Recall archive / FDA device enforcement
Trilogy Evo; Model No./Model Description -- AU2110X15B Trilogy Evo, Australia BL2110X15B Trilogy Evo, Benelux BR2110X... — FDA record Z-2944-2024
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 Jul 16, 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; Model No./Model Description -- AU2110X15B Trilogy Evo, Australia BL2110X15B Trilogy Evo, Benelux BR2110X18B Trilogy Evo, Brazil CA2110X12B Trilogy Evo, Canada DE2100X13B Trilogy Evo O2, Germany DE2110X13B Trilogy Evo, Germany DS2100X11B Trilogy Evo, O2, USA DS2110X11B Trilogy Evo, USA DS2110X11B Trilogy Evo, USA EE2100X15B Trilogy Evo O2, Eastern Europe EE2110X15B Trilogy Evo, Eastern Europe ES2100X15B Trilogy Evo O2, Iberia ES2110X15B Trilogy Evo, Iberia EU2100X15B Trilogy Evo, O2, EU EU2100X19 Trilogy Evo, O2, EU (Non-BT) EU2110X15B Trilogy Evo, EU EU2110X19 Trilogy Evo, EU (Non-BT) FR2100X14B Trilogy Evo O2, France FR2110X14B Trilogy Evo, France FX2100X15B Trilogy Evo, O2, INT GB2110X15B Trilogy Evo, Great Britain IA2100X15B Trilogy Evo O2, India IA2110X15B Trilogy Evo, India IN2100X15B Trilogy Evo, O2, International IN2100X19 Trilogy Evo, O2, International (Non-BT) IN2110X15B Trilogy Evo, International IT2100X21B Trilogy Evo O2, Italy IT2110X21B Trilogy Evo, Italy JP2100X16B Trilogy Evo, O2, Japan JP2110X16B Trilogy Evo, Japan KR2110X15B Trilogy Evo, Korea LA2100X15B Trilogy Evo, O2, Latin America LA2110X15B Trilogy Evo, Latin America LD2110X23B Garbin Evo, Linde ND2100X15B Trilogy Evo O2, Nordics ND2110X15B Trilogy Evo, Nordics RDS2110X11B Trilogy Evo, USA-Rental SP2100X26B LifeVentEVO2 TR2110X15B Trilogy Evo, Turkey UDS2110X11B Trilogy Evo, USA-RECERT VT2110X24B Aeris EVO
- Reason
- Firm has released a mandatory software update Version 1.05.10.00 and a User Manual addendum for affected ventilators. These updates resolve safety issues identified in earlier recalls.
- Classification
- Class I
- Recalling firm
- Philips Respironics, Inc.
- Quantity
- 90,910 US; 56,273 ROW
- Agency-reported status
- Ongoing
- Source record identifier
- Z-2944-2024
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 Description/ UDI-DI-- Trilogy Evo, Australia 606959051980; Trilogy Evo, Benelux 606959055520; Trilogy Evo, Brazil 606959055476; Trilogy Evo, Canada 606959052307; Trilogy Evo O2, Germany 606959054103; Trilogy Evo, Germany 606959054110; Trilogy Evo, O2, USA 606959051997; Trilogy Evo, USA 606959051942; Trilogy Evo, USA 606959051942; Trilogy Evo O2, Eastern Europe 606959055698; Trilogy Evo, Eastern Europe 606959055544; Trilogy Evo O2, Iberia 606959054097; Trilogy Evo, Iberia 606959054080; Trilogy Evo, O2, EU 606959055674; Trilogy Evo, O2, EU (Non-BT) 606959055681; Trilogy Evo, EU 606959054981; Trilogy Evo, EU (Non-BT) 606959055537; Trilogy Evo O2, France 606959055643; Trilogy Evo, France 606959055506; Trilogy Evo, O2, INT 606959061019; Trilogy Evo, Great Britain 606959054127; Trilogy Evo O2, India 606959055636; Trilogy Evo, India 606959055490; Trilogy Evo, O2, International 606959054059; Trilogy Evo, O2, International (Non-BT) 606959055575; Trilogy Evo, International 606959051959; Trilogy Evo O2, Italy 606959055438; Trilogy Evo, Italy 606959055421; Trilogy Evo, O2, Japan 606959055582; Trilogy Evo, Japan 606959051973; Trilogy Evo, Korea 606959055483; Trilogy Evo, O2, Latin America 606959055599; Trilogy Evo, Latin America 606959055452; Garbin Evo, Linde 606959057432; Trilogy Evo O2, Nordics 606959055650; Trilogy Evo, Nordics 606959055513; Trilogy Evo, USA-Rental 606959060517; LifeVentEVO2 606959057456; Trilogy Evo, Turkey 606959055551; Trilogy Evo, USA-RECERT 606959060500; Aeris EVO 606959062962; US Serial Nos. H25772938289E H31256551DA06 H2645481034BB H264549117FEE H293726775CF8 H293726839914 H29373939849A H3219367937EE H32194038C0FF H312413120541 H3125248270D5 H31252485046A H312586847CF5 H31260269A675 H3126027133E5 H3126145857F6 H31261473DA95 H312614853C6B H31261492510C H31261503CD41 H31261510E602 H31261553B3F9 H31261557F5DD H31261565FCA7 H3126168943BF H31261692E4B4 H31261693F53D H312616948182 H31261696A290 H31261697B319 H312617015BEB H312617051DCF H312617062F54 H312617073EDD H31261708C62A H31261709D7A3 H3126171053BA H3126171270A8 H312617136121 H35712170BF53 H35713165ED9D H35718858401B H357297078DE4 H35730100DDA5 H357301279AAA H35730132D4DF H35730164CF51 H3573020211D3 H357312415893 H35731259CD03 H357313262220 H357313498E07 H357313500A1E H35731352290C H35731452A509 H35731467D8CC H357315768A41 H35731743423C H357317443683 H357317461591 H357317535BE4 H357317626005 H35731768CF5F H3573177279DD H35731778D687 H35731779C70E H35731787ADB8 H357318005D00 H357318173067 H3573183520C5 H35731854659C H35731874562C H35731896EF2E H357319132C9F H36031701B2F1 H36031707D7C7 H360317093EB9 H360317281C80 H36031743F683 H36031744823C H3603174593B5 H36031751CC49 H360317549BE4 H360317824EAA H36088293C1C9 H36088294B576 H360900410987 H36101867D037 H36101875EAFD H361018792091 H361018803E98 H361018821D8A H361018830C03 H361018874A27 H3610189753FF H36101899BA81 H36101900AA84 H361019028996 H36101903981F H36101904ECA0 H36101905FD29 H3610190826CC H361019093745 H36101911A2D5 H3610191381C7 H361099004F5C H361099015ED5 H361099037DC7 H36109937118B H36109940283C H3610994139B5 H361099464D0A H361099556649 H361099676F33 H361099744470 H3610997555F9 H361099766762 H3610997776EB H361099788E1C H361099799F95 H36109980819C H361099819015 H36109983B307 H36109984C7B8 H36109985D631 H36109986E4AA H36109987F523 H361099909844 H3610999189CD H36109992BB56 H36109993AADF H36109995CFE9 H36127266EFD6 H361273759E49 H363518889CD2 H36358463E4D1 H363596437E62 H363599125B94 H3636016234F1 H363602768469 H363603874CF4 H36360439CD27 H363604410C67 H363604631CC5 H36360494EBB2 H363605289FAA H36360616B3D8 H363606439ACD H36360666FED0 H36360704D3CE H36360726C36C H3636077854AA H36360802FC3F H36360867FF42 H363608977C8A H36360903B76A H36360915CB84 H36360931BE10 H36360947962E H363609497F50 H363619827498 H364081649356 H364081862A54 H364088166152 H36031627BEAB H36031666C842 H360317192761 H36031740C418 H36031761E621 H360317779ACF H3603177973B1 H36034756D6A1 H360350809351 H3603510116C4 H3603511892DD H360351313CAC H36035191C1DC H360352068D1F H36035220DB99 H36035236A777 H360352509691 H360353092F34 H360353208145 H36035327F5FA H36035339055C H3603534859DD H360353668313 H360353834EAE H36035408B2B8 H36035412043A H360354288108 H360354398959 H36035469F7E1 H360354869506 H360369802A82 H36075517245B H360755521496 H3607606664AA H3607631280E2 H36076459D554 H3607651347B2 H3607658390AA H36080843E713 H36080944C970 H3608101705F6 H3608147265EA H36081492FFFA H36081546537A H360815655251 H36081643EBB3 H360816697759 H36081671E2C9 H360817249100 H360817581664 H36090185BCDF H36092201E229 H36092203C13B H36098204692A H360983774C65 H36098384FD36 H360983939051 H36098395F567 H36098397D675 H360983982E82 H360983993F0B H36101855D94D H36101856EBD6 H36101857FA5F H3610185802A8 H361018591321 H36101862879A H36101864E2AC H361018729E42 H3610189570ED H36101906CFB2 H36101907DE3B H36101910B35C H36101912904E H361064320BA0 H3610644246A8 H36106444239E H36106722FD1C H36106864B58D H36106920CE15 H3610707567A5 H36107081A249 H361071536BFF H361072059F15 H361072976B1F H361074948F5D H361075051310 H361075114CEC H361075136FFE H361075141B41 H36107520770D H361075234596 H3610752703B2 H361075317F5C H361075512B8C H361075777D0A H36107587FEC2 H3610762905A8 H3610768711A6 H36107689F8D8 H36107722E1A7 H361077248491 H361077259518 H36107726A783 H36107727B60A H361077409665 H36107759127C H36107774FA29 H361077931486 H361078092603 H36107811B393 H361078139081 H36107832B2B8 H36107834D78E H36107903D385 H361079518E2F H36107967C171 H361079683986 H36107970AC16 H3610802788F6 H36108033D70A H36108034A3B5 H36108076E7C7 H361080780EB9 H361081282ADD H361081863ED3 H36108196270B H361082237B6A H361082350784 H36108278BB01 H361098542D1C H361098553C95 H361098560E0E H36109858E770 H36109859F6F9 H361098604150 H3610986150D9 H361098626242 H3610986373CB H361098640774 H3610986516FD H361098662466 H3610986735EF H36109868CD18 H36109869DC91 H361098705888 H361098727B9A H361098741EAC H361098763DBE H361098772C37 H36109878D4C0 H36109880DB40 H36109881CAC9 H36109882F852 H36109883E9DB H361098858CED H36109982A28E H361099891C5D H36109994DE60 H36109996FD72 H36109997ECFB H3611757002F1 H36127313AFAF H36127343D117 H361273804A2C H36366049A8D4 H36366083AE2E H3636689260BD H363670342282 H363682261F09 H3636836401A7 H3636837509F6 H36368440F836 H3636846847CE H363684695647 H36368476B768 H36368485063B H36368502E698 H3636855389A9 H363685844D6E H36368591031B H363686013B67 H363704336939 H36370496C3E4 H36370503198D H36370508A75E H36370518BE86 H36370534475A H363705440A52 H363705462940 H36370549D1B7 H36370559C86F H36370569E207 H3637057531B3 H363705969938 H36459055C884 H3646101332C6 H36463185E342 H36463252C8E1 H3646326487BF H36463303FD0C H364633185A07 H36505612B8C9 H36508839AE3E H365089172E2C H27608081120B H276080910BD3 H276102568DE8 H324086107B09 H324086152CA4 H302451170A6D H32338979F9C2 H32338566BD4E H32338888315F H32338899390E H32815772E728 H328236497F19 H32824650AC21 H32824664C06D H328246718E18 H32824676FAA7 H36443698BBF2 H3644389204B3 H36444528E71F H36446112383A H36446223ECBF H364462249800 H364462408AF4 H364462581F64 H364462590EED H36446275F731 H36446277D423 H36446299A74D H36446327F047 H364463309D20 H364463686FD0 H36446371EBC9 H3644643100AC H36446459D834 H364464606F9D H364465263717 H36446528DE69 H3644656562EC H364465665077 H36446595E124 H36446597C236 H364467593750 H364467845CCD H3644742543EB H364474377921 H364474426384 H364632962765 H36463368170F H365061996112 H36507921D38B H365088553082 H36508940242B H365089556A5E H36509020F05E H36509137C7E5 H364146648323 H364147708603 H36414772A511 H36414802A2DE H36414805D661 H364151751BCC H36415205B9A0 H364152068B3B H364152187B9D H364152249B99 H36415254D691 H3641528466E9 H364153139F92 H36415314EB2D H364154332027 H36415650F3D4 H36415651E25D H3641567597C9 H364157933233 H36415794468C H36415828228F H324642768522 H3246445337E6 H34829473CBF0 H348420075830 H34842082C15D H292745158BEF H292746013B77 H292746031865 H292746670A91 H29274690FDE6 H2927472626A4 H29790074F0D8 H297903303EF8 H29790431A374 H325983203D93 H3366315961A3 H28938506A878 H28949206081A H291829623AE0 H29183006A8B1 H29297064AAA6 H29297072D648 H29297073C7C1 H2929707781E5 H29297087022D H29297113C9CD H29297120D13E H29297122F22C H292971419467 H292971509C36 H262947320114 H284899949759 H2849600023C6 H29075517BC10 H290775782941 H31581394C556 H318096285808 H31813566EE98 H26264918E719 H26265015BC59 H262749454900 H262749993314 H26640848B7B5 H283582564853 H283582688B45 H28938453DBB1 H289385048B6A H29166073BDFB H291660844A8C H291660899169 H29167305661A H291674595ECB H29167547F4B1 H291702120DC4 H291702233625 H2917409753FD H29177012EF5D H291770823845 H31054027FAA5 H31054034D1E6 H31054042F9D8 H31054051D29B H31054057B7AD H31054061F8F3 H31054063DBE1 H310540686532 H31054072D3B0 H31054077841D H31871105E95C H3187110832B9 H318711208D41 H31871126E877 H318711318510 H31871188FC79 H31871203630E H318743510A2F H318743554C0B H318743746E32 H3198002829B9 H31980030BC29 H31980110D545 H319822100357 H3198223030E7 H319822443BCB H31982293FF0C H3198230151DA H31982309DD92 H319823136B10 H31982318D5C3 H31982321626A H31982325244E H31982328FFAB H319823342C1F H319823446117 H31982348AB7B H319823565BDD H319823574A54 H31982397E3F4 H31982407B8E9 H31982411C407 H31982420FFE6 H31982424B9C2 H3198242873AE H31982434A01A H319824368308 H31982441BABF H3198244936F7 H31982462BB94 H3514258353CF H35142893B568 H304266974E07 H304276591262 H30427915F5A9 H304279449A98 H304279924FD6 H30428140A887 H30428173B074 H30432220C4D9 H3611785953FF H3612019383F6 H3612132699F0 H36121822F672 H29111863051C H29126780ADBD H29268218407F H297711058B86 H30660892676D H25932048ED3A H290128700FB9 H35579468E0A5 H2907776994A8 H29078458F2D4 H301754234E2D H301755054277 H301786025223 H301789244E62 H301789299587 H302364446AE2 H303732718692 H30390700A7DB H31818312F378 H318234597B17 H31823520F102 H3182359899E2 H318236311637 H318236563658 H31823681F29F H318238436836 H318238472E12 H3182394774CE H31823963015A H318239702A19 H318239746C3D H31823978A651 H31824011A47F H31824015E25B H31824017C149 H318240218E17 H3182402813D6 H318240970F89 H3237138263D0 H32393852A2C0 H325900123E55 H325939787C0C H325940117E22 H325940756CD6 H325941404BCF H32595836E354 H3259594091B6 H32595975EC73 H325960464D53 H32596824FC53 H325972739995 H3259729745A1 H325982325D85 H32598238F2DF H3259824475BB H32598249AE5E H325982520955 H3259939849C8 H32599554FCDD H3259959102D0 H339149651D11 H33926351269D H339263565222 H339263689134 H339263755309 H3392637888EC H354685305B5D H2637541087FA H26375444BF66 H2637581133D0 H263758504539 H263758617ED8 H263758624C43 H26375884B365 H26375894AABD H26390842701C H263908463638 H26390853784D H263908617137 H26390869FD7F H2639087168EF H263908725A74 H2639088876E6 H263909024DA0 H2639091166E3 H263909422AC0 H263909603A62 H263909713233 H26390987D4CD H26390999246B H263910079AA8 H26391032E76D H26391045DEDA H263910782F57 H26391100B4CB H26425564EC8F H264256177C78 H264256347D53 H264256461349 H26425669D80E H264256984A4F H26425739FC6A H264824029C3C H273682352A20 H273683203E89 H273683636B72 H273685268D66 H275075216842 H275075360525 H2750755651F5 H27507602860D H27507616D9F1 H2835827458F1 H283583154774 H283583274E0E H28358338AF21 H283584658679 H284880497C61 H28489981D92C H2849012110B9 H284901515DB1 H28653366EC75 H28659525B3F9 H286596074C3F H2866613031D8 H286661312051 H2866613212CA H286661330343 H2866613477FC H286661356675 H28670494F3EF H286724447AE1 H2867244659F3 H28672448B08D H286724513494 H286805818DBA H28778099AA98 H28781802960E H292723644A2D H29272401C555 H2929691313B4 H29517985FBD0 H306188335E90 H3061883718B4 H306188446727 H30619166F720 H30623298B390 H306233038087 H30623305E5B1 H30623343E7E7 H30623372DC06 H3062337962D5 H306294285D4F H306324174481 H3063244408A2 H3063245723E1 H3063247064EE H30632485B08B H3063250162B3 H30632594E206 H306326018DD7 H30632861C91C H312010078940 H31216562EFE5 H31216577A190 H312524597E7E H317517353EEC H317517777A9E H3175179909F0 H317518212BD7 H317518247C7A H317518375739 H31751849F34F H317518543172 H317518672981 H31751873767D H317552230953 H3175524538B5 H317552471BA7 H317552859115 H3... |
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
Worldwide distribution: US (nationwide) and OUS (foreign) countries of: AU, BD, BE, BG, BO, BR, BS, CH, CL, NL, CN, CO, CZ, DE, DK, FR, SE, GB, GF, GR, GT, HK, HR, HU, IE, IL, IN, IT, JP, KE, KW, LB, LT, MA, ME, MA, MT, MQ, MX, NO, NP, OM, PA, PE, PF, PK, PL, PT, PY, QA, RE, RO, RS, RU, SA, SE, SI, SK, SG, TH, TN, TR, TW, UA, YT, ZA and 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
- Sep 11, 2024
- Recall initiation date
- Jul 16, 2024
- Center classification date
- Sep 4, 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.