--- title: "Trilogy Evo O2 and LifeVentEVO2 Portable Electric Ventilator, Model Numbers D... — FDA record Z-1287-2023 | Is It on Recall" description: "The accuracy of delivered oxygen may deviate below the required tolerance of 5% from setpoint when providing high concentration oxygen therapy. Additionally, if" url: https://isitonrecall.com/recall/fda-device-z-1287-2023-trilogy-evo-o2-and-lifeventevo2-portable-electric-ventilator-model-numbers-ds2100x11b-in2100x15b-in2/ updated: 2026-10-01 site: "Is It on Recall" language: en --- [Recall archive](https://isitonrecall.com/archives/) / FDA device enforcement # Trilogy Evo O2 and LifeVentEVO2 Portable Electric Ventilator, Model Numbers DS2100X11B, IN2100X15B, IN2100X19, FX2100... — FDA record Z-1287-2023 Reported ongoing Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice. Source date Mar 1, 2023. Retrieved Oct 1, 2026. Last updated Oct 1, 2026. Archive changed Oct 1, 2026. USDA FSIS records are unavailable; [check FSIS directly](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/). ## What the record says - **Product**: Trilogy Evo O2 and LifeVentEVO2 Portable Electric Ventilator, Model Numbers DS2100X11B, IN2100X15B, IN2100X19, FX2100X15B, JP2100X16B, AU2100X15B, LA2100X15B, CA2100X12B, CN2100X17B, BR2100X18B, KR2100X15B, IA2100X15B, PP2100X10, FP2100X10, FR2100X14B, ND2100X15B, IT2100X21B, ES2100X15B, DE2100X13B, BL2100X15B, GB2100X15B, EU2100X15B, EU2100X19, EE2100X15B, TR2100X15B, UDS2100X11B, RDS2100X11B, and SP2100X26B - **Reason**: The accuracy of delivered oxygen may deviate below the required tolerance of 5% from setpoint when providing high concentration oxygen therapy. Additionally, if equipped, the internal FiO2 sensor may indicate a value higher than the device is actually delivering. This may lead to under delivery of oxygen. - **Classification**: Class I - **Recalling firm**: Philips Respironics, Inc. - **Quantity**: 62,826 total devices - **Agency-reported status**: Ongoing - **Source record identifier**: Z-1287-2023 [Open the official record](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1287-2023%22) [What the recall classes mean](https://isitonrecall.com/guides/recall-classes/). Classification is an agency assessment, not individual medical advice. ## Lot and product identifiers | Label field | Details supplied by the agency | | --- | --- | | Lot, code or applicability | UDI-DI: 606959051997, 606959054059, 606959055575, 606959061019, 606959055599, 606959055636, 606959062085, 606959055643, 606959055650, 606959055438, 606959054097, 606959054103, 606959055674, 606959055681, 606959055698. UDI-DI, Model Number: Serial numbers. 606959054103, DE2100X13B: H236054270DD5, H23630215A1ED, H23630353F967, H23708996882F, H24371560D579, H24762460B180, H24762461A009, H24762464F7A4, H255384963A07, H255386624A53, H25781923C0A4, H2578201604B2, H257820401F3C, H257820445918, H25782086D3AA, H25782201DC6D, H25787261E6EA, H2578730964AE, H25787344D82B, H2578742046DA, H257930337750, H257930373174, H25793039D80A, H25793041194A, H257930433A58, H257930444EE7, H257930477C7C, H25793048848B, H25793050111B, H257930510092, H257930532380, H2579305546B6, H25793056742D, H257930589D53, H257930612AFA, H257930621861, H2579306309E8, H257930656CDE, H257930665E45, H25793068B73B, H257930713322, H2579307201B9, H25793074648F, H257930757506, H25793085F6CE, H257930929BA9, H25958981A273, H25960485E33C, H259605245519, H259838090646, H260429505975, H26079674BBFF, H262014691128, H26201588C06D, H262017323E27, H262018544506, H26235313105F, H262468357A6E, H26256287C5EA, H26256295FF20, H262563002549, H2625630134C0, H262563289AB1, H262563404229, H26256353696A, H26259915AABF, H262602426DB1, H26260403CD81, H26260614155E, H26260629E4D3, H2626063060CA, H262607067548, H26260819DEA0, H262608513588, H2626088909B8, H262608908DA1, H262609000065, H2626092475F1, H26260948EB4D, H262609650318, H2626099580D0, H262610840824, H262610936543, H26261102F90E, H26261153963F, H262611955AA9, H26264213706C, H262642447A6B, H26264295DB9A, H262643435408, H26294959FB0C, H26295126948A, H262952013CE1, H262962198CBC, H2630989379EA, H263099095B74, H26309950B80D, H263099529B1F, H263455889BBA, H263456065360, H26345663501D, H263456878C29, H263759152F28, H26376023D9A5, H263761109B8A, H26376141F4BB, H26376148697A, H26381224257F, H26381297F34C, H26381348E11F, H26381427C13D, H26381523DDC5, H263905954BA4, H2639063559B0, H2639064737AA, H26390649DED4, H26390684AC91, H26390708F2E1, H263907423ADB, H263907566527, H26390791B838, H26436123B2B8, H26436132BAE9, H26436165B0EE, H264361807D53, H264442115D0C, H264442253140, H264442809B9D, H2646758207CF, H264676331D8A, H2646782643E4, H2646784706BD, H264678535941, H272300771C4D, H2723034821B6, H27230660A7F3, H27230853AF1B, H272311161F73, H27231120502D, H272315751A59, H27231688AD10, H272316974C3F, H27267776F0B4, H27267816EEA3, H27267830B825, H27267900C891, H272679439D6A, H27267951A7A0, H27267965CBEC, H27268002C564, H272680178B11, H272680348A3A, H27268044C732, H27268045D6BB, H27268099ACAF, 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, H800111191891, 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, H8001133554F5, 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. UDI-DI, Model Number: Serial numbers. 606959051997, DS2100X11B: H26581728CE54, H27737603821E, H277379248FD6, H277424271CB9, H277424352673, H277424447AF2, H277424474869, H27742449A117, H277424531795. UDI-DI, Model Number: Serial numbers. 606959055698, EE2100X15B,: H26201692998B, H262336530518, H262337246673, H2623372754E8, H262338307348, H26234008448B, H26234104D43B, H2623419512AA, H262352828C12, H80008934C421, H80008950D6D5, H80010279BF9E, H80010286C4A1, H800102929B5D, H8001031758EC, H800103367AD5, H8001035379A8, H800104038B15, H80010417D4E9, H80010432B0F4, H80010433A17D, H800104595AF7, H80010471E50F, H8001095129C0, H800110158821, H8001102879AC, H80011047D58B, H800110493CF5, H800110538A77, H80011055EF41, H80011056DDDA, H80011057CC53, H8001105834A4, H800110609284, H80011061830D, H80011064D4A0, H80011065C529, H80011066F7B2, H800110719AD5, H80011102BF9A, H80011104DAAC, H80011106F9BE, H800111090149, H80011113B7CB, H80011115D2FD, H80011116E066, H80011117F1EF, H80011463C37E, H8001147975FC, H800169471EB4, H8001695073D3, H8001695435F7, H80018231B16E, H80018234E6C3, H80018236C5D1, H80018241FC66, H80018944826D, H80018963C562, H80018970EE21. UDI-DI, Model Number: Serial numbers. 606959054097, ES2100X15B: H23605519941F, H239876768983, H239876806F7D, H24371562F66B, H25781757DB93, H257818119302, H25781910D857, H25781954F913, H25781966F069, H25781967E1E0, H25781995413A, H259590418B76, H2596048838D9, H2596106506F6, H259611456F9A, H259615770581, H26019364A002, H26044695A625, H260449152222, H2604519353AD, H2625630572E4, H262563130E0A, H262563232462, H262563333DBA, H26256346271F, H262563473696, H262563505BF1, H262563572F4E, H26256358D7B9, H26259933FC39, H262599846C2E, H26260015D20E, H262600659F06, H26260144E7E3, H26260342376D, H2626036642F9, H2626039939C6, H26260527E2C9, H26260564B732, H263098850504, H263760184D1E. UDI-DI, Model Number: Serial numbers. 606959055674, EU2100X15B: H23987675BB18, H243715497B08, H243715587359, H2476245817A0, H247624629292, H255250444AC7, H255250499122, H2552505327A0, H255250576184, H2552506568FE, H255384784969, H25538501C37C, H25538507A64A, H25538516AE1B, H25538517BF92, H25538554EA69, H25538572BCEF, H255386102449, H25538612075B, H2553863325... | The agency lot list is longer than this excerpt. [Read the complete list at the official source](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1287-2023%22). Match all identifying details in the current notice. A brand name alone is not enough. ## Distribution Worldwide distribution. US Nationwide including Puerto Rico, and countries of AE, AR, AT, AU, BD, BE, BG, BO, BR, CA, CH, CL, CN, CO, CZ, DE, DK, EC, EE, EG, ES, FI, FR, GB, GE, GT, HK, HR, HU, ID, IL, IE, IN, IT, JP, KW, LB, LT, MM, MQ, MX, MY, NG, NL, NO, NP, NZ, PE, PF, PH, PK, PL, PT, QA, RO, RS, RU, SA, SG, SI, SK, TH, TR, TW, UA, VN, and ZA. States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address. - [Alaska](https://isitonrecall.com/state/alaska/) - [Alabama](https://isitonrecall.com/state/alabama/) - [Arkansas](https://isitonrecall.com/state/arkansas/) - [Arizona](https://isitonrecall.com/state/arizona/) - [California](https://isitonrecall.com/state/california/) - [Colorado](https://isitonrecall.com/state/colorado/) - [Connecticut](https://isitonrecall.com/state/connecticut/) - [Delaware](https://isitonrecall.com/state/delaware/) - [Florida](https://isitonrecall.com/state/florida/) - [Georgia](https://isitonrecall.com/state/georgia/) - [Hawaii](https://isitonrecall.com/state/hawaii/) - [Iowa](https://isitonrecall.com/state/iowa/) - [Idaho](https://isitonrecall.com/state/idaho/) - [Illinois](https://isitonrecall.com/state/illinois/) - [Indiana](https://isitonrecall.com/state/indiana/) - [Kansas](https://isitonrecall.com/state/kansas/) - [Kentucky](https://isitonrecall.com/state/kentucky/) - [Louisiana](https://isitonrecall.com/state/louisiana/) - [Massachusetts](https://isitonrecall.com/state/massachusetts/) - [Maryland](https://isitonrecall.com/state/maryland/) - [Maine](https://isitonrecall.com/state/maine/) - [Michigan](https://isitonrecall.com/state/michigan/) - [Minnesota](https://isitonrecall.com/state/minnesota/) - [Missouri](https://isitonrecall.com/state/missouri/) - [Mississippi](https://isitonrecall.com/state/mississippi/) - [Montana](https://isitonrecall.com/state/montana/) - [North Carolina](https://isitonrecall.com/state/north-carolina/) - [North Dakota](https://isitonrecall.com/state/north-dakota/) - [Nebraska](https://isitonrecall.com/state/nebraska/) - [New Hampshire](https://isitonrecall.com/state/new-hampshire/) - [New Jersey](https://isitonrecall.com/state/new-jersey/) - [New Mexico](https://isitonrecall.com/state/new-mexico/) - [Nevada](https://isitonrecall.com/state/nevada/) - [New York](https://isitonrecall.com/state/new-york/) - [Ohio](https://isitonrecall.com/state/ohio/) - [Oklahoma](https://isitonrecall.com/state/oklahoma/) - [Oregon](https://isitonrecall.com/state/oregon/) - [Pennsylvania](https://isitonrecall.com/state/pennsylvania/) - [Rhode Island](https://isitonrecall.com/state/rhode-island/) - [South Carolina](https://isitonrecall.com/state/south-carolina/) - [South Dakota](https://isitonrecall.com/state/south-dakota/) - [Tennessee](https://isitonrecall.com/state/tennessee/) - [Texas](https://isitonrecall.com/state/texas/) - [Utah](https://isitonrecall.com/state/utah/) - [Virginia](https://isitonrecall.com/state/virginia/) - [Vermont](https://isitonrecall.com/state/vermont/) - [Washington](https://isitonrecall.com/state/washington/) - [Wisconsin](https://isitonrecall.com/state/wisconsin/) - [West Virginia](https://isitonrecall.com/state/west-virginia/) - [Wyoming](https://isitonrecall.com/state/wyoming/) ## Dates in the source - **Report date**: Apr 12, 2023 - **Recall initiation date**: Mar 1, 2023 - **Center classification date**: Apr 3, 2023 FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable. ## What to do next Read the official notice for the action that applies to your exact product. [Read the current instructions](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1287-2023%22) ## Related records [Medical devices records](https://isitonrecall.com/category/medical-devices/) [Philips Respironics, Inc. records](https://isitonrecall.com/brand/philips-respironics-inc/)