LifeVentEVO2, 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. 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.
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.