Recall archive / FDA device enforcement

Trilogy Evo, Evo Clinical Korean (1137823) and Evo Caregiver Korean (1137853) Instructions for Use — FDA record Z-2106-2023

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 25, 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, Evo Clinical Korean (1137823) and Evo Caregiver Korean (1137853) Instructions for Use
Reason: There are errors present in the Korean Instructions For Use where the word "invasive," was incorrectly translated to "noninvasive".
Classification: Class II
Recalling firm: Philips Respironics, Inc.
Quantity: 1,581 units
Agency-reported status: Ongoing
Source record identifier: Z-2106-2023

Open the official record

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	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, H30678567A2EB, H306785837EDF, H306786205E50, H30678632649A, H306786422992, H30678656766E, H306786647F14, H306786731273, H30678678ACA0, H30678687D79F, H30678694FCDC, H306787056091, H306787157949, H30678748DC14, H30678758C5CC, H306787635177, H306788025EE9, H3067881356B8, H306788215FC2, H30678837232C, H306788476E24, H306788566675, H306788646F0F, H30678880B33B, H3067889289F1, H306789020435, H30678908AB6F, H3067891478DB, H306789201497, H3067892671A1, H306789366879, H30678981F86E, H306789897426, H30678995A792, H306789978480, H306789987C77, H30679001B60B, H306790028490, H30679004E1A6, H30679006C2B4, H306790093A43, H3067902185BB, H306790319C63, H30679045974F, H3067906787ED, H306790779E35, H306790860C74, H3067909615AC, H30679109609F, H30679122EDFC, H30679130D736, H306791385B7E, H30679147EE81, H30679151926F, H30679166CCB8, H30683210BDB0, H30683215EA1D, H30683223A543, H306832281B90, H306832380248, H30683251CB59, H30683264B69C, H30683272CA72, H3068327974A1, H306832943554, 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H3122773663B6, H312277451C25, H31227758DE18, H31227769E5F9, H31227777155F, H31227784A40C, H31227785B585, H31227786871E, H312277879697, H312278315DCE, H31227838C00F, H312278499C8E, H312278702B27, H31227884EECB, H31227908B0BB, H31227914630F, H312279389AD3, H312279436908, H3122796179AA, H312279671C9C, H3122797437DF, H31227985A59E, H31228003208F, H312280089E5C, H312280155C61, H31228023133F, H3122803129F5, H3122804522D9, H312280524FBE, H312280651169, H31228069DB05, H31228086B9E2, H31228090C50C, H312280948328, H312280984944, H312281026BDA, H312281040EEC, H31228108C480, H312313453F9A, H31231358FDA7, H31231369C646, H31231374047B, H312313985407, H31231403B1C9, H31231406E664, H31231412B998, H31231421A16B, H31231426D5D4, H31231430A93A, H31231434EF1E, H31231441F5BB, H31231445B39F, H31231450FDEA, H3123145698DC, H3123146491A6, H312314694A43, H31231472ED48, H31231474887E, H312314804D92, H312314837F09, H31231488C1DA, H31231500D98E, H31231502FA9C, H31231507AD31, H312315148672, H31231517B4E9, 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H31248810F696, H31248811E71F, H31248812D584, H31248813C40D, H31248814B0B2, H31248815A13B, H3124881693A0, H312488178229, H312488187ADE, H312488196B57, H31248820DCFE, H31248821CD77, H31248822FFEC, H31248823EE65, H312488249ADA, H312488258B53, H31248826B9C8, H31248827A841, H3124882850B6, H31248829413F, H31248830C526, H31248831D4AF, H31248832E634, H31248833F7BD, H312488348302, H31248835928B, H31248836A010, H31248837B199, H31248838496E, H3124883958E7, H31248840882E, H3124884199A7, H31248842AB3C, H31248843BAB5, H31248844CE0A, H31248845DF83, H31248846ED18, H31248847FC91, H312488480466, H3124884915EF, H3124885091F6, H31248851807F, H31248852B2E4, H31248853A36D, H31248854D7D2, H31248855C65B, H31248856F4C0, H31248857E549, H312488581DBE, H312488590C37, H31248860BB9E, H31248861AA17, H31248862988C, H312488638905, H31248864FDBA, H31248865EC33, H31248866DEA8, H31248867CF21, H31658332D47A, H316583387B20, H31658341ABE9, H3165834388FB, H31658346DF56, H31658350A3B8, H3165835280AA, H31658354E59C, H316583582FF0, H316583619859, H31658363BB4B, H317409371A1A, H317409512BFC, H317409565F43, H31740960101D, H317409777D7A, H31740982A91F, H31740986EF3B, H317409880645, H31740992B0C7, H31740996F6E3, H31741000C468, H3174100593C5, H3174100959A9, H317410149B94, H31741020F7D8, H317410296A19, H31741033DC9B, H3174103973C1, H317410439193, H317410482F40, H31741053884B, H31741055ED7D, H317410592711, H31741063A223, H3174107198E9, H31741075DECD, H31741077FDDF, H317410833833, H317410877E17, H317410923062, H317410967646, H317411018F3D, H31741106FB82, H3174111196E5, H317411228E16, H31741127D9BB, H31741130B4DC, H31741135E371, H317411469CE2, H31741150E00C, H317411586C44, H317411597DCD, H317411648C40, H31741171C235, H317411749598, H317411827366, H317411863542, H31741189CDB5, H317411951E01, H31741199D46D, H317442067AB1, H317442076B38, H3174421117D6, H3174421772E0, H317442231EAC, H31744229B1F6, H3174423473CB, H317442443EC3, H317442470C58, H3174425170B6, H31961563B4B4, H3196163017F3, H319616635BD0, H3196167615A5, H31961680F35B, H319617024455, H319617060271, H319617444603, H319617499DE6, H319617775EF0, H31961786CCB1, H31961808A1C8, H319618223D22, H319618399A29, H319618670DEF, H31961880E340, H319619124D96, H3196192267FE, H31961951186D, H32000923DC49, H320009539141, H32000964CF96, H32000972B378, H32000981022B, H320009898E63, H320009977EC5, H320010027ED5, H320010072978, H320010334534, H320010370310, H320010412B2E, H32001050237F, H320010564649, H320010677DA8, H3200107675F9, H320010919B56, H32001106622D, H320011198302, H3200114171F2, H320011534B38, H3200116270D9, H320011737888, H32001196B535, H32003231EAE8, H32003241A7E0, H32053747DD3F, H320537493441, H32053762B922, H32053764DC14, H320537681678, H320537945FDC, H320538008427, H3205380195AE, H320538109DFF, H320538339CD4, H32053834E86B, H32053835F9E2, H32053836CB79, H32053860D0F7, H32053861C17E, H320538694D36, H32053870C92F, H32053900DEFB, H32053907AA44, H32053915908E, H32053916A215, H32053937802C, H32053949245A, H32053957D4FC, H320539582C0B, H32108010B957, H32108011A8DE, H321080129A45, H32108014FF73, H32108016DC61, H32108017CDE8, H321080192496, H32108020933F, H32108023A1A4, H32108024D51B, H32108027E780, H321080308AE7, H32108033B87C, H32108036EFD1, H32108040C7EF, H3210804481CB, H321080459042, H32108051CFBE, H32108052FD25, H32108053ECAC, H32108055899A, H32108056BB01, H32108058527F, H3210805943F6, H32108060F45F, H321470405806, H3214705041DE, H3214705624E8, H321470606BB6, H321470642D92, H3214707163E7, H3214707340F5, H32147078FE26, H32147083C33D, H321470887DEE, H32147090E87E, H32147093DAE5, H321470979CC1, H321470986436, H3214709975BF, H3214710065BA, H321471017433, H3214710246A8, H321471035721, H32147104239E, H3215426695B1, H321542696D46, H32154271F8D6, H32154273DBC4, H32154275BEF2, H321919814BDF, H32192019A95C, H321920344109, H321920426937, H3219205415D9, H321920670D2A, H3219207352D6, H32192090FA5D, H32192091EBD4, H32192122673B, H3219214010F9, H321921838BC2, H32192184FF7D, H321921928393, H32193208080E, 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H322953841199, H32295404535C, H322954231453, H322954434083, H32295466249E, H32295481CA31, H322955040980, H322955216D9D, H32295538E984,...

Label field

Details supplied by the agency

Lot, code or applicability

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, 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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

Foreign Distribution: Korea.

No US distribution state could be established from this record. Check the official notice.

Dates in the source

Report date: Jul 12, 2023
Recall initiation date: May 25, 2023
Center classification date: Jul 6, 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.

What the record says

Lot and product identifiers

Distribution

Dates in the source

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