--- title: "Trilogy Evo, Evo Clinical Korean (1137823) and Evo Caregiver Korean (1137853)... — FDA record Z-2106-2023 | Is It on Recall" description: "There are errors present in the Korean Instructions For Use where the word \"invasive,\" was incorrectly translated to \"noninvasive\"." url: https://isitonrecall.com/recall/fda-device-z-2106-2023-trilogy-evo-evo-clinical-korean-1137823-and-evo-caregiver-korean-1137853-instructions-for-use/ updated: 2026-10-01 site: "Is It on Recall" language: en --- [Recall archive](https://isitonrecall.com/archives/) / 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](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/). ## 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](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2106-2023%22) [What the recall classes mean](https://isitonrecall.com/guides/recall-classes/). 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, 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H3123146491A6, H312314694A43, H31231472ED48, H31231474887E, H312314804D92, H312314837F09, H31231488C1DA, H31231500D98E, H31231502FA9C, H31231507AD31, H312315148672, H31231517B4E9, H31248710BC51, H31248711ADD8, H312487129F43, H312487138ECA, H31248714FA75, H31248715EBFC, H31248716D967, H31248717C8EE, H312487183019, H312487192190, H312487209639, H3124872187B0, H312487308FE1, H31248733BD7A, H31248734C9C5, H31248735D84C, H31248736EAD7, H31248737FB5E, H3124873803A9, H312487391220, H31248740C2E9, H31248741D360, H31248742E1FB, H31248743F072, H31248752F823, H31248753E9AA, H312487549D15, H312487558C9C, H31248756BE07, H31248757AF8E, H312487585779, H3124875946F0, H31248760F159, H31248770E881, H31248771F908, H31248772CB93, H31248773DA1A, H31248774AEA5, H31248775BF2C, H312487768DB7, H3124877864C9, H31248782485B, H312487860E7F, H312487871FF6, H31248788E701, H31248789F688, H312487907291, H312487916318, H312487925183, H31248793400A, H3124879434B5, H31248795253C, H3124879617A7, H31248797062E, 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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, 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H322941869B88, H32294203ED81, H322952048585, H32295233DB52, H32295255EAB4, H322952708EA9, H322952855ACC, H32295307EDC2, H3229532289DF, H32295343CC86, H32295355B068, H32295370D475, H322953841199, H32295404535C, H322954231453, H322954434083, H32295466249E, H32295481CA31, H322955040980, H322955216D9D, H32295538E984,... | The agency lot list is longer than this excerpt. [Read the complete list at the official source](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2106-2023%22). 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 to do next Read the official notice for the action that applies to your exact product. [Read the current instructions](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2106-2023%22) ## Related records [Medical devices records](https://isitonrecall.com/category/medical-devices/) [Philips Respironics, Inc. records](https://isitonrecall.com/brand/philips-respironics-inc/)