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

What Should You Do?

1. Check if you have this product:
   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, 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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, 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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, 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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.
2. Do not eat it: Even if it looks and smells fine, do not consume this product.
3. Throw it away or return it: You can return the product to the store for a full refund.
4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
5. Report problems: Report any issues to the FDA's Safety Reporting Portal.