CLASS II ONGOING Device recall · Reported 12 Jul 2023 · FDA Enforcement Report

Trilogy Evo, Evo Clinical Korean (1137823) recalled

Philips Respironics is recalling Trilogy Evo, Evo Clinical Korean (1137823) and Evo Caregiver Korean (1137853). The recall was initiated on 25 May 2023 and the FDA has classified it as Class II.

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Lot, batch or date codesMaterial No. KR2110X15B, GTIN: 00606959055483; Serial No. H30665832F44A, H3066588656C6, H306658946C0C, H30665905F041, H306659391045, H30665956BC62, H30665965A491, H306659871D93, H30665993426F, H306660257A22, H306660321745, H30666039A996, H306660506087, H30666058ECCF, H306660637874, H30666068C6A7, H3066608496DB, H30666098456F, H3066612703EC, H306661402383, H30666141320A, H306661420091, H306661431118, H3066614646B5, H30666147573C, H306661601033, H3066617009EB, H306661755E46, H30670227AC56, H30670253A77A, H306702638D12, H306702692248, H30670276C367, H3067028463BD, H30670298B009, H30670303831E, H30670315FFF0, H30670327F68A, H30670336FEDB, H306703485AAD, H306703548919, H30670361F4DC, H306703697894, H306703834DDE, H30670392458F, H306704030F1B, H3067041135D1, H306704244814, H306704376357, H306704441CC4, H30670454051C, H306704606950, H3067047615BE, H30670484B564, H306704887F08, H3067051438A0, H30670519E345, H306705236677, H306705250341, H306705326E26, H3067054332A7, H306705455791, H30670546650A, H306705567CD2, H306705630117, H30670568BFC4, H30670584EFB8, H30670590B044, H30670597C4FB, H3067061091E0, H30670615C64D, H30670624FDAC, H30670625EC25, H306706292649, H30670644A97C, H306706587AC8, H30670667A857, H306706784978, H306706837463, H30670688CAB0, H30670695088D, H30670703E07F, H306707094F25, H30670720E154, H30670725B6F9, H30670734BEA8, H30670741A40D, H30670765D199, H306707718E65, H3067077813A4, H306707854B89, H3067079226EE, H306707977143, H30670802BB31, H306708119072, H30670861DD7A, H30670872F639, H30670873E7B0, H306708758286, H30670876B01D, H3067088410C7, H30670889CB22, H30670903F064, H30670912F835, H3067091946E6, H30670940A59F, H30670949385E, H30670955EBEA, H306709681A67, H30670975D85A, H306709800C3F, H306709833EA4, H3067099236F5, H30671000425A, H3067100515F7, H306710141DA6, H30671028FDA2, H30671048A972, H3067105659D4, H306710623598, H3067106673BC, H306710700F52, H306710777BED, H30671083BE01, H30671095C2EF, H306711045EA2, H3067111110D7, 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H3229874673C5, H322987721F89, H32298785E8FE, H32298818AEC4, H3229882008E4, H322988441A10, H322988606F84, H322989152FFD, H32298918F418, H3229894006E8, H322989567A06, H3229897649B6, H322989882300, H32299002C23F, H32299027A622, H322990294F5C, H32299071BDAC, H32299089B22C, H3229909127BC, H32299171E770, H32299173C462, H32299185229C, H32299198E0A1, H322992050338, H32299209C954, H322992140B69, H32299218C105, H322992253088, H322992260213, H322992352950, H322992361BCB, H322992370A42, H3229924210E7, H32299243016E, H32299249AE34, H322992557D80, H322992622357, H3229926557E8, H322992723A8F, H322992732B06, H32299415CC39, H32299446801A, H322994479193, H322994694B5D, H322994826F9E, H322995889A18, H322996056059, H32299608BBBC, H322996323E8E, H3229966351BF, H32299668EF6C, H32299715235D, H3229973375DB, H322997501390, H32299769A439, H322997702020, H3229979927F1, H322998121D25, H32299818B27F, H3229983881CF, H3229984625B9, H32299859C496, H322998771E58, H322999034FA8, H322999273A3C, H322999476EEC, 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H32518995A7CC, H325190129D16, H32519014F820, H32519023A6F7, H325190319C3D, H32519033BF2F, H32519041D135, H325190558EC9, H32519061E285, H32519074ACF0, H325190797715, H32519088E554, H32519097047B, H32519111F551, H325191295371, H32519136B25E, H325191519231, H32519152A0AA, H32519170B008, H32519174F62C, H32519198A650, H3251920320FF, H32524221A61E, H32524224F1B3, H32524242C055, H32524254BCBB, H325242685CBF, H32524270C92F, H32524283787C, H325242862FD1, H3252430498DF, H325243058956, H32524320ED4B, H32524322CE59, H325243438B00, H32524346DCAD, H32524366EF1D, H3252437093F3, H325243889C73, H3252440271EC, H325244072641, H32524424276A, H3252444650A8, H325244513DCF, H325244520F54, H325244776B49, H32524484DA1A, H3252448901FF, H325245044E06, H325245176545, H32524528B7DA, H325245417ECB, H325245552137, H32524570452A, H32524578C962, H32524592FC28, H32524594991E, H325245958897, H32524602C454, H32524603D5DD, H32524605B0EB, H325246086B0E, H32524610FE9E, H32524661A21F, H32524663810D, H32524674EC6A, H32524704FBBE, H325247193983, H32524743E861, H32524760E94A, H32524763DBD1, H325247668C7C, H325247796D53, H3252478707E5, H32524803C5C6, H32524814A8A1, H32524832FE27, H3252484181B4, H32524845C790, H32524871ABDC, H325248729947, H325248821A8F, H32524889A45C, H32524905FA2C, H325249209E31, H325249459D4C, H32524956B60F, H32524962DA43, H32524974A6AD, H3252498534EC, H325249943CBD, H325250013CAD, H325250388B04, H325250634B6F, H32525076051A, H325251034563, H325251327E82, H32525138D1D8, H3252515118C9, H325251522A52, H325251657485, H32525168AF60, H32525180B938, H32525186DC0E, H32525195F74D, H325251993D21, H32525200989C, H32526207C9EE, H32526215F324, H325262208EE1, H325262219F68, H325263359A48, H3252634080ED, H32526352BA27, H3252635904F4, H32526364F579, H32526377DE3A, H32526388A505, H325264017A01, H3252642149B1, H32526429C5F9, H325264477857, H3252646568F5, H32526478AAC8, H32526497C82F, H32526508BD1C, H3252652221F6, H3252654147BD, H325265504FEC, H325265716DD5, H32526584B9B0, H32526594A068, H3252660943F1, H32526620ED80, H32526622CE92, H32526632D74A, H32526636916E, H32526654E6AC, H325266582CC0, H32526673A1A3, H32526704C2C8, H32526724F178, H32526736CBB2, H325267578EEB, H32526773FB7F, H32532425763D, H325324347E6C, H325324571827, H32532458E0D0, H32532463746B, H32532465115D, H325324750885, H325324858B4D, H32532487A85F, H325324894121, H32532491D4B1, H32532493F7A3, H32532496A00E, H327515253AE2, H327515307497, H3275153432B3, H32751538F8DF, H327515412816, H327515456E32, H327515502047, H327515546663, H32751558AC0F, H32751562293D, H32751571027E, H32751573216C, H3275157455D3, H327515776748, H32751582B32D, H32751587E480, H3275159089E7, H32751606D4AD, H32751617DCFC, H32751622A139, H32751625D586, H327516318A7A, H32751633A968, H3275163817BB, H32751642F5E9, H327516458156, H32751650CF23, H327516548907, H32751657BB9C, H32751662C659, H32751664A36F, H32751669788A, H32751674BAB7, H3275167870DB, H327516816ED2, H32751684397F, H327516924591, H327517097686, H32751711E316, H32751714B4BB, H327517196F5E, H32751726BDC1, H32751732E23D, H327517359682, H327517384D67, H32751742AF35, H327517629C85, H327517638D0C, H32751764F9B3, H32751774E06B, H32751775F1E2, H32751781340E, H3275178463A3, H327517921F4D, H327517930EC4, H32751799A19E, H32751805F62D, H32751810B858, H32751814FE7C, H32751823A0AB, H327518290FF1, H327518308BE8, H32751835DC45, H32751845914D, H32751846A3D6, H32751847B25F, H327518558895, H3275185942F9, H32751860F550, H3275186781EF, H32751870EC88, H32751871FD01, H327518779837, H3275187860C0, H327518842964, H32751909669D, H32751910E284, H32751911F30D, H32751931C0BD, H32751932F226, H327519385D7C, H327519394CF5, H32751944DA18, H3275195085E4, H32751952A6F6, H32751955D249, H32751957F15B, H327519639D17, H32751966CABA, H3275197384CF, H32751976D362, H32751980359C, H327519812415, H32751982168E, H32751988B9D4, H327519902C44, H327519920F56, H3275201369CC, H327520141D73, H32752020713F, H327520270580, H3275204025EF, H327520413466, H327520457242, H3276227284E1, H32762305E78A, H327623092DE6, H327623139B64, H32762322A085, H32762327F728, H32762339078E, H327623449163, H3276234580EA, H327623494A86, H32762353FC04, H3276236681C1, H32762375AA82, H327623825DF5, H32762385294A, H32762394211B, H327624003C22, H327743519FC8, H32774366C11F, H327743682861, H327743812FB0, H327744993625, H327745130D63, H32774525423D, H327745355BE5, H327745527B8A, H327745706B28, H327746048F60, H32774606AC72, H32774624BCD0, H327746397EED, H327746538567, H32774674C268, H327746910FD5, H32774706F6AE, H327747180608, H32774731A879, H32774744B2DC, H327747695A89, H327747827E4A, H3277479621B6, H32774811D10E, H32774829772E, H32774844F81B, H32774857D358, H32774865DA22, H327748790996, H327748944863, H327749080FCB, H32774924F617, H3277494681D5, H32774963E5C8, H32774977BA34, H3277499631AD, H327750066610, H327750132865, H32775019873F, H327750274429, H32775082EEF4, H3277508841AE, H327751050E57, H327751206A4A, H3277513616A4, H3277515136CB, H32775166681C, H3277517671C4, H32775186F20C, H32775202958C, H32775217DBF9, H327752318D7F, H32775246B4C8, H3277526796F1, H327752825B4C, H32775299FC47, H3277531879D2, H327753359187, H3277534916E3, H327753692553, H3277539309C1, H3277540714F8, H32775425045A, H3277544116AE, H327754523DED, H32775481BF0E, H32775519BE82, H3277553010F3, H327755450A56, H327755671AF4, H32775582D749, H327755997042, H32775647C620, H32775664C70B, H3277567814BF, H32775693307C, H3277570912E2, H32775721AD1A, H32945548F5DD, H3294557270EF, H32945579CE3C, H32945580D035, H32945586B503, H32945596ACDB, H32945610E849, H32945620C221, H329456284E69, H329456508F29, H32945657FB96, H3294570399D6, H32945710B295, H32945711A31C, H32945725CF50, H32945756B0C3, H32945788E9C5, H32945799E194, H32945801F003, H329458079535, H32945824941E, H329458258597, H32945830CBE2, H3294584086EA, H32945860B55A, H32945861A4D3, H32945876C9B4, H32945877D83D, H329458921580, H329458930409, H32945901AADF, H32945908371E, H32945916C7B8, H32945936F408, H329459449A12, H32945960EF86, H32945971E7D7, H3294597782E1, H32945998E006, H32946007763A, H329470727024, H329471733B71, H32947210B25E, H32947241DD6F, H329472696297, H32947320C2EA, H329473519E6B, H3294739137CB, H3294745445C3, H3294747567FA, H32947650B65F, H329476932D64, H32947810C124, H32947904C404, H32947963E46B, H32948017C1A0, H32948166C7FD, H32948215570A, H3294827503DA, H32948345736E, H32948422DF04, H329484538385, H32948477F611, H32948520A6CA, H32948695FAAB, H3295565195E4, H32955726F68F, H32955743F5F2, H3295575852F9, H329557835C52, H32955798FB59, H32955799EAD0, H32955805BD63, H329558079E71, H3295581787A9, H329558285536, H32955845DA03, H32955857E0C9, H32955861AF97, H329558638C85, H3295588750B1, H32955888A846, H329558921EC4, H32955907C4AD, H32955916CCFC, H32955927F71D, H329559280FEA, H329559485B3A, H329559494AB3, H32955959536B, H3295596681F4, H32955970FD1A, H32955971EC93, H3295597789A5, H32955989E313, H3295599713B5, H329560022AD3, H32956012330B, H329560189C51, H329560256DDC, H329560375716, H329560460B97, H329560507779, H329560627E03, H32956069C0D0, H3295607044C9, H32956078C881, H32956093EC42, H32956100531D, H32956109CEDC, H3295612243BF, H3295614125F4, H32956148B835, H32956149A9BC, H329561655060, H32956187E962, H329561881195, H329582144DC7, H329582166ED5, H32958246106D, H32958249E89A, H329582615762, H329582714EBA, H32958280DCFB, H329583026BF5, H329583335014, H3295833607B9, H32958352154D, H329583667901, H3295837660D9, H329583891BE6, H32958396FAC9, H32958417A985, H329584185172, H329584269264, H32958444E5A6, H32958445F42F, H329584529948, H32958456DF6C, H32958464D616, H32958467E48D, H329584719863, H32958488866A, H3295848997E3, H329584976745, H32958513B57D, H32958515D04B, H329585228E9C, H32958541E8D7, H32958542DA4C, H329644475DC5, H32964448A532, H32964449B4BB, H3296445030A2, H32964451212B, H3296445213B0, H329644530239, H329644547686, H32964455670F, H329644565594, H32964457441D, H32964458BCEA, H32964459AD63, H329644601ACA, H329644610B43, H3296446239D8, H329644632851, H329644645CEE, H329644654D67, H329644667FFC, H329644676E75, H329644689682, H32964469870B, H329644700312, H32964471129B, H329644722000, H329644733189, H329644744536, H3296447554BF, H329644766624, H3296447777AD, H329644788F5A, H329644799ED3, H3296448080DA, H329644819153, H32964482A3C8, H32964483B241, H32964484C6FE, H32964485D777, H32964486E5EC, H32964487F465, H329644880C92, H329644891D1B, H329644909902, H32964491888B, H32964492BA10, H32964493AB99, H32964494DF26, H32964495CEAF, H32964496FC34, H32964497EDBD, H32964498154A, H3296449904C3, H3296450014C6, H32964501054F, H3296450237D4, H32964503265D, H3296450452E2, H32964505436B, H3296450671F0, H329645076079, H32964508988E, H329645098907, H329645100D1E, H329645111C97, H329645122E0C, H329645133F85, H329645144B3A, H32969977035D, H32970007206C, H3297002713DC, H329700325DA9, H32970034389F, H329700447597, H329700502A6B, H329700564F5D, H3297007019DB, H329700710852, H329700789593, H32970079841A, H32970086FF25, H32970093B150, H329701011F86, H329701066B39, H329701077AB0, H3297010993CE, H3297011017D7, H330052762D78.

Quantity recalled1,581 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2106-2023
FDA event ID: 92515
Recalling firm: Philips Respironics, Murrysville, PA
Classification: Class II
Status: Ongoing
Recall initiated: 25 May 2023
FDA classified: 6 Jul 2023
Reported: 12 Jul 2023
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

25 May 2023	Recall initiated by company
6 Jul 2023	Classified by FDA	+42 days
12 Jul 2023	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

There are errors present in the Korean Instructions For Use where the word "invasive," was incorrectly translated to "noninvasive".

Product as listed by the FDA

Trilogy Evo, Evo Clinical Korean (1137823) and Evo Caregiver Korean (1137853) Instructions for Use

Where it was distributed

Foreign Distribution: Korea.

Questions about this recall

Why was it recalled?

There are errors present in the Korean Instructions For Use where the word "invasive," was incorrectly translated to "noninvasive".

Which lots are affected?

Material No. KR2110X15B, GTIN: 00606959055483; Serial No. H30665832F44A, H3066588656C6, H306658946C0C, H30665905F041, H306659391045, H30665956BC62, H30665965A491, H306659871D93, H30665993426F, H306660257A22, H306660321745, H30666039A996, H306660506087, H30666058ECCF, H306660637874, H30666068C6A7, H3066608496DB, H30666098456F, H3066612703EC, H306661402383, H30666141320A, H306661420091, H306661431118, H3066614646B5, H30666147573C, H306661601033, H3066617009EB, H306661755E46, H30670227AC56, H30670253A77A, H306702638D12, H306702692248, H30670276C367, H3067028463BD, H30670298B009, H30670303831E, H30670315FFF0, H30670327F68A, H30670336FEDB, H306703485AAD, H306703548919, H30670361F4DC, H306703697894, H306703834DDE, H30670392458F, H306704030F1B, H3067041135D1, H306704244814, H306704376357, H306704441CC4, H30670454051C, H306704606950, H3067047615BE, H30670484B564, H306704887F08, H3067051438A0, H30670519E345, H306705236677, H306705250341, H306705326E26, H3067054332A7, H306705455791, H30670546650A, H306705567CD2, H306705630117, H30670568BFC4, H30670584EFB8, H30670590B044, H30670597C4FB, H3067061091E0, H30670615C64D, H30670624FDAC, H30670625EC25, H306706292649, H30670644A97C, H306706587AC8, H30670667A857, H306706784978, H306706837463, H30670688CAB0, H30670695088D, H30670703E07F, H306707094F25, H30670720E154, H30670725B6F9, H30670734BEA8, H30670741A40D, H30670765D199, H306707718E65, H3067077813A4, H306707854B89, H3067079226EE, H306707977143, H30670802BB31, H306708119072, H30670861DD7A, H30670872F639, H30670873E7B0, H306708758286, H30670876B01D, H3067088410C7, H30670889CB22, H30670903F064, H30670912F835, H3067091946E6, H30670940A59F, H30670949385E, H30670955EBEA, H306709681A67, H30670975D85A, H306709800C3F, H306709833EA4, H3067099236F5, H30671000425A, H3067100515F7, H306710141DA6, H30671028FDA2, H30671048A972, H3067105659D4, H306710623598, H3067106673BC, H306710700F52, H306710777BED, H30671083BE01, H30671095C2EF, H306711045EA2, H3067111110D7, H306711213ABF, 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H32526620ED80, H32526622CE92, H32526632D74A, H32526636916E, H32526654E6AC, H325266582CC0, H32526673A1A3, H32526704C2C8, H32526724F178, H32526736CBB2, H325267578EEB, H32526773FB7F, H32532425763D, H325324347E6C, H325324571827, H32532458E0D0, H32532463746B, H32532465115D, H325324750885, H325324858B4D, H32532487A85F, H325324894121, H32532491D4B1, H32532493F7A3, H32532496A00E, H327515253AE2, H327515307497, H3275153432B3, H32751538F8DF, H327515412816, H327515456E32, H327515502047, H327515546663, H32751558AC0F, H32751562293D, H32751571027E, H32751573216C, H3275157455D3, H327515776748, H32751582B32D, H32751587E480, H3275159089E7, H32751606D4AD, H32751617DCFC, H32751622A139, H32751625D586, H327516318A7A, H32751633A968, H3275163817BB, H32751642F5E9, H327516458156, H32751650CF23, H327516548907, H32751657BB9C, H32751662C659, H32751664A36F, H32751669788A, H32751674BAB7, H3275167870DB, H327516816ED2, H32751684397F, H327516924591, H327517097686, H32751711E316, H32751714B4BB, H327517196F5E, H32751726BDC1, H32751732E23D, H327517359682, H327517384D67, H32751742AF35, H327517629C85, H327517638D0C, H32751764F9B3, H32751774E06B, H32751775F1E2, H32751781340E, H3275178463A3, H327517921F4D, H327517930EC4, H32751799A19E, H32751805F62D, H32751810B858, H32751814FE7C, H32751823A0AB, H327518290FF1, H327518308BE8, H32751835DC45, H32751845914D, H32751846A3D6, H32751847B25F, H327518558895, H3275185942F9, H32751860F550, H3275186781EF, H32751870EC88, H32751871FD01, H327518779837, H3275187860C0, H327518842964, H32751909669D, H32751910E284, H32751911F30D, H32751931C0BD, H32751932F226, H327519385D7C, H327519394CF5, H32751944DA18, H3275195085E4, H32751952A6F6, H32751955D249, H32751957F15B, H327519639D17, H32751966CABA, H3275197384CF, H32751976D362, H32751980359C, H327519812415, H32751982168E, H32751988B9D4, H327519902C44, H327519920F56, H3275201369CC, H327520141D73, H32752020713F, H327520270580, H3275204025EF, H327520413466, H327520457242, H3276227284E1, H32762305E78A, H327623092DE6, H327623139B64, H32762322A085, H32762327F728, H32762339078E, H327623449163, H3276234580EA, H327623494A86, H32762353FC04, H3276236681C1, H32762375AA82, H327623825DF5, H32762385294A, H32762394211B, H327624003C22, H327743519FC8, H32774366C11F, H327743682861, H327743812FB0, H327744993625, H327745130D63, H32774525423D, H327745355BE5, H327745527B8A, H327745706B28, H327746048F60, H32774606AC72, H32774624BCD0, H327746397EED, H327746538567, H32774674C268, H327746910FD5, H32774706F6AE, H327747180608, H32774731A879, H32774744B2DC, H327747695A89, H327747827E4A, H3277479621B6, H32774811D10E, H32774829772E, H32774844F81B, H32774857D358, H32774865DA22, H327748790996, H327748944863, H327749080FCB, H32774924F617, H3277494681D5, H32774963E5C8, H32774977BA34, H3277499631AD, H327750066610, H327750132865, H32775019873F, H327750274429, H32775082EEF4, H3277508841AE, H327751050E57, H327751206A4A, H3277513616A4, H3277515136CB, H32775166681C, H3277517671C4, H32775186F20C, H32775202958C, H32775217DBF9, H327752318D7F, H32775246B4C8, H3277526796F1, H327752825B4C, H32775299FC47, H3277531879D2, H327753359187, H3277534916E3, H327753692553, H3277539309C1, H3277540714F8, H32775425045A, H3277544116AE, H327754523DED, H32775481BF0E, H32775519BE82, H3277553010F3, H327755450A56, H327755671AF4, H32775582D749, H327755997042, H32775647C620, H32775664C70B, H3277567814BF, H32775693307C, H3277570912E2, H32775721AD1A, H32945548F5DD, H3294557270EF, H32945579CE3C, H32945580D035, H32945586B503, H32945596ACDB, H32945610E849, H32945620C221, H329456284E69, H329456508F29, H32945657FB96, H3294570399D6, H32945710B295, H32945711A31C, H32945725CF50, H32945756B0C3, H32945788E9C5, H32945799E194, H32945801F003, H329458079535, H32945824941E, H329458258597, H32945830CBE2, H3294584086EA, H32945860B55A, H32945861A4D3, H32945876C9B4, H32945877D83D, H329458921580, H329458930409, H32945901AADF, H32945908371E, H32945916C7B8, H32945936F408, H329459449A12, H32945960EF86, H32945971E7D7, H3294597782E1, H32945998E006, H32946007763A, H329470727024, H329471733B71, H32947210B25E, H32947241DD6F, H329472696297, H32947320C2EA, H329473519E6B, H3294739137CB, H3294745445C3, H3294747567FA, H32947650B65F, H329476932D64, H32947810C124, H32947904C404, H32947963E46B, H32948017C1A0, H32948166C7FD, H32948215570A, H3294827503DA, H32948345736E, H32948422DF04, H329484538385, H32948477F611, H32948520A6CA, H32948695FAAB, H3295565195E4, H32955726F68F, H32955743F5F2, H3295575852F9, H329557835C52, H32955798FB59, H32955799EAD0, H32955805BD63, H329558079E71, H3295581787A9, H329558285536, H32955845DA03, H32955857E0C9, H32955861AF97, H329558638C85, H3295588750B1, H32955888A846, H329558921EC4, H32955907C4AD, H32955916CCFC, H32955927F71D, H329559280FEA, H329559485B3A, H329559494AB3, H32955959536B, H3295596681F4, H32955970FD1A, H32955971EC93, H3295597789A5, H32955989E313, H3295599713B5, H329560022AD3, H32956012330B, H329560189C51, H329560256DDC, H329560375716, H329560460B97, H329560507779, H329560627E03, H32956069C0D0, H3295607044C9, H32956078C881, H32956093EC42, H32956100531D, H32956109CEDC, H3295612243BF, H3295614125F4, H32956148B835, H32956149A9BC, H329561655060, H32956187E962, H329561881195, H329582144DC7, H329582166ED5, H32958246106D, H32958249E89A, H329582615762, H329582714EBA, H32958280DCFB, H329583026BF5, H329583335014, H3295833607B9, H32958352154D, H329583667901, H3295837660D9, H329583891BE6, H32958396FAC9, H32958417A985, H329584185172, H329584269264, H32958444E5A6, H32958445F42F, H329584529948, H32958456DF6C, H32958464D616, H32958467E48D, H329584719863, H32958488866A, H3295848997E3, H329584976745, H32958513B57D, H32958515D04B, H329585228E9C, H32958541E8D7, H32958542DA4C, H329644475DC5, H32964448A532, H32964449B4BB, H3296445030A2, H32964451212B, H3296445213B0, H329644530239, H329644547686, H32964455670F, H329644565594, H32964457441D, H32964458BCEA, H32964459AD63, H329644601ACA, H329644610B43, H3296446239D8, H329644632851, H329644645CEE, H329644654D67, H329644667FFC, H329644676E75, H329644689682, H32964469870B, H329644700312, H32964471129B, H329644722000, H329644733189, H329644744536, H3296447554BF, H329644766624, H3296447777AD, H329644788F5A, H329644799ED3, H3296448080DA, H329644819153, H32964482A3C8, H32964483B241, H32964484C6FE, H32964485D777, H32964486E5EC, H32964487F465, H329644880C92, H329644891D1B, H329644909902, H32964491888B, H32964492BA10, H32964493AB99, H32964494DF26, H32964495CEAF, H32964496FC34, H32964497EDBD, H32964498154A, H3296449904C3, H3296450014C6, H32964501054F, H3296450237D4, H32964503265D, H3296450452E2, H32964505436B, H3296450671F0, H329645076079, H32964508988E, H329645098907, H329645100D1E, H329645111C97, H329645122E0C, H329645133F85, H329645144B3A, H32969977035D, H32970007206C, H3297002713DC, H329700325DA9, H32970034389F, H329700447597, H329700502A6B, H329700564F5D, H3297007019DB, H329700710852, H329700789593, H32970079841A, H32970086FF25, H32970093B150, H329701011F86, H329701066B39, H329701077AB0, H3297010993CE, H3297011017D7, H330052762D78.

Where was it sold?

Foreign Distribution: Korea.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Philips Respironics

All 76

Reported	Class	Recall	Company	Reason	Where
8 Apr 2026Device	CLASS I	Trilogy Evo recalled by Philips Respironics	Philips Respironics	Device Malfunction	Nationwide
8 Apr 2026Device	CLASS I	Trilogy EV300 recalled by Philips Respironics	Philips Respironics	Device Malfunction	Nationwide
8 Apr 2026Device	CLASS I	Trilogy Evo Universal recalled by Philips Respironics	Philips Respironics	Device Malfunction	Nationwide
8 Apr 2026Device	CLASS I	Trilogy Evo O2 recalled by Philips Respironics	Philips Respironics	Device Malfunction	Nationwide
1 Apr 2026Device	CLASS I	Trilogy Evo recalled by Philips Respironics	Philips Respironics	Device Malfunction	Nationwide

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All 13,908

Reported	Class	Recall	Company	Reason	Where
14 Oct 2026Device	CLASS II	Plastics Tray kits recalled by Avid Medical	Avid Medical	Foreign Material	Nationwide
14 Oct 2026Device	CLASS II	Heart Prep Tray kits recalled by Avid Medical	Avid Medical	Other	Nationwide
14 Oct 2026Device	CLASS II	Pack Open Heart Cfh kits recalled by Avid Medical	Avid Medical	Other	Nationwide
14 Oct 2026Device	CLASS II	Sperm Ab Elisa (96 well plate test) recalled by DRG International	DRG International	Other	Nationwide
14 Oct 2026Device	CLASS III	BeneView Series recalled by Mindray DS USA	Mindray DS USA	Device Malfunction	Nationwide