Aeris EVO, all software versions except 1.05.06.00. Ventilator for pediatric and adult patients. ...
FDA Device Recall #Z-1499-2024 — Class I — March 19, 2024
Recall Summary
| Recall Number | Z-1499-2024 |
| Classification | Class I — Serious risk |
| Date Initiated | March 19, 2024 |
| Status | Ongoing |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Philips Respironics, Inc. |
| Location | Murrysville, PA |
| Product Type | Devices |
| Quantity | 775 units |
Product Description
Aeris EVO, all software versions except 1.05.06.00. Ventilator for pediatric and adult patients. (sold outside US)
Reason for Recall
Potential for sudden loss of ventilation due to Battery Depleted or Loss of Power alarm while unit has sufficient power.
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.
Lot / 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.
Other Recalls from Philips Respironics, Inc.
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-1617-2026 | Class I | Philips Respironics Trilogy Evo Universal, Soft... | Mar 2, 2026 |
| Z-1615-2026 | Class I | Philips Respironics Trilogy Evo O2, Software Ve... | Mar 2, 2026 |
| Z-1616-2026 | Class I | Philips Respironics Trilogy EV300, Software Ver... | Mar 2, 2026 |
| Z-1614-2026 | Class I | Philips Respironics Trilogy Evo, Software Versi... | Mar 2, 2026 |
| Z-0481-2026 | Class II | SimplyGo Mini, Standard Battery Kit; Product c... | Oct 7, 2025 |
Frequently Asked Questions
Contact your physician immediately if you use an electrical device or implant affected by this recall. For external devices (monitors, pumps), stop using the device and contact the manufacturer for a replacement. For implanted devices (pacemakers, ICDs), your cardiologist will assess whether you need device replacement surgery — the decision depends on how dependent you are on the device and the actual failure rate observed in the field. Do not attempt to repair or modify a recalled electrical medical device yourself. Monitor for any new or unusual symptoms and report them to your doctor.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.