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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 92048

4 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
May 01, 2023
Product types
Device
Classifications
Class I
Statuses
Ongoing
Recalling firm wording
Philips Respironics, Inc.

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

4 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 4

Trilogy Evo, Garbin Evo, and Aeris EVO, Model Numbers DS2110X11B, IN2110X15B, JP2110X16B, AU2110X15B, LA2110X15B, CA2110X12B, BR2110X18B, KR2110X15B, IA2110X15B, FP2110X10, FR2110X14B, ND2110X15B, IT2110X21B, ES2110X15B, DE2110X13B, BL2110X15B, GB2110X15B, EU2110X15B, EE2110X15B, LD2110X23B, and VT2110X24B

Z-1649-2023
Recall number
Z-1649-2023
Initiated
May 01, 2023
Classification
Class I
Status
Ongoing
Recalling firm
Philips Respironics, Inc.
Quantity
57,395 devices

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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.

Code information

UDI-DI: 606959051942 606959051959 606959051973 606959051980 606959055452 606959052307 606959055476 606959055483 606959055490 606959062092 606959055506 606959055513 606959055421 606959054080 606959054110 606959055520 606959054127 606959054981 606959055544 606959057432 606959062962; Serial Numbers: H316330493348 H31633062BE2B H31633067E986 H3163306900F8 H316330719568 H31633072A7F3 H31633073B67A H31633074C2C5 H31633077F05E H31633084410D H316330899AE8 H316330910F78 H316330923DE3 H3163309892B9 H31633102B027 H3168304974A4 H31683060DAD5 H31683061CB5C H31683081514C H3168308263D7 H3168308406E1 H31683087347A H31683088CC8D H31683090591D H316830927A0F H316830936B86 H316830941F39 H31683100D4D9 H31683101C550 H31683102F7CB H31696034875A H31696053A735 H31696059086F H316960638D5D H31696067CB79 H316960739485 H31696077D2A1 H3169608206C4 H3169608640E0 H316960921F1C H3169609748B1 H31696101A043 H31696105E667 H31696118245A H31696123B0E1 H317352405480 H317354480E11 H31735507CB5A H31735568677D H317359517577 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H26375520F74E H26375551ABCF H2637557089F6 H263756013A13 H263756103242 H263756276C95 H2637581133D0 H263758504539 H263758617ED8 H263758624C43 H26375884B365 H26375894AABD H2639082224CC H263908301E06 H263908376AB9 H26390842701C H263908463638 H26390853784D H263908617137 H26390869FD7F H2639087168EF H263908725A74 H2639088876E6 H263909024DA0 H2639091166E3 H263909422AC0 H263909603A62 H263909713233 H26390987D4CD H26390999246B H263910079AA8 H26391032E76D H26391045DEDA H26391061AB4E H263910782F57 H26391100B4CB H2640274719B5 H26402862376F H2640293567B4 H26402959F908 H26408226B9FF H26408317D8C2 H264083953510 H26408468E138 H26408698D748 H264087832A9F H26408932CFA5 H264112347112 H264113225720 H26411444EAC3 H26411499815E H26411561D402 H264116034CA4 H264117366BBD H264117625321 H26411780EA23 H264118422A56 H26411868B6BC H264119551DED H26411981EBB1 H26412051E21A H26412073F2B8 H2641211953EE H26412139605E H264122277F9C H264122869365 H2641230350D4 H264123477190 H264123656132 H26412564A662 H26412592409C H2641263614AC H264126732461 H264127320854 H264127859843 H264129045711 H2641294344CE H26412986BAC3 H26413155E259 H26413198901C H264142721D13 H26414394B8E9 H26414432ACAA H264144817A99 H2641449617FE H264207868E62 H264208035DC8 H264208576554 H264208630918 H264209146A73 H26420918A01F H26421000B52A H26421011BD7B H26421052E880 H264210861EDC H264211079B49 H26421131D417 H26421171B377 H264211921BFC H264252142D82 H264252215047 H264252500CC6 H264252730DED H26425286D988 H26425290A566 H26425297D1D9 H264253031A39 H264253462AF4 H264253643A56 H26425376009C H26425399627B H26425424D133 H26425427E3A8 H26425441D24E H26425461E1FE H26425462D365 H26425474AF8B H264254970700 H26425502DD69 H264255259A66 H26425542BA09 H26425564EC8F H264255931BF8 H264256177C78 H264256347D53 H264256461349 H26425669D80E H264256984A4F H26425714143F H264257225B61 H26425739FC6A H26425750357B H264257601F13 H2642576982D2 H2642577663FD H26425792BFC9 H2644512184BB H26445156BD0C H26445172C898 H264542072AA6 H264542235F32 H26454228E1E1 H264542644CED H264542723003 H2645428090D9 H264542919888 H264543110C94 H264543313F24 H264543507A7D H264543737B56 H26454578135C H26454591148D H264546003D78 H264546405A18 H264546515249 H26454653715B H26454695BDCD H264547060292 H264547241230 H264547373973 H264547523A0E H264547621066 H26454768BF3C H26454784EF40 H264548013CEA H2645481034BB H264548437898 H2645485415FF H264548724379 H2645487352F0 H26454874264F H264549117FEE H26454918E22F H264549341BF3 H26454985EED2 H2645500783A5 H26455054CF86 H264550738889 H264551391A6F H26455160F916 H264602157F4C H264602301B51 H264602354CFC H2646791147EF H264679676FD1 H264680510E68 H26469220FBEA H26469256D3D4 H26469379424F H264694199A9A H26470043DA3E H26470062F807 H26470072E1DF H26470177ECAE H26470294AB41 H264703576AA6 H264703839CFA H26470442A8D6 H264704518395 H26470542F20A H264706421D6E H2647079492FC H264708216B3E H26470897EAA0 H26470920206B H2647096733B4 H264711185C32 H26471166F844 H2647116900B3 H2647120205D4 H26471411F84E H26471562DD01 H264715797A0A H264717246AEF H2647175427E7 H2647205955CA H26472088F43B H2647214916CE H264721638A24 H264724159BA7 H2647273010DE H2647279861E6 H2647285448ED H26472994BB91 H26474256531F H264742990248 H26474431A5A9 H26474454A6D4 H2647448416AC H264745976733 H264746311011 H26482268B16F H26482309AEEA H264824029C3C H26492690D6CA H264927072FB1 H264927253F13 H26492758A9FE H26492783A755 H264928054664 H264929610E4C H26492996F93B H26493003F92B H26493012F17A H26493021E989 H26493041BD59 H264930609F60 H264930888938 H2649308998B1 H2649309890E0 H26493198CA3C H264952332D61 H264952734A01 H26495283C9C9 H26495288771A H26495318FADE H264953205CFE H264953250B53 H264953746462 H26495396DD60 H264954097E8A H264954178E2C H26495446E11D H264954518C7A H26495506DCA1 H265027453E8C H26502969D74B H2650424986C7 H26504261393F H26504295FCD3 H265043147946 H265043473565 H265043753C1F H26504385BFD7 H2650441381FC H265044484197 H26504464B84B H2650448356E4 H26504521D25A H26504542B411 H265047371B0C H265047547D47 H265048011E95 H2650483134FD H265048552609 H26504869C60D H26504873708F H265049206670 H2650492531DD H265049412329 H265049789480 H26504992A1CA H26505031EE84 H26505072BB7F H26505074DE49 H26505102ACAB H2650518373E2 H2650519058A1 H265072063C9D H26507229F7DA H265072564225 H26507285C0C6 H265073145C8B H265073313896 H265128918953 H26512900151E H265129133E5D H265129199107 H265129303F76 H265129330DED H265129374BC9 H265129506BA6 H2651295248B4 H265129542D82 H26512987AF61 H26512993F09D H26515792A62E H26515793B7A7 H265158032A78 H2651581110B2 H265158202B53 H26515829B692 H265158470B3C H265158750246 H26515890CFFB H265159114A6E H265159141DC3 H26516066CA0A H26516137FFE7 H265161594249 H265161779887 H265172520F45 H26517260063F H265172688A77 H2651727893AF H26517296E0C1 H265173132370 H26517328B7CB H265173471BEC H2651735430AF H26517379D8FA H265173958886 H26517426D2B0 H26517441F2DF H265174569FB8 H26517473FBA5 H2651749142A7 H26517503EC71 H265175148116 H26517526886C H26517531E50B H26517554E676 H26517571826B H26517584560E H265176288E76 H26517649CB2F H26517664237A H26517681EEC7 H26517734071E H26517739DCFB H2651775015EA H265177554247 H26517774607E H265178289E6D H265178514EA4 H2651787609AB H26527065F9E6 H265271308A2F H26527141D6AE H26527153EC64 H2652716691A1 H265271786107 H265272004F23 H265272015EAA H265272037DB8 H265285883357 H26528590A6C7 H26528591B74E H2652859285D5 H26528594E0E3 H26528596C3F1 H26528597D278 H265285993B06 H265286018F32 H26528602BDA9 H26528603AC20 H26528605C916 H26528609037A H265286108763 H2652861196EA H26528612A471 H265286180B2B H265286191AA2 H26528620AD0B H26528621BC82 H265286228E19 H26528625FAA6 H265286282143 H2652862930CA H26528631A55A H265286338648 H26528636D1E5 H26528637C06C H26528641E852 H265286487593 H26528649641A H26528650E003 H265286568535 H265286648C4F H265286827369 H26528702E775 H26

Distribution pattern

US Nationwide. Global Distribution.

device · product 2 of 4

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

Z-1650-2023
Recall number
Z-1650-2023
Initiated
May 01, 2023
Classification
Class I
Status
Ongoing
Recalling firm
Philips Respironics, Inc.
Quantity
21,520 devices

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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.

Code information

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 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H800012314349 H8000123271D2 H80001233605B H8000123414E4 H80001235056D H8000123637F6 H80001237267F H80001238DE88 H80001239CF01 H800012401FC8 H800012410E41 H800012423CDA H800012432D53 H8000124459EC H800012454865 H800012467AFE H800012476B77 H800012489380 H800012498209 H800012500610 H800012511799 H800012522502 H80001253348B H800012544034 H8000125551BD H800012566326 H8000125772AF H800012588A58 H800012599BD1 H800012602C78 H800012613DF1 H800012620F6A H800012631EE3 H800012646A5C H800012657BD5 H80001266494E H8000126758C7 H80001268A030 H80001269B1B9 H8000127035A0 H800012712429 H8000127216B2 H80001273073B H800012747384 H80001275620D H800012765096 H80001277411F H80001278B9E8 H80001279A861 H80001280B668 H80001281A7E1 H80001282957A H8000128384F3 H80001284F04C H80001285E1C5 H80001286D35E H80001287C2D7 H800012883A20 H800012892BA9 H80001290AFB0 H80001291BE39 H800012928CA2 H800012939D2B H80001294E994 H80001295F81D H80001296CA86 H80001297DB0F H8000129823F8 H800012993271 H800013002274 H8000130133FD H800013020166 H8000130310EF H800013046450 H8000130575D9 H800013064742 H8000130756CB H80001308AE3C H80001309BFB5 H800013103BAC H800013112A25 H8000131218BE H800013130937 H800013147D88 H800013156C01 H800013165E9A H800013174F13 H80001318B7E4 H80001319A66D H8000132011C4 H80001321004D H8000132232D6 H80001323235F H8000132457E0 H800013254669 H8000132674F2 H80001327657B H800013289D8C H800013298C05 H80001330081C H800013311995 H800013322B0E H800013333A87 H800013344E38 H800013355FB1 H800013366D2A H800013377CA3 H800013388454 H8000133995DD H800013404514 H80001341549D H800013426606 H80001343778F H800013440330 H8000134512B9 H800013462022 H8000134731AB H80001348C95C H80001349D8D5 H800013505CCC H800013514D45 H800013527FDE H800013536E57 H800013541AE8 H800013550B61 H8000135639FA H80001358D084 H80001369EB65 H800013706F7C H800013717EF5 H800013724C6E H800013735DE7 H80001385BB19 H80001390F56C H80001391E4E5 H80001392D67E H80001446AC27 H80001447BDAE H80001452F3DB H80001453E252 H8000145496ED H800014558764 H80001457A476 H80001461EB28 H800014925A7B H800014934BF2 H800014943F4D H800014952EC4 H80001499E4A8 H80001500F4AD H800015248139 H800015358968 H80001542B0DF H80001544D5E9 H80001545C460 H80001546F6FB H80001547E772 H800015481F85 H800015490E0C H800015508A15 H800015519B9C H80001552A907 H80001553B88E H80001554CC31 H80001555DDB8 H80001557FEAA H80001558065D H8000155917D4 H80001560A07D H80001561B1F4 H80001562836F H80001565F7D0 H80001566C54B H80001567D4C2 H800015682C35 H800015693DBC H80001570B9A5 H80001571A82C H800015729AB7 H800015738B3E H80001574FF81 H80001575EE08 H80001576DC93 H80001577CD1A H8000157835ED H800015792464 H800015803A6D H800015812BE4 H80001582197F H8000158308F6 H800015847C49 H800015856DC0 H800015865F5B H800015874ED2 H80001588B625 H80001589A7AC H8000159023B5 H80001591323C H8000159200A7 H80001593112E H800015946591 H800015957418 H800015964683 H80001597570A H80001598AFFD H80001599BE74 H800016001BC9 H800016010A40 H8000160238DB H800016032952 H800016045DED H800016054C64 H800016067EFF H800016076F76 H800016089781 H800016098608 H800016100211 H800016111398 H800016122103 H80001613308A H800016144435 H8000161555BC H800016166727 H8000161776AE H800016188E59 H800016199FD0 H800016202879 H8000162139F0 H800016220B6B H800016231AE2 H800016246E5D H800016257FD4 H800016264D4F H800016275CC6 H80001628A431 H80001629B5B8 H8000163031A1 H800016312028 H8000163212B3 H80001633033A H800016347785 H80001635660C H800016365497 H80001637451E H80001638BDE9 H80001639AC60 H800016407CA9 H800016416D20 H800016425FBB H800016434E32 H800016506571 H8000165174F8 H800016524663 H8000165357EA H800016542355 H8000165532DC H800016560047 H8000165711CE H80001658E939 H80001659F8B0 H800016604F19 H800016615E90 H800016626C0B H800016637D82 H80001664093D H8000166518B4 H800016662A2F H800016673BA6 H80001668C351 H80001669D2D8 H8000167056C1 H800016714748 H8000167275D3 H80001673645A H8000167410E5 H80001675016C H8000167633F7 H80001677227E H80001678DA89 H80001679CB00 H80001682F61B H80001683E792 H80001684932D H800016885941 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H800017755BB0 H80001776692B H8000177778A2 H800017788055 H8000177991DC H800017808FD5 H800017819E5C H80001782ACC7 H80001783BD4E H80001784C9F1 H80001785D878 H80001786EAE3 H80001787FB6A H80001788039D H800017891214 H80001790960D H80001794D029 H80001795C1A0 H80001796F33B H80001797E2B2 H800017981A45 H800017990BCC H800018000BD2 H800018011A5B H8000180228C0 H800018033949 H800018044DF6 H800018055C7F H800018066EE4 H800018077F6D H80001808879A H800018099613 H800018123118 H80001814542E H8000181545A7 H80001816773C H800018189E42 H800018198FCB H800018274CDD H80001829A5A3 H8000183021BA H800018313033 H8000183202A8 H800018331321 H800018375505 H80001838ADF2 H80001839BC7B H800018406CB2 H800018417D3B H800018424FA0 H800018435E29 H800018442A96 H800018453B1F H800018460984 H80001847180D H80001848E0FA H80001849F17

Distribution pattern

US Nationwide. Global Distribution.

device · product 3 of 4

Trilogy Evo O2 EV300, Model Numbers DS2200X11B, IN2200X15B, FX2200X15B, CA2200X12B, FR2200X14B, ND2200X15B, ES2200X15B, BL2200X15B, GB2200X15B, EU2200X15B, EE2200X15B, and TR2200X15B

Z-1651-2023
Recall number
Z-1651-2023
Initiated
May 01, 2023
Classification
Class I
Status
Ongoing
Recalling firm
Philips Respironics, Inc.
Quantity
18,855 devices

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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.

Code information

UDI-DI: 606959052017 606959056497 606959061033 606959052321 606959058613 606959058620 606959058644 606959058668 606959058675 606959058682 606959058705 606959058798; Serial Numbers: H800088856BDC H800088865947 H80008889A1B0 H800088913420 H8000889206BB H800089218A54 H295004989AF7 H295005081733 H29500526CDFD H29500537C5AC H29500543CE80 H29500550E5C3 H29500557917C H29500562ECB9 H2950058276A9 H29500589C87A H295005940A47 H2950064102F6 H29500644555B H2950064767C0 H295006500AA7 H295006566F91 H295006577E18 H295006599766 H29500695F4AA H295007020DD1 H29500710371B H29500716522D H295007210CFA H2950072769CC H295007333630 H29500748C5EB H29500782C311 H29500785B7AE H29500791E852 H29500808E84C H295008107DDC H2950081618EA H295008304E6C H295008362B5A H295008400364 H2950084554C9 H2950086030D4 H2950086213C6 H29500867446B H295008731B97 H29500878A544 H29500881BB4D H29500883985F H29500885FD69 H295109734A0F H295684188A77 H29568454277B H295684894CE6 H2956852613BD H295702706AAA H295702771E15 H29570309E0BF H2957035666F0 H295722010F5D H29571147C7A2 H295733206B03 H29638720E91A H2957187552C6 H29570525CFBA H295714846524 H29571655716D H29572553DEF2 H295726025EA7 H2957263057DD H295721975217 H29572909AAB3 H29572948DC5A H295731629AC9 H29573293E7EC H29572435B5C8 H295733352576 H295749410A01 H295753542BB5 H29575430B544 H295754469D7A H29575462E8EE H29575472F136 H29575718E5D8 H295759024341 H295759576A54 H29576146810A H295772160C6D H29577227378C H29577239C72A H295772522D29 H29577269B992 H295772774934 H2957735631D1 H2957737176DE H29577382C78D H29638222F3B5 H296384752F6B H296385152167 H29638556749C H296385674F7D H29638579BFDB H29638661C52F H296386649282 H296386694967 H29638673FFE5 H296386804EB6 H29638692747C H29638700DAAA H29638711D2FB H295727388149 H29638731E14B H296387429ED8 H29638754E236 H296387619FF3 H296387790A63 H29638786715C H29638860C4BD H29638870DD65 H29638877A9DA H2963889375EE H29638924BF25 H29638946C8E7 H2963896903A0 H2963898770CE H296389901DA9 H296412616FF1 H296412634CE3 H2964127067A0 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H293421856DEB H293422001BE2 H2934322217FB H293432230672 H2934322651DF H29343229A928 H293432302D31 H293432320E23 H293432331FAA H29343237598E H2934324352A2 H29343244261D H293432453794 H29343246050F H293432471486 H29343248EC71 H29343249FDF8 H2934325079E1 H293432516868 H293432525AF3 H29343262709B H293432636112 H2934326415AD H293432650424 H2934327378CA H293432773EEE H29343280C999 H29343281D810 H29343282EA8B H29343283FB02 H293432949665 H2934329587EC H29343296B577 H29343297A4FE H293432985C09 H293432994D80 H293433027E97 H293433050A28 H2934330638B3 H29343307293A H29343308D1CD H29343309C044 H2934331155D4 H29343312674F H293433235CAE H293433242811 H293433260B03 H293433271A8A H29343329F3F4 H2934333077ED H293433316664 H293459134E26 H29345927226A H2934598288B7 H29345985FC08 H29345996D74B H29346002FFA4 H29346011D4E7 H2934601592C3 H2934601958AF H29346023DD9D H29346040BBD6 H29346056C738 H29346072B2AC H293460944D8A H29346106E35C H29346116FA84 H293461339E99 H29346146843C H29346158749A H29346209F4CF H29346218FC9E H29346239DEA7 H2934625017B6 H293462630F45 H29346281B647 H29346287D371 H29346297CAA9 H293463157DA7 H293463244646 H2934633895F2 H29346345031F H29346358C122 H2934636530AF H293463734C41 H2934722732BA H293472363AEB H2934725996CC H293472712934 H29347294E489 H293473473CB6 H29347436EC32 H29347532F0CA H29347542BDC2 H29347553B593 H29347565FACD H29347576D18E H293475865246 H29347599B369 H2934760673E2 H2934773177E9 H2934774319F3 H29347930767B H293480262472 H293480498855 H293480721CEE H29348084FA10 H29348118BDB8 H293481300240 H293481505690 H293481625FEA H29348178E968 H29349809354C H293498183D1D H293498209B3D H29349822B82F H29349824DD19 H29349827EF82 H293498281775 H29349834C4C1 H293498380EAD H29349840CFED H2934984489C9 H293498459840 H29349846AADB H29349847BB52 H29349850D635 H29349853E4AE H29349856B303 H293498594BF4 H29349860FC5D H29349862DF4F H2934986788E2 H29349870E585 H29349873D71E H2934987680B3 H29349880664D H29349882455F H2934988531E0 H293498907F95 H293498934D0E H29349898F3DD H29349901E3D8 H29349903C0CA H29349905A5FC H2934990786EE H293499096F90 H29349911FA00 H29349913D912 H293499284DA9 H29349930D839 H29349933EAA2 H293499358F94 H29349936BD0F H29349937AC86 H293499385471 H293499409531 H29349943A7AA H29349945C29C H293499481979 H29349953BE72 H29349954CACD H29349957F856 H293499591128 H29349963941A H29349966C3B7 H293499682AC9 H293499729C4B H29349974F97D H29349977CBE6 H293499803C91 H293499821F83 H293499830E0A H29349987482E H29349989A150 H29349992065B H2934999317D2 H2934999572E4 H2934999751F6 H29350004DA4C H29350007E8D7 H29350015D21D H29350017F10F H293500239D43 H29350024E9FC H29350025F875 H29350026CAEE H29350212131A H2935022328FB H293502634F9B H29350284A134 H29350295A965 H2935030524A1 H293503153D79 H29350326258A H29350339C4A5 H293503511C3D H2935035881FC H293503730C9F H29350386D8FA H29350395F3B9 H29350405A8A4 H293521591CBB H29352160AB12 H29352161BA9B H293521628800 H293521639989 H29352164ED36 H29352165FCBF H29352166CE24 H29352167DFAD H29352168275A H2935216936D3 H29352170B2CA H29352171A343 H2935217291D8 H293521738051 H29352174F4EE H29352175E567 H29352176D7FC H29352177C675 H293521783E82 H293521792F0B H293521803102 H29352181208B H293521821210 H293521830399 H293521847726 H2935218566AF H293521865434 H2935218745BD H29352188BD4A H29352189ACC3 H2935219028DA H293521913953 H293521920BC8 H29361692BFCC H29361699011F H293617089D52 H293617177C7D H2936172201B8 H293844179CF6 H293844358C54 H29384444D0D5 H293844490B30 H29384457FB96 H293844693880 H29384475EB34 H293844812ED8 H293914805A42 H29391498CFD2 H29391499DE5B H29391502ED4C H29391503FCC5 H29391504887A H2939150599F3 H29391506AB68 H29391507BAE1 H293915084216 H29391509539F H2939160313A1 H2939164374C1 H2939164732E5 H29391655082F H293916652247 H293916724F20 H29391677188D H29391683DD61 H29391690F622 H2939170

Distribution pattern

US Nationwide. Global Distribution.

device · product 4 of 4

Trilogy Evo Universal Ventilator, Model Number DS2000X11B

Z-1652-2023
Recall number
Z-1652-2023
Initiated
May 01, 2023
Classification
Class I
Status
Ongoing
Recalling firm
Philips Respironics, Inc.
Quantity
22,237 devices

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The Trilogy Evo Universal ventilator provides continuous or intermittent positive pressure ventilation for the care of individuals who require mechanical ventilation. Trilogy Evo Universal is intended for pediatric through adult patients weighing at least 2.5 kg. The ventilator can measure, display, record, and alarm SpO2, FiO2, CO2, and pulse rate data when integrated with the appropriate accessories. The ventilator is suitable for use in institutional and hospital settings and non-emergency transport settings; for example, wheelchair. It may be used for both invasive and non-invasive ventilation.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

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Reason for recall

The Trilogy Evo Universal ventilator provides continuous or intermittent positive pressure ventilation for the care of individuals who require mechanical ventilation. Trilogy Evo Universal is intended for pediatric through adult patients weighing at least 2.5 kg. The ventilator can measure, display, record, and alarm SpO2, FiO2, CO2, and pulse rate data when integrated with the appropriate accessories. The ventilator is suitable for use in institutional and hospital settings and non-emergency transport settings; for example, wheelchair. It may be used for both invasive and non-invasive ventilation.

Code information

UDI-DI: 606959052000; Serial Numbers: H27736231F4BE H277362379188 H27736246CD09 H277372867812 H27737288916C H2773729661CA H27737302AA2A H27737306EC0E H2773730914F9 H27737331B2D9 H27737344A87C H277373468B6E H277373596A41 H277373815671 H2773738401DC H2773740998FC H277374132E7E H277374212704 H277374525897 H277374740E11 H277374848DD9 H27737492F137 H27737496B713 H277375206C51 H277375242A75 H2773757677DF H277375789EA1 H27737583A3BA H27737593BA62 H27737607C43A H27737614EF79 H27737624C511 H27737635CD40 H27737646B2D3 H27737656AB0B H27737664A271 H2773767871C5 H277376870AFA H27737700EA59 H27737702C94B H277378459053 H27737846A2C8 H27737847B341 H27737853ECBD H277378549802 H27737869698F H277378779929 H277378925494 H277378970339 H2773792845BA H27737966CBA4 H27737971A6C3 H277379821790 H2773801950BC H27738021F69C H277380378A72 H27738043815E H27738052890F H27738057DEA2 H277380680C3D H277380801A65 H277380867F53 H27738088962D H277380933126 H277381019FF0 H2773814974D8 H27738152D3D3 H27738154B6E5 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H29349882455F H2934988531E0 H293498907F95 H293498934D0E H29349898F3DD H29349901E3D8 H29349903C0CA H29349905A5FC H2934990786EE H293499096F90 H29349911FA00 H29349913D912 H293499284DA9 H29349930D839 H29349933EAA2 H293499358F94 H29349936BD0F H29349937AC86 H293499385471 H293499409531 H29349943A7AA H29349945C29C H293499481979 H29349953BE72 H29349954CACD H29349957F856 H293499591128 H29349963941A H29349966C3B7 H293499682AC9 H293499729C4B H29349974F97D H29349977CBE6 H293499803C91 H293499821F83 H293499830E0A H29349987482E H29349989A150 H29349992065B H2934999317D2 H2934999572E4 H2934999751F6 H29350004DA4C H29350007E8D7 H29350015D21D H29350017F10F H293500239D43 H29350024E9FC H29350025F875 H29350026CAEE H29350212131A H2935022328FB H293502634F9B H29350284A134 H29350295A965 H2935030524A1 H293503153D79 H29350326258A H29350339C4A5 H293503511C3D H2935035881FC H293503730C9F H29350386D8FA H29350395F3B9 H29350405A8A4 H293521591CBB H29352160AB12 H29352161BA9B H293521628800 H293521639989 H29352164ED36 H29352165FCBF H29352166CE24 H29352167DFAD H29352168275A H2935216936D3 H29352170B2CA H29352171A343 H2935217291D8 H293521738051 H29352174F4EE H29352175E567 H29352176D7FC H29352177C675 H293521783E82 H293521792F0B H293521803102 H29352181208B H293521821210 H293521830399 H293521847726 H2935218566AF H293521865434 H2935218745BD H29352188BD4A H29352189ACC3 H2935219028DA H293521913953 H293521920BC8 H29361692BFCC H29361699011F H293617089D52 H293617177C7D H2936172201B8 H293844179CF6 H293844358C54 H29384444D0D5 H293844490B30 H29384457FB96 H293844693880 H29384475EB34 H293844812ED8 H293914805A42 H29391498CFD2 H29391499DE5B H29391502ED4C H29391503FCC5 H29391504887A H2939150599F3 H29391506AB68 H29391507BAE1 H293915084216 H29391509539F H2939160313A1 H2939164374C1 H2939164732E5 H29391655082F H293916652247 H293916724F20 H29391677188D H29391683DD61 H29391690F622 H293917007BE6 H293917052C4B H2939171173B7 H29391718EE76 H2939173634B8 H29391797D841 H293918003121 H2939180120A8 H2939180303BA H29391808BD69 H29391809ACE0 H2939181028F9 H293918113970 H293918120BEB H293918131A62 H293918146EDD H29391883CD7A H29391982862F H29391996D9D3 H29392002F13C H293920085E66 H29392013F96D H29392021F017 H293920378CF9 H29392045E2E3 H29392057D829 H29392064C0DA H29392072BC34 H2939207902E7 H2939360109C5 H2939363123AD H293936443908 H29393658EABC H293936651B31 H2939367721FB H293936894B4D H293937004290 H293937114AC1 H293937342EDC H29393823097C H29393832012D H293939474154 H293939546A17 H293939798242 H29394010806C H293940228916 H293940478A6B H293940915F25 H2939410594C5 H29394124B6FC H293941386548 H293941482840 H2939416097B8 H29394176EB56 H293941945254 H29396283E921 H29396296A754 H2939631722C1 H293963335755 H293963457F6B H293963755503 H293963891CA7 H2939639814F6 H29396407B71C H293964185633 H2939642784AC H2939644287D1 H293964538F80 H29396466F245 H2939648779DC H29396499897A H2939651080A7 H293965239854 H29396531A29E H29396543CC84 H29396555B06A H293965749253 H29396589CA7E H293966025509 H293966160AF5 H29396629D86A H29396718B957 H293967232DEC H293967267A41 H29396728933F H293967388AE7 H293967451C0A H293967978F60 H29396809FBC1 H29397063DA32 H293970769447 H293970870606 H29397098E729 H293971086AED H29397121C49C H29397130CCCD H29397139510C H29397153AA86 H293971683E3D H2939717827E5 H293971930326 H2939876581F8 H29398802EB50 H29398813E301 H293988379695 H29398854F0DE H293988609C92 H2939904701E4 H29399411790B H293994142EA6 H293994171C3D H293994314ABB H293994454197 H2939946640BC H293994765964 H29399489225B H293994993B83 H2939951123D7 H293995254F9B H29399734F272 H29399753D21D H29399771C2BF H293997940F02 H293998159A8C H29399821F6C0 H29399833CC0A H29399844F5BD H29399855FDEC H29399862A33B H2939987815B9 H293998867F0F H29401228B016 H29401240688E H29401248E4C6 H2940126369A5 H29401273707D H29401280C12E H29401290D8F6 H29401292FBE4 H29401297AC49 H294013041316 H294013151B47 H294015229349 H294015283C13 H29401535FE2E H29401554BB77 H29401558711B H29401563E5A0 H29401575994E H29401586281D H29401591457A H29401598D8BB H294016024F9D H294016071830 H294018016D1D H294018025F86 H294018043AB0 H294018052B39 H29401810654C H294018336467 H294018410A7D H29401843296F H29401856671A H294018664D72 H2940190137C1 H2940190752F7 H2940236135A6 H2940236316B4 H294023664119 H29402368A867 H294023703DF7 H294023747BD3 H29402379A036 H294023838CA4 H294023883277 H2940239284F5 H294023993A26 H29402403CE61 H29402418696A H29402421DEC3 H29402424896E H294024284302 H29402432F580 H29402435813F H294024394B53 H294024418A13 H29402444DDBE H29402452A150 H29402454C466 H294024821128 H29402486570C H294024913A6B H294024957C4F H29402500A626 H294025028534 H29402507D299 H294025961408 H294028217B60 H294028430CA2 H29402858ABA9 H294028789819 H294028881BD1 H294028980209 H294029110BD4 H2940292121BC H294029375D52 H2940294601D3 H294029552A90 H294029859AE

Distribution pattern

US Nationwide. Global Distribution.