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U.S. Department of Health and Human Services

Class 2 Device Recall Trilogy Evo

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  Class 2 Device Recall Trilogy Evo see related information
Date Initiated by Firm May 25, 2023
Date Posted July 07, 2023
Recall Status1 Open3, Classified
Recall Number Z-2106-2023
Recall Event ID 92515
510(K)Number K181166  
Product Classification Ventilator, continuous, facility use - Product Code CBK
Product Trilogy Evo, Evo Clinical Korean (1137823) and Evo Caregiver Korean (1137853) Instructions for Use
Code Information 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, H30683301EF3D, H3068330872FC, H30683314A148, H30683320CD04, H306833358371, H30683344DFF0, H30683355D7A1, H306833628976, H30683370B3BC, H30683403402A, H30683408FEF9, H30683419F6A8, H30683423739A, H306834262437, H306834327BCB, H306834363DEF, H30683447616E, H306862194E26, H30686266FBD9, H30686302B3F1, H306863282F1B, H3068633836C3, H30686353DCC0, H30686362E721, H3068637851A3, H306863915672, H30686398CBB3, H306864231DCD, H306864312707, H306864407B86, H306864640E12, H306865051197, H30686529E84B, H30686540215A, H3068654755E5, H306865722820, H30686584CEDE, H30686595C68F, H30686606CC68, H30686635D49B, H30686660FD8E, H30686664BBAA, H30686665AA23, H306866835505, H3068669529EB, H306866970AF9, H30686703C119, H30686715BDF7, H306867186612, H30686720C032, H30686722E320, H30686731C863, H306867349FCE, H30686737AD55, H30686742B7F0, H30686770BE8A, H30686775E927, H306867812CCB, H306867830FD9, H306867847B66, H306867865874, H30686789A083, H306867920788, H30686799B95B, H306868029A57, H30686804FF61, H30686807CDFA, H30686808350D, H30686816C5AB, H3068687780F2, H30686910FA41, H306869419570, H30686966D27F, H306869846B7D, H30687019E725, H30687029CD4D, H3068703158DD, H3068704336C7, H306870598045, H3068706214FE, H306870713FBD, H306870746810, H306871030B7B, H3068711312A3, H30689658E957, H30689967710F, H306900074BE6, H306900515068, H30690085A634, H30690107113A, H306901326CFF, H30696267E114, H306964374975, H306965623ABC, H30696840D561, H30699719CE26, H30699751250E, H307010327FD7, H30707660BF3E, H307140098E7F, H307193372982, H307193467503, H307193620097, H30719394E669, H307420892D71, H31226199AC53, H31227263731E, H312272727B4F, H31227280DB95, H31227293F0D6, H312273127543, H3122731722EE, H31227319CB90, H312273252B94, H31227329E1F8, H31227335324C, H31227397EC2E, H312274194795, H31227534F51C, H31227562EE92, H3122756841C8, H31227577A0E7, H31227587232F, H312276043010, H312276124CFE, H3122764323CF, H312276511905, H31227679A6FD, H312277031E73, H31227708A0A0, H31227719A8F1, H3122772548F5, 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, 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, H31248798FED9, H31248799EF50, H31248800EF4E, H31248801FEC7, H31248802CC5C, H31248803DDD5, H31248804A96A, H31248805B8E3, H312488068A78, H312488079BF1, H312488086306, H31248809728F, 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, 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H3297011017D7, H330052762D78.
Recalling Firm/
Manufacturer		 Philips Respironics, Inc.
1001 Murry Ridge Ln
Murrysville PA 15668-8517
For Additional Information Contact Philips Customer Service
800-345-6443
Manufacturer Reason
for Recall		 There are errors present in the Korean Instructions For Use where the word "invasive," was incorrectly translated to "noninvasive".
FDA Determined
Cause 2		 Under Investigation by firm
Action Customers were mailed a recall notification dated 05/23/2023 identifying the reason for recall as a mistranslation from "invasive" to "non-invasive" in the Korean IFUs. Customers are to refer to the correct instructions as listed in the recall notification when referring to the updated IFU pages, keep a copy of the recall notification with the IFU, communicate the recall notification to all who need to be aware in their organization, and complete and return the provided Field Safety Notice Response Form. The response form can be returned to the Philips representative indicated in your specific recall notification.
Quantity in Commerce 1,581 units
Distribution Foreign Distribution: Korea.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = CBK and Original Applicant = Respironics Inc.
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