Recall archive / FDA device enforcement
Trilogy Evo O2 and LifeVent EVO2, Model Numbers DS2100X11B, IN2100X15B, IN2100X19, FX2100X15B, LA2100X15B, IA2100X15B... — FDA record Z-1650-2023
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 May 1, 2023. 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 and LifeVent EVO2, Model Numbers DS2100X11B, IN2100X15B, IN2100X19, FX2100X15B, LA2100X15B, IA2100X15B, FP2100X10, FR2100X14B, ND2100X15B, IT2100X21B, ES2100X15B, DE2100X13B, EU2100X15B, EU2100X19, EE2100X15B, and SP2100X26B
- Reason
- Environmental debris may accumulate on the internal machine flow sensor causing partial occlusion which may impact accurate delivery of pressure, volume, or flow. A malfunction caused by this issue can result in patient harm up to hypoxemia if not addressed by the care provider.
- Classification
- Class I
- Recalling firm
- Philips Respironics, Inc.
- Quantity
- 21,520 devices
- Agency-reported status
- Ongoing
- Source record identifier
- Z-1650-2023
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 | UDI-DI: 606959051997 606959054059 606959055575 606959061019 606959055599 606959055636 606959062085 606959055643 606959055650 606959055438 606959054097 606959054103 606959055674 606959055681 606959055698 606959057456; Serial Numbers: 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 H26581728CE54 H27737603821E H277379248FD6 H277424271CB9 H277424352673 H277424447AF2 H277424474869 H27742449A117 H277424531795 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 H23987675BB18 H243715497B08 H243715587359 H2476245817A0 H247624629292 H255250444AC7 H255250499122 H2552505327A0 H255250576184 H2552506568FE H255384784969 H25538501C37C H25538507A64A H25538516AE1B H25538517BF92 H25538554EA69 H25538572BCEF H255386102449 H25538612075B H255386332562 H2553865152A0 H256064131C99 H256064175ABD H2560642115E3 H2560642336F1 H25769588A2C4 H257696525282 H25769678CE68 H257697334D07 H2576974657A2 H25769794C4C8 H257698231E18 H257698662ED5 H25769919C1F6 H25769939F246 H25769960113F H25781710C84C H25781813B010 H2578183383A0 H257818579154 H2578187581F6 H25781887212C H2578205663D2 H25782109BF41 H257821415469 H2578217429AC H257872183623 H25787256B83D H25787321DB56 H25787375E3CA H25787398A23F H2579303266D9 H257930775614 H25793078AEE3 H25793079BF6A H25793081B0EA H2579308393F8 H25793087D5DC H257930893CA2 H25793091A932 H257930938A20 H257992561D3B H2579930728D6 H257993206FD9 H25799353104A H257993908B71 H25799434BC20 H2579946808F4 H2595874338DA H25958796DF0F H259588868C10 H25960289FF89 H25960603FD72 H259608845716 H2596180594E4 H259618609799 H259620165CA8 H259620670029 H259621273D95 H259621613FC3 H259622749ED2 H25962365CC5F H259624141CDB H2598401013BC H259864980B23 H25986675FF6E H259866793502 H26007501D0A0 H26007659CD34 H2600767534E8 H2600774676C7 H2600780569FB H260078354393 H260078653D2B H26007868E6CE H26019389E1F7 H2601939065EE H260193917467 H26019441481A H2601945517E6 H26019469F7E2 H26042573FDFD H260426674D65 H2604272553CB H260428226DB3 H260428423963 H26042887C76E H26043113D6F7 H260442711970 H260443303545 H260443894C2C H26044457992F H26044577F043 H26044607522F H26044681F9D9 H26201454E0A5 H262015181775 H2620160608B7 H26201669A490 H262016702089 H262017635116 H262018106442 H26234031F322 H26234121B026 H262341487937 H26235219E5D9 H262353968932 H26235400B719 H26235404F13D H26256297DC32 H2625630317D2 H26256308A901 H26256309B888 H26256317482E H2625632016F9 H2625632673CF H262563298B38 H262563322C33 H26256335588C H26256342613B H2625634370B2 H26259914BB36 H262611184F8C H26294798533E H26294990CF6D H262962895BA4 H263099386095 H263759828C8F H26375989325C H26376056C300 H26376177BBE5 H263761815D1B H2638122351C0 H26381308867F H263813189FA7 H263... |
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
US Nationwide. Global Distribution.
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
- Jun 14, 2023
- Recall initiation date
- May 1, 2023
- Center classification date
- Jun 2, 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.