Recall archive / FDA device enforcement

Trilogy EV300 Portable Electric Ventilator, Model Numbers DS2200X11B, IN2200X15B, FX2200X15B, CA2200X12B, CN2200X17B,... — FDA record Z-1288-2023

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 Mar 1, 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 EV300 Portable Electric Ventilator, Model Numbers DS2200X11B, IN2200X15B, FX2200X15B, CA2200X12B, CN2200X17B, BR2200X18B, KR2200X15B, IA2200X15B, FR2200X14B, ND2200X15B, IT2200X21B, ES2200X15B, DE2200X13B, BL2200X15B, GB2200X15B, EU2200X15B, EU2200X19, EE2200X15B, TR2200X15B, RU2200X15B
Reason: The accuracy of delivered oxygen may deviate below the required tolerance of 5% from setpoint when providing high concentration oxygen therapy. Additionally, if equipped, the internal FiO2 sensor may indicate a value higher than the device is actually delivering. This may lead to under delivery of oxygen.
Classification: Class I
Recalling firm: Philips Respironics, Inc.
Quantity: 62826 total devices
Agency-reported status: Ongoing
Source record identifier: Z-1288-2023

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	UDI-DI: 606959052017, 606959056497, 606959061033, 606959052321, 606959058613, 606959058620, 606959058644, 606959058668, 606959058675, 606959058682, 606959058705, 606959058798, 606959052000. UDI-DI, Model number: Serial numbers 606959052017, DS2200X11B: H27990931E388, H27990933C09A, H27990934B425, H279909369737, H28068115E37D, H28068117C06F, H28086487E130, H280912810EBA, H28091329255E, H280914614273, H28091549A757, H28091634DEDE, H28091674B9BE, H280918082EC1, H280918779B3E, H28091945C898, H28092332A798, H2809235587F7, H28092419A6FE, H280924344EAB, H280924473138, H28092465219A, H280924717E66, H28092478E3A7, H28092499683E, H2809251427C7, H280925341477, H280925522591, H280925631E70, H28092614C8A3, H28096497F3AC, H280964991AD2, H280965000AD7, H280965011B5E, H2809650229C5, H28096503384C, H280965044CF3, H280965055D7A, H280965066FE1, H280965077E68, H28270803E547, H28270834BB90, H28270854EF40, H28270873A84F, H282708832B87, H28270893325F, H28270902AE12, H28270921AF39, H282709382B20, H282709468F56, H28270960D9D0, H28270971D181, H282710044B81, H282710230C8E, H282710274AAA, H2827103027CD, H2827103642FB, H2827104249D7, H282710516294, H2827105707A2, H28271078CCE5, H28271082E077, H282710895EA4, H282710958D10, H28271104115D, H2827110723C6, H282744145F6F, H282791971106, H2828022698DC, H283571110611, H28357128B1B8, H28357134620C, H283833769D5E, H283833778CD7, H283833787420, H283833807BA0, H283833843D84, H283834175402, H28383418ACF5, H28383419BD7C, H28383432301F, H283834332196, H2838343544A0, H2838343767B2, H283834389F45, H283834405E05, H283834427D17, H2838345047DD, H2838345264CF, H2838345622EB, H283834573362, H28383458CB95, H283834635F2E, H283834660883, H28383472577F, H28383478F825, H28383484B181, H28383491FFF4, H2840965179B3, H28409679C64B, H28409680D842, H28409683EAD9, H2840972439CA, H284097324524, H284097360300, H284097402B3E, H2840974319A5, H2840975032E6, H2840975474C2, H2840975657D0, H28409760188E, H284097667DB8, H284097744772, H28409780829E, H284098099B58, H284098198280, H284098203529, H28422934E694, H2842311158F0, H28426246D3C4, H28426257DB95, H284263382D6E, H2842646415BF, H284264650436, H2842646636AD, H284264740C67, H284264762F75, H284264773EFC, H28426478C60B, H28426480C98B, H284264859E26, H28426486ACBD, H2842648845C3, H28426491C1DA, H28426492F341, H28426493E2C8, H284264949677, H2842649587FE, H28426496B565, H28426497A4EC, H284264985C1B, H284264994D92, H284265005D97, H284265027E85, H284465362951, H2844654333F4, H2844655018B7, H284465567D81, H284465882487, H28446594F733, H296722202119, H3311009663E8, H33113033ECF8, H288916282C32, H2889206563A3, H336070827CA0, H338358141554, H3353772568DB, H33696423BEE7, H338247100E48, H33952123BF0F, H33952148550C, H277504071D3B, H277504598AFD, H2775061483C0, H27750906F3CD, H277511623B40, H29472115BBEE, H2954061040D7, H29540655701A, H2954070445F7, H295408909E0C, H295877717F43, H295881689F7A, H2958819090FA, H29588192B3E8, H29588195C757, H29591208D6E9, H28130975B6C8, H28274405573E, H28274559B936, H28277529D1F3, H2827753055EA, H282775336771, H282775350247, H2827753630DC, H282775467DD4, H2827755333A1, H28277556640C, H282775602B52, H28277570328A, H2827757657BC, H28277580B142, H28277586D474, H282775892C83, H28277591B913, H282775928B88, H28277597DC25, H28277607E459, H28277612AA2C, H28277621B2DF, H2827762391CD, H282776282F1E, H2838646666D4, H283954602D6B, H283955333B94, H28396414038A, H2841393282D5, H2867243437E9, H286998412942, H287150343C1A, H287624745FE6, H287624818B83, H28762491925B, H287624991E13, H287625011F9F, H2876251451EA, H287625198A0F, H287625247B82, H287625274919, H2876254178FF, H287625460C40, H28762548E53E, H287625534235, H2876257514B3, H28762585977B, H287625884C9E, H28762597ADB1, H28762630CB1A, H28762631DA93, H28762632E808, H28762636AE2C, H2876263956DB, H28762642A500, H28762644C036, H28762646E324, H28762652BCD8, H287651660BB0, H28767205BBE9, H28767227AB4B, H28767233F4B7, H287672518375, H287672629B86, H28794675DAB1, H28818011EE01, H2902840571DD, H29032098C9AB, H290328513B08, H29033189879D, H290332301190, H29033657529E, H290338353547, H29034112B977, H29034149791C, H290394301BE7, H2903944275FD, H290394562A01, H2903946357C4, H2903946711E0, H290394734E1C, H290394752B2A, H2903947619B1, H29039494A0B3, H290395017ADA, H290395603F83, H29039741A802, H29039780102B, H29039816E8C2, H290398392385, H29039841E2C5, H29039845A4E1, H29039852C986, H29039853D80F, H29039855BD39, H290398597755, H290398814B65, H29040791D1C5, H29041106B800, H2904111482CA, H290411159343, H29041116A1D8, H2904111848A6, H29041119592F, H29041120EE86, H29041122CD94, H29041123DC1D, H290411268BB0, H29041133C5C5, H29041134B17A, H29041147CEE9, H29041175C793, H2904120123DB, H290422257382, H290422434264, H29042273680C, H290423037FD8, H290423040B67, H29042309D082, H290423353086, H29042359AE3A, H290423667CA5, H290423698452, H29042421E37F, H29042466F0A0, H2904249762E1, H290425282462, H290425915D0B, H29042658860E, H2904268927FF, H29042730044A, H290428983FB5, H29042917535E, H290429441F7D, H290429463C6F, H29042969F728, H29043120D7F0, H290431820992, H290432022836, H290432203894, H290432417DCD, H29043571DBA0, H290435873D5E, H290435950794, H29043596350F, H290435972486, H290436024B57, H290436071CFA, H2904361614AB, H2904363370B6, H290436411EAC, H290436477B9A, H29043670254D, H290436746369, H29043696DA6B, H290437056534, H290437146D65, H2904372110A0, H290456165F31, H290456355E1A, H290456399476, H29055124D10A, H290551290AEF, H290571794D21, H2905754815A1, H29057561BBD0, H2906923976AB, H2906924394F9, H290693785A9E, H290693926FD4, H29069398C08E, H290694010652, H290694133C98, H290694177ABC, H2906942135E2, H2906942573C6, H29069426415D, H29069428A823, H290694312C3A, H290694321EA1, H290694330F28, H29071279FF57, H29071280E15E, H290712868468, H2907128795E1, H290712886D16, H29071293CA1D, H29071294BEA2, H290713007542, H290713025650, H290713043366, H2907130701FD, H29071498A217, H29071499B39E, H290810729EC0, H29082691C55F, H29082696B1E0, H29082698589E, H290826994917, H29082701489B, H290827050EBF, H29082708D55A, H290827115143, H290827137251, H2908271406EE, H29082719DD0B, H290827206AA2, H290827217B2B, H2908272249B0, H290827235839, H290827253D0F, H290827260F94, H29082728E6EA, H29082729F763, H2908273162F3, H2908273341E1, H2908273524D7, H29082749A3B3, H290827513623, H2908275204B8, H290827531531, H290827557007, H290827575315, H29082758ABE2, H29082759BA6B, H290827600DC2, H290827622ED0, H290827633F59, H290827644BE6, H290827655A6F, H2908276668F4, H29082767797D, H29082768818A, H29082770141A, H290827710593, H290827723708, H2908277989DB, H29082783A549, H29082784D1F6, H29082785C07F, H29082793BC91, H29082797FAB5, H290827980242, H2908279913CB, H29082801025C, H29082803214E, H290828054478, H2908280676E3, H29082807676A, H290828089F9D, H290828098E14, H290828111B84, H290828166F3B, H290828177EB2, H290828188645, H29092792A65C, H29094368A235, H29094453BA8B, H290944682E30, H29094474FD84, H29094551C345, H29094574A758, H29094581733D, H29094589FF75, H290946040534, H29094619C709, H2909467559B5, H29094686E8E6, H290947045FE8, H290947246C58, H290947407EAC, H290947604D1C, H290948546B97, H290948723D11, H29094887E974, H290949247C43, H29094939BE7E, H2909497402FB, H290949848133, H290949985287, H29095013A231, H29095026DFF4, H290950339181, H29095035F4B7, H29095042CD00, H29095054B1EE, H2909506851EA, H2909507593D7, H290950840196, H29095088CBFA, H29095106B698, H29095112E964, H29095138758E, H29095144F2EA, H290951539F8D, H2909515930D7, H290951680B36, H2909632704D4, H29096401DE57, H29096409521F, H290964185A4E, H29096430E5B6, H290964439A25, H29096445FF13, H290964592CA7, H2909646906CF, H29096508194A, H290965293B73, H29096542D170, H29096565967F, H290965814A4B, H290966070ED9, H290966237B4D, H2909667743D1, H290967103962, H290967300AD2, H290967366FE4, H2909674047DA, H290967505E02, H290967541826, H2909675509AF, H290967724EA0, H29096780EE7A, H2909678973BB, H290967987BEA, H29096828D585, H2909684990DC, H29096868B2E5, H29096908BCE9, H290969175DC6, H2909692777AE, H290969345CED, H29096943655A, H29096959D3D8, H290969725EBB, H291027230632, H29102746054F, H291027762F27, H29102792F313, H291028051A73, H291028207E6E, H29102859AEA7, H291028689546, H29102880831E, H29102901068B, H291029330FF1, H2910294704DD, H291029560C8C, H29102981C84B, H29102991D193, H29103002B4B5, H291032377CC8, H29103298794F, H291033124209, H291033939D40, H29103401E54F, H29103431CF27, H29103434988A, H2910344093A6, H29103443A13D, H29103640261E, H2910365479E2, H29103683BD25, H29103692B574, H29103823504E, H291039265D3F, H291039442AFD, H29103978CAF9, H29104023C1AD, H29104035BD43, H291040482BAE, H291040989BD6, H291041009A5A, H29104107EEE5, H2910418631AC, H29104189C95B, H291052071D3A, H29105209F444, H29105250173D, H29105272079F, H29105286C273, H291054458F91, H29105462C89E, H29105556FE0E, H29105632039E, H291057050795, H29105719D421, H29105858E80F, H29111783D5CB, H291118444213, H29111880AD97, H29111900398B, H291119012802, H291119030B10, H291119047FAF, H291119065CBD, H29111908B5C3, H29111909A44A, H2911191131DA, H291119120341, H2911191312C8, H291119146677, H2911191577FE, H291119164565, H2911191754EC, H29111918AC1B, H29111919BD92, H291119277E84, H2911192997FA, H2911193013E3, H29111931026A, H2911193230F1, H291119332178, H2911193676D5, H29111937675C, H291119389FAB, H291119427DF9, H291119450946, H29111948D2A3, H29111949C32A, H2911195156BA, H2911195375A8, H29111955109E, H291119562205, H29111959DAF2, H291119653AF6, H2911196719E4, H29111968E113, H29111969F09A, H291119734618, H29111975232E, H29111977003C, H29111979E942, H29111980F74B, H291209047ED8, H291209200B4C, H29120929968D, H291209427C8E, H291209635EB7, H29120979E835, H29120984B018, H291209896BFD, H291209979B5B, H29121005EFF4, H291210083411, H29121011B008, H29121013931A, H29121016C4B7, H291246364F89, H29124648EBFF, H291247412CE2, H291249270D1F, H29124954728C, H291249601EC0, H2912497550B5, H291249909D08, H291250059D18, H29125017A7D2, H29125030E0DD, H29125045FA78, H29125076E28B, H291250954A00, H29125105C7C4, H29125106F55F, H29125117FD0E, H2912512280CB, H29125137CEBE, H29125143C592, H29125151FF58, H291251568BE7, H29125160C4B9, H29125172FE73, H29125176B857, H291251872A16, H29125512C9C2, H29125520C0B8, H29125527B407, H2912556284CA, H291255639543, H29125564E1FC, H29125565F075, H29125566C2EE, H29125567D367, H291255682B90, H291255693A19, H29125570BE00, H29125571AF89, H291255729D12, H291255738C9B, H29125574F824, H291255783248, H2912557923C1, H291255830F53, H291255856A65, H29125589A009, H29125593168B, H291256023F7E, H2912561005B4, H291256144390, H2912561889FC, H291256220CCE, H291256264AEA, H291256303604, H29125633049F, H29125639ABC5, H29125648F744, H29125651735D, H29125657166B, H29125659FF15, H291256673C03, H291256727276, H2912567506C9, H29125680D2AC, H29125692E866, H29125698473C, H291257015739, H291257225612, H29125723479B, H2912572522AD, H291257261036, H2912572701BF, H29125728F948, H29125729E8C1, H291257306CD8, H2912574644E6, H291257512981, H291257565D3E, H29125759A5C9, H291257623172, H2912576545CD, H2912576766DF, H291257733923, H2912577887F0, H291257808870, H29125783BAEB, H29125787FCCF, H29125792B2BA, H29125795C605, H291257990C69, H291258011DFE, H2912580778C8, H29125808803F, H291258154202, H291258212E4E, H291262115291, H291262253EDD, H291262271DCF, H29126247491F, H2912625135F1, H291263507EA4, H29126358F2EC, H291263614545, H2912636277DE, H291263636657, H2912636412E8, H291263650361, H291263672073, H29126369C90D, H29126381DF55, H2912638488F8, H29126389531D, H29126402AF0B, H2912641095C1, H291264229CBB, H291264393BB0, H29126451E328, H29126461C940, H29126473F38A, H291264815350, H29126488CE91, H291264914A88, H29126498D749, H29126502F5D7, H29126507A27A, H29126513FD86, H291265148939, H29126531ED24, H2912654292B7, H29126550A87D, H291265709BCD, H29126757697A, H29126778A23D, H291268103062, H291268223918, H291268289642, H29126837776D, H291268527410, H291268634FF1, H2912687247A0, H29126879F973, H291269025074, H29126908FF2E, H291269153D13, H2912692625E0, H291269401406, H29126948984E, H2912696027B6, H291269774AD1, H291270628401, H29127141DFF6, H29127175B3BA, H2912731552D2, H29127329B2D6, H291273374270,...

Label field

Details supplied by the agency

Lot, code or applicability

UDI-DI: 606959052017, 606959056497, 606959061033, 606959052321, 606959058613, 606959058620, 606959058644, 606959058668, 606959058675, 606959058682, 606959058705, 606959058798, 606959052000. UDI-DI, Model number: Serial numbers 606959052017, DS2200X11B: H27990931E388, H27990933C09A, H27990934B425, H279909369737, H28068115E37D, H28068117C06F, H28086487E130, H280912810EBA, H28091329255E, H280914614273, H28091549A757, H28091634DEDE, H28091674B9BE, H280918082EC1, H280918779B3E, H28091945C898, H28092332A798, H2809235587F7, H28092419A6FE, H280924344EAB, H280924473138, H28092465219A, H280924717E66, H28092478E3A7, H28092499683E, H2809251427C7, H280925341477, H280925522591, H280925631E70, H28092614C8A3, H28096497F3AC, H280964991AD2, H280965000AD7, H280965011B5E, H2809650229C5, H28096503384C, H280965044CF3, H280965055D7A, H280965066FE1, H280965077E68, H28270803E547, H28270834BB90, H28270854EF40, H28270873A84F, H282708832B87, H28270893325F, H28270902AE12, H28270921AF39, H282709382B20, H282709468F56, H28270960D9D0, H28270971D181, H282710044B81, H282710230C8E, H282710274AAA, H2827103027CD, H2827103642FB, H2827104249D7, H282710516294, H2827105707A2, H28271078CCE5, H28271082E077, 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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

Worldwide distribution. US Nationwide including Puerto Rico, and countries of AE, AR, AT, AU, BD, BE, BG, BO, BR, CA, CH, CL, CN, CO, CZ, DE, DK, EC, EE, EG, ES, FI, FR, GB, GE, GT, HK, HR, HU, ID, IL, IE, IN, IT, JP, KW, LB, LT, MM, MQ, MX, MY, NG, NL, NO, NP, NZ, PE, PF, PH, PK, PL, PT, QA, RO, RS, RU, SA, SG, SI, SK, TH, TR, TW, UA, VN, and ZA.

States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.

Dates in the source

Report date: Apr 12, 2023
Recall initiation date: Mar 1, 2023
Center classification date: Apr 3, 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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