD, H800162013544, H8001620207DF, H800162031656, H8001620462E9, H800162057360, H8001620641FB, H800162075072, H80016208A885, H80016209B90C, H800162112C9C, H800162121E07, H800162130F8E, H800162147B31, H800162156AB8, H800162165823, H8001621749AA, H80016218B15D, H80016219A0D4, H80016220177D, H8001622106F4, H80016222346F, H80016501B941, H800168710B36, H800169011CE2, H800169198972, H800169274A64, H800169346127, H8001693570AE, H800169364235, H80016938AB4B, H80016939BAC2, H800169406A0B, H800169417B82, H800169424919, H800169435890, H800169442C2F, H800169453DA6, H800169460F3D, H80016948E643, H80016949F7CA, H8001695250C1, H800169534148, H80016957076C, H8001706944DF, H80017070C0C6, H80017071D14F, H80017072E3D4, H80017073F25D, H8001707486E2, H80017075976B, H80017077B479, H800170784C8E, H800170815287, H800170837195, H80017084052A, H80017088CF46, H800170905AD6, H80017106B224, H80017111DF43, H80017113FC51, H80017123D639, H80017124A286, H80017125B30F, H800171268194, H80017127901D, H8001712868EA, H800171297963, H80017130FD7A, H80017131ECF3, H80017132DE68, H80017133CFE1, H80017136984C, H8001713789C5, H800171429360, H8001714382E9, H80017144F656, H80017145E7DF, H80017146D544, H80017147C4CD, H800171492DB3, H80017150A9AA, H800171539B31, H80017157DD15, H80017159346B, H80017164C5E6, H80017165D46F, H80017166E6F4, H80017167F77D, H800171691E03, H80017172B908, H80017174DC3E, H80017175CDB7, H800171988C42, H800172157603, H800172367728, H8001723766A1, H8001725400EA, H800172551163, H8001725623F8, H80017258CA86, H80017259DB0F, H800172624FB4, H800172642A82, H80017281E73F, H800172878209, H80017290EF6E, H80017291FEE7, H80017292CC7C, H80017293DDF5, H80017294A94A, H800172968A58, H800172979BD1, H800172986326, H8001730062AA, H800173017323, H8001730241B8, H800173035031, H80017304248E, H800173053507, H80017306079C, H800173071615, H80017308EEE2, H80017309FF6B, H800173116AFB, H800173125860, H800173501C12, H80017453A28C, H80017455C7BA, H800174590DD6, H80017460BA7F, H80017461ABF6, H80017462996D, H80017464FC5B, H80017465EDD2, H80017466DF49, H80017467CEC0, H800174683637, H8001746927BE, H80017473913C, H800174921AA5, H800175128EB9, H80017514EB8F, H80018072512D, H80018139D242, H800181433010, H800181455526, H8001814667BD, H800181499F4A, H800181523841, H800181545D77, H800181554CFE, H800181576FEC, H80018158971B, H800181598692, H8001816120B2, H800181621229, H80018164771F, H800181656696, H80018166540D, H80018168BD73, H80018169ACFA, H80018171396A, H800181720BF1, H800181731A78, H800181746EC7, H800181764DD5, H800181775C5C, H80018178A4AB, H80018179B522, H80018181BAA2, H8001818399B0, H80018184ED0F, H800181882763, H8001818936EA, H80018190B2F3, H80018191A37A, H8001819291E1, H800181938068, H80018195E55E, H800181983EBB, H800181992F32, H800182008A8F, H80018202A99D, H8001820806C7, H80018209174E, H80018212B045, H80018254B213, H8001826589F2, H80018275902A, H800182784BCF, H80018284026B, H80018300D053, H8001830587FE, H800183085C1B, H800183094D92, H80018310C98B, H80018311D802, H80018313FB10, H800183159E26, H80018316ACBD, H80018317BD34, H8001831845C3, H80018320E3E3, H80018321F26A, H80018324A5C7, H80018325B44E, H8001832686D5, H80018327975C, H800183286FAB, H800183297E22, H80018330FA3B, H80018332D929, H80018333C8A0, H80018334BC1F, H80018335AD96, H800183369F0D, H800183378E84, H800183387673, H8001833967FA, H80018340B733, H80018341A6BA, H800183429421, H8001834385A8, H80018344F117, H80018345E09E, H80018374DB7F, H80018375CAF6, H80018376F86D, H80018377E9E4, H800183801E93, H8001843344A5, H800184352193, H800184403B36, H8001845022EE, H800184513367, H8001845201FC, H800184531075, H8001845464CA, H800184622B94, H800184633A1D, H800184644EA2, H800184655F2B, H800184666DB0, H800184677C39, H8001846884CE, H800184699547, H80018470115E, H8001847100D7, H80018472324C, H8001847323C5, H80018474577A, H8001847546F3, H800184767468, H8001847765E1, H800184789D16, H800184798C9F, H800184809296, H80018481831F, H80018482B184, H80018483A00D, H80018484D4B2, H80018485C53B, H80018486F7A0, H80018487E629, H800184881EDE, H800184890F57, H800184908B4E, H800184919AC7, H80018492A85C, H80018493B9D5, H80018494CD6A, H80018495DCE3, H80018496EE78, H80018497FFF1, H800184980706, H800185011703, H800185033411, H8001850440AE, H800185176BED, H800185198293, H80018538A0AA, H8001854061EA, H800185435371, H80018548EDA2, H80018630C386, H80018633F11D, H8001863485A2, H80018636A6B0, H80018637B739, H800186395E47, H800186408E8E, H800186419F07, H80018642AD9C, H80018643BC15, H80018644C8AA, H80018645D923, H80018646EBB8, H80018647FA31, H8001864802C6, H80018649134F, H800186509756, H8001865186DF, H80018652B444, H80018653A5CD, H80018654D172, H80018655C0FB, H80018656F260, H800186581B1E, H80018660BD3E, H80018661ACB7, H80018665EA93, H80018666D808, H80018667C981, H800186683176, H80018671B56F, H80018673967D, H80018675F34B, H80018677D059, H8001883495B9, H800188394E5C, H80018855D0E0, H80018856E27B, H800188591A8C, H80018860AD25, H80018861BCAC, H800188628E37, H800188639FBE, H80018864EB01, H80018865FA88, H80018866C813, H80018867D99A, H80018868216D, H80018871A574, H8001887297EF, H800188738666, H80018874F2D9, H80018875E350, H80018876D1CB, H8001887838B5, H80018879293C, H8001888126BC, H80018961E670, H800189696A38, H262606335251, H8000950100FC, H80017076A5F0, H800172887AFE, H80018322C0F1, H80018499168F.

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.

device · product 4 of 7

Trilogy EV300, all software versions except 1.05.06.00. Ventilator for pediatric and adult patients.

Z-1502-2024
Recall number
Z-1502-2024
Initiated
March 19, 2024
Classification
Class I
Status
Ongoing
Recalling firm
Philips Respironics, Inc.
Quantity
56,012 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential for sudden loss of ventilation due to Battery Depleted or Loss of Power alarm while unit has sufficient power.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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.

device · product 5 of 7

Trilogy Evo O2, all software versions except 1.05.06.00. Ventilator for pediatric and adult patients.

Z-1503-2024
Recall number
Z-1503-2024
Initiated
March 19, 2024
Classification
Class I
Status
Ongoing
Recalling firm
Philips Respironics, Inc.
Quantity
789 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential for sudden loss of ventilation due to Battery Depleted or Loss of Power alarm while unit has sufficient power.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code information

Model No. EE2100X15B, FR2100X14B, DE2100X13B, ES2100X15B, IA2100X15B, IT2100X21B, ND2100X15B; UDI-DI: 606959055698, 606959055643, 606959054103, 606959054097, 606959055636, 606959055438, 606959055650; Serial No. H800104584B7E, H80018230A0E7, H8001823283F5, H80018233927C, H800182382CAF, H2623419512AA, H800110158821, H8001102879AC, H80011056DDDA, H80011065C529, H800110719AD5, H80011102BF9A, H80011104DAAC, H800111090149, H80011113B7CB, H80011116E066, H262336530518, H262337246673, H2623372754E8, H800103367AD5, H80018963C562, H8001031758EC, H8001035379A8, H800104038B15, H80010417D4E9, H80010432B0F4, H800104595AF7, H80010471E50F, H80011463C37E, H80018944826D, H80018970EE21, H80010279BF9E, H80010286C4A1, H800102929B5D, H80010433A17D, H8001147975FC, H800169471EB4, H8001695073D3, H8001695435F7, H26233897FA87, H26201692998B, H80008934C421, H80008950D6D5, H8001095129C0, H80011047D58B, H800110493CF5, H800110538A77, H80011055EF41, H80011057CC53, H8001105834A4, H800110609284, H80011061830D, H80011064D4A0, H80011066F7B2, H80011106F9BE, H80011115D2FD, H80011117F1EF, H80018231B16E, H80018234E6C3, H80018236C5D1, H80018241FC66, H26234008448B, H26234104D43B, H262352828C12, H262338307348, H800111108550, H2747923076A3, H2746649868FF, H274792732358, H2747936052C7, H27479461CF4B, H23630215A1ED, H24371560D579, H24762461A009, H24762464F7A4, H255384963A07, H2578201604B2, H25782086D3AA, H25782201DC6D, H257930433A58, H257930444EE7, H257930510092, H2579305546B6, H2579306309E8, H257930665E45, H260429505975, H262563002549, H2625630134C0, H262563289AB1, H262563404229, H26260614155E, H26260629E4D3, H2626063060CA, H262608513588, H2626088909B8, H262608908DA1, H26260948EB4D, H262609650318, H262610840824, H262610936543, H26261102F90E, H26261153963F, H262611955AA9, H26264213706C, H262642447A6B, H26264295DB9A, H262643435408, H26295126948A, H262952013CE1, H2630989379EA, H263099095B74, H26309950B80D, H263099529B1F, H263456065360, H26345663501D, H263456878C29, H26376023D9A5, H263761109B8A, H26376141F4BB, H26376148697A, H26381224257F, H26381297F34C, H26381348E11F, H26381427C13D, H26381523DDC5, H2639063559B0, H26390684AC91, H263907423ADB, H263907566527, H26390791B838, H26436123B2B8, H26436132BAE9, H26436165B0EE, H264361807D53, H264442115D0C, H264442253140, H264442809B9D, H2646758207CF, H264676331D8A, H2646782643E4, H2646784706BD, H264678535941, H272300771C4D, H2723034821B6, H27230853AF1B, H272315751A59, H27231688AD10, H27267776F0B4, H27267816EEA3, H27267830B825, H27267900C891, H272679439D6A, H27267951A7A0, H27268002C564, H272680178B11, H272680348A3A, H27268045D6BB, H27268099ACAF, H23708996882F, H25958981A273, H259605245519, H259838090646, H26079674BBFF, H262014691128, H26201588C06D, H262017323E27, H26235313105F, H262468357A6E, H26256287C5EA, H26256353696A, H26259915AABF, H262602426DB1, H26260403CD81, H262607067548, H26260819DEA0, H262609000065, H2626092475F1, H2639064737AA, H26390649DED4, H27267965CBEC, H274664968181, H274665006973, H27467614C550, H27479283A090, H27479325620A, H274793751CB2, H2747939586A2, H274794181F82, H27479462FDD0, H2747946498E6, H274794950AA7, H274795297EBF, H27479618AA3A, H275460700F65, H27546098193D, H2754610894F9, H2754611110E0, H275461275FBE, H275461434D4A, H27546152451B, H27546154202D, H2754617276AB, H275461849055, H27546190CFA9, H27551225CFAD, H27551237F567, H27551243FE4B, H27551260FF60, H275512669A56, H2755126962A1, H27551300F16C, H27551304B748, H275513087D24, H2755992503D3, H27560078DE3F, H275600894C7E, H2756011728C4, H275601521809, H275601689D3B, H2756221917A8, H275622850ADC, H2756228729CE, H275623844189, H275623899A6C, H2756239549D8, H27562409D8A9, H2756242613EE, H275624700860, H27562482A8BA, H275625330747, H275625750511, H27562579CF7D, H275625894CB5, H27562591D925, H27562593FA37, H275625959F01, H27562866D12D, H275628683853, H275629769229, H2756297783A0, H275629906D0F, H275629917C86, H27563010236A, H2756304638E4, H2756421487D7, H275642429C59, H27564304C4D3, H27564331B916, H2756433824D7, H2756439055EF, H27564449F453, H27564450704A, H27564483F2A9, H27564485979F, H27570906ED13, H275710895B81, H27571148B974, H27573207F0F1, H275732905356, H275733429AE0, H27573346DCC4, H27573443076C, H27573483AECC, H27573487E8E8, H275734890196, H2757351674A5, H80010938E0D1, H80010939F158, H800109402191, H8001094644A7, H80010949BC50, H800109503849, H800109521B5B, H800109530AD2, H800109547E6D, H800109556FE4, H800109565D7F, H800109574CF6, H80010958B401, H80010959A588, H800109601221, H8001096103A8, H800109623133, H8001096320BA, H800109645405, H80010965458C, H800109667717, H80010967669E, H800109689E69, H800109698FE0, H800109711A70, H8001097228EB, H800109733962, H800109744DDD, H800109755C54, H800109766ECF, H800109777F46, H8001097887B1, H800109799638, H800109808831, H8001098199B8, H80010982AB23, H80010983BAAA, H80010984CE15, H80010985DF9C, H80010986ED07, H80010987FC8E, H800109880479, H8001098915F0, H8001099091E9, H80010992B2FB, H80010993A372, H80010994D7CD, H80010995C644, H80010996F4DF, H800109981DA1, H800109990C28, H80011000C654, H80011001D7DD, H80011002E546, H80011003F4CF, H8001100591F9, H80011006A362, H80011007B2EB, H800110084A1C, H800110095B95, H80011010DF8C, H80011011CE05, H80011012FC9E, H80011013ED17, H8001101499A8, H80011016BABA, H80011031FDB5, H80011044E710, H80011051A965, H800110681ECC, H800110690F45, H800110708B5C, H80011072A84E, H80011073B9C7, H80011074CD78, H80011076EE6A, H80011077FFE3, H800110780714, H80011079169D, H800110800894, H800110822B86, H800110833A0F, H800110844EB0, H800110855F39, H800110877C2B, H8001108884DC, H80011090114C, H8001109100C5, H8001109323D7, H800110945768, H8001109546E1, H8001109765F3, H800110998C8D, H800111018D01, H80011103AE13, H80011105CB25, H80011107E837, H8001110810C0, H8001111194D9, H80011114C374, H800111180918, H80011120AF38, H80011121BEB1, H800111228C2A, H800111239DA3, H80011124E91C, H80011125F895, H80011126CA0E, H80011127DB87, H800111282370, H80011130B6E0, H80011131A769, H8001113295F2, H80011133847B, H80011134F0C4, H80011135E14D, H80011136D3D6, H80011137C25F, H800111383AA8, H800111392B21, H80011140FBE8, H80011141EA61, H80011142D8FA, H80011143C973, H80011144BDCC, H80011145AC45, H800111469EDE, H800111478F57, H8001114877A0, H800111496629, H80011150E230, H80011151F3B9, H80011152C122, H80011153D0AB, H80011154A414, H80011155B59D, H800111568706, H80011157968F, H800111586E78, H800111597FF1, H80011160C858, H80011161D9D1, H80011162EB4A, H80011163FAC3, H800111648E7C, H800111659FF5, H80011166AD6E, H80011167BCE7, H800111695599, H80011170D180, H80011171C009, H80011172F292, H80011173E31B, H8001117497A4, H80011175862D, H80011176B4B6, H80011177A53F, H800111785DC8, H800111794C41, H800111805248, H8001118143C1, H80011182715A, H8001118360D3, H80011184146C, H8001118505E5, H8001118726F7, H80011188DE00, H80011189CF89, H800111904B90, H800111926882, H800111940DB4, H800111951C3D, H800111962EA6, H800111973F2F, H80011198C7D8, H80011199D651, H8001120073EC, H800112016265, H8001120250FE, H800112034177, H8001120435C8, H800112052441, H8001120616DA, H800112070753, H80011208FFA4, H80011209EE2D, H800112106A34, H800112117BBD, H800112124926, H8001121358AF, H800112142C10, H800112153D99, H800112160F02, H800112171E8B, H80011218E67C, H80011220405C, H8001122151D5, H80011222634E, H8001122372C7, H800112240678, H8001122734E3, H80011229DD9D, H800112305984, H80011231480D, H800112327A96, H800112336B1F, H800112341FA0, H800112363CB2, H80011238D5CC, H80011239C445, H80011240148C, H800112410505, H800112454321, H8001124671BA, H800112500D54, H800112533FCF, H800112555AF9, H800112566862, H80011258811C, H800112599095, H80011260273C, H8001126136B5, H80011262042E, H8001126315A7, H800112646118, H800112657091, H80011266420A, H800112675383, H80011268AB74, H80011269BAFD, H800112703EE4, H800112712F6D, H800112721DF6, H800112730C7F, H800112756949, H800112765BD2, H800112774A5B, H80011278B2AC, H80011279A325, H80011280BD2C, H80011281ACA5, H800112829E3E, H800112838FB7, H80011284FB08, H80011285EA81, H80011286D81A, H80011287C993, H800112883164, H8001128920ED, H80011290A4F4, H80011291B57D, H8001129287E6, H80011293966F, H80011294E2D0, H80011295F359, H80011296C1C2, H80011297D04B, H8001129828BC, H800112993935, H800113002930, H8001130138B9, H800113020A22, H800113031BAB, H800113046F14, H800113057E9D, H800113064C06, H80011308A578, H8001133331C3, H80011334457C, H80011336666E, H8001133777E7, H800113404E50, H800113415FD9, H800113426D42, H800113437CCB, H800113440874, H8001134519FD, H800113462B66, H800113473AEF, H80011348C218, H80011349D391, H800113505788, H800113514601, H80011352749A, H800113536513, H8001135411AC, H800113550025, H80011358DBC0, H80011359CA49, H800113607DE0, H800113625EF2, H800113634F7B, H800113643BC4, H800113652A4D, H8001136618D6, H80011367095F, H80011368F1A8, H80011369E021, H800113706438, H8001137175B1, H80011372472A, H8001137356A3, H80011374221C, H800113753395, H80011376010E, H800113771087, H80011379F9F9, H80011382C4E2, H80011383D56B, H80011384A1D4, H80011385B05D, H8001138682C6, H800113897A31, H80011390FE28, H80011391EFA1, H80011392DD3A, H80011393CCB3, H80011394B80C, H800113969B1E, H800113978A97, H800113987260, H8001139963E9, H80011400A535, H80011401B4BC, H800114028627, H8001140397AE, H80011404E311, H80011407D18A, H80011408297D, H8001140938F4, H80011410BCED, H80011411AD64, H800114129FFF, H800114138E76, H80011414FAC9, H80011415EB40, H80011416D9DB, H80011417C852, H80011419212C, H800114209685, H80011421870C, H80011422B597, H80011423A41E, H80011424D0A1, H80011425C128, H80011426F3B3, H80011427E23A, H800114281ACD, H800114290B44, H800114308F5D, H80011432AC4F, H80011433BDC6, H80011434C979, H80011435D8F0, H80011436EA6B, H80011437FBE2, H800114380315, H80011439129C, H80011440C255, H80011441D3DC, H80011442E147, H80011443F0CE, H800114448471, H8001144595F8, H80011446A763, H80011447B6EA, H800114484E1D, H800114495F94, H80011450DB8D, H80011451CA04, H80011453E916, H800114549DA9, H800114558C20, H80011456BEBB, H80011457AF32, H8001145857C5, H80011459464C, H80011460F1E5, H80011461E06C, H80011462D2F7, H80011464B7C1, H80011465A648, H8001146694D3, H80011467855A, H800114687DAD, H80011470E83D, H80011471F9B4, H80011472CB2F, H80011473DAA6, H80011474AE19, H80011475BF90, H800114779C82, H2578218798FF, H800112372D3B, H800113886BB8, H80011406C003, H8001141830A5, H257930757506, H25793048848B, H2579307201B9, H257930929BA9, H257930373174, H25793039D80A, H257930621861, H257930656CDE, H25793068B73B, H800111191891, H2604449376AB, H26294959FB0C, H263455889BBA, H27230660A7F3, H272316974C3F, H27551233B343, H27551241DD59, H25793056742D, H257930612AFA, H257930713322, H25793074648F, H26256295FF20, H2626099580D0, H26390708F2E1, H27231120502D, H27268044C732, H25787344D82B, H2578742046DA, H80011452F89F, H25781923C0A4, H800182927E85, H262962198CBC, H272311161F73, H257820401F3C, H257820445918, H2578730964AE, H25793041194A, H25793050111B, H257930532380, H25960485E33C, H262018544506, H263759152F28, H263905954BA4, H8001133554F5, H257816815401, H260427752D73, H263753524F8D, H24762460B180, H255386624A53, H25787261E6EA, H257930337750, H257930589D53, H25793085F6CE, H25787360ADBF, H24371562F66B, H236054105302, H23605538B626, H23677951D33E, H2370896428F5, H25781757DB93, H257818119302, H25781910D857, H25781954F913, H25781966F069, H25781967E1E0, H25781995413A, H26044695A625, H260449152222, H2604519353AD, H236305017214, H259611456F9A, H262563505BF1, H26256358D7B9, H26259933FC39, H262599846C2E, H262600659F06, H26260144E7E3, H26260342376D, H2626036642F9, H2626039939C6, H26260527E2C9, H263760184D1E, H23987674AA91, H260431628A76, H259590418B76, H2596048838D9, H2596106506F6, H262563130E0A, H262563232462, H262563333DBA, H26256346271F, H26260015D20E, H263098850504, H239876768983, H239876806F7D, H259615770581, H26019364A002, H2625630572E4, H262563572F4E, H26260564B732, H23605519941F, H262563473696, H2692580034DB, H27215215A6E8, H26925795FEA9, H26925794EF20, H26925790A904, H27039285F81A, H2703930218B9, H270392983A27, H270393047D8F, H269257883C94, H26988723B810, H272091228B2B, H27209152C623, H27209167BBE6, H272091785AC9, H269887193D22, H236302782ED8, H23987672CFA7, H24371481043C, H243714900C6D, H24371504C78D, H26309977FF02, H262962958810, H26375405C98F.

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.

device · product 6 of 7

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

Z-1504-2024
Recall number
Z-1504-2024
Initiated
March 19, 2024
Classification
Class I
Status
Ongoing
Recalling firm
Philips Respironics, Inc.
Quantity
76,713 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential for sudden loss of ventilation due to Battery Depleted or Loss of Power alarm while unit has sufficient power.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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.

device · product 7 of 7

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

Z-1505-2024
Recall number
Z-1505-2024
Initiated
March 19, 2024
Classification
Class I
Status
Ongoing
Recalling firm
Philips Respironics, Inc.
Quantity
9,999 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential for sudden loss of ventilation due to Battery Depleted or Loss of Power alarm while unit has sufficient power.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code information

Model No. DS2000X11B; UDI-DI: 606959052000; 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.