Recall archive / FDA device enforcement
Trilogy Evo O2, all software versions except 1.05.06.00. Ventilator for pediatric and adult patients. — FDA record Z-1503-2024
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 19, 2024. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- Trilogy Evo O2, all software versions except 1.05.06.00. Ventilator for pediatric and adult patients.
- Reason
- Potential for sudden loss of ventilation due to Battery Depleted or Loss of Power alarm while unit has sufficient power.
- Classification
- Class I
- Recalling firm
- Philips Respironics, Inc.
- Quantity
- 789 units
- Agency-reported status
- Ongoing
- Source record identifier
- Z-1503-2024
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | 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, H24371504C7... |
The agency lot list is longer than this excerpt. Read the complete list at the official source.
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
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.
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
- Alaska
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- Delaware
- Florida
- Georgia
- Hawaii
- Iowa
- Idaho
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Maine
- Michigan
- Minnesota
- Missouri
- Mississippi
- Montana
- North Carolina
- North Dakota
- Nebraska
- New Hampshire
- New Jersey
- New Mexico
- Nevada
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- Rhode Island
- South Carolina
- South Dakota
- Tennessee
- Texas
- Utah
- Virginia
- Vermont
- Washington
- Wisconsin
- West Virginia
- Wyoming
Dates in the source
- Report date
- Apr 24, 2024
- Recall initiation date
- Mar 19, 2024
- Center classification date
- Apr 17, 2024
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.