Trilogy Evo EV300 -- Model Number/ Model Description: BL2200X15B Trilogy Evo, O2, Benelux EV300; BR2200X18B Trilogy Evo, O2, Brazil EV300; CA2200X12B Trilogy Evo, O2, Canada EV300; DE2200X13B Trilogy Evo, O2, Germany EV300; DS2200X11B Trilogy Evo, O2, USA EV300; DS2200X11B Trilogy Evo, O2, USA EV300; EE2200X15B Trilogy Evo, O2, Eastern Europe EV300; ES2200X15B Trilogy Evo, O2, Spain EV300; EU2200X15B Trilogy Evo, O2, EU EV300; FR2200X14B Trilogy Evo, O2, France EV300; FX2200X15B Trilogy Evo, O2, INT EV300; GB2200X15B Trilogy Evo, O2, Great Britain EV300; IN2200X15B Trilogy Evo, O2, INTL EV300; IT2200X21B Trilogy Evo, O2, Italy EV300; KR2200X15B Trilogy Evo, O2, Korea EV300; ND2200X15B Trilogy Evo, O2, Nordics EV300; TR2200X15B Trilogy Evo, O2, Turkey EV300;

Class I - Dangerous

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    Model / UDI-DI: Trilogy Evo, O2, Benelux EV300 606959058668; Trilogy Evo, O2, Brazil EV300 606959058583; Trilogy Evo, O2, Canada EV300 606959052321; Trilogy Evo, O2, Germany EV300 606959058651; Trilogy Evo, O2, USA EV300 606959052017; Trilogy Evo, O2, USA EV300 606959052017; Trilogy Evo, O2, Eastern Europe EV300 606959058705; Trilogy Evo, O2, Spain EV300 606959058644; Trilogy Evo, O2, EU EV300 606959058682; Trilogy Evo, O2, France EV300 606959058613; Trilogy Evo, O2, INT EV300 606959061033; Trilogy Evo, O2, Great Britain EV300 606959058675; Trilogy Evo, O2, INTL EV300 606959056497; Trilogy Evo, O2, Italy EV300 606959058637; Trilogy Evo, O2, Korea EV300 606959058590; Trilogy Evo, O2, Nordics EV300 606959058620; Trilogy Evo, O2, Turkey EV300 606959058798; US Serial Numbers: H284098132DDA H284098302CF1 H33497881D1CB H33497883F2D9 H33497890D99A H334979140BA2 H358294978811 H35830133F8DF H35830506E67B H35830557894A H358305795384 H35830750484D H29713003B682 H297748223EC0 H28409798170E H28409822163B H284098331E6A H28409838A0B9 H284098417070 H2840984427DD H337553143AE3 H337559067353 H337559303C0D H2968179381A6 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 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H29096430E5B6 H29096445FF13 H290964592CA7 H2909646906CF H290965293B73 H29096542D170 H29096565967F H290965814A4B H290966070ED9 H290966237B4D H2909667743D1 H290967103962 H290967366FE4 H290967505E02 H290967724EA0 H29096959D3D8 H291027230632 H29102746054F H291027762F27 H29102792F313 H291028051A73 H291028207E6E H29102859AEA7 H291028689546 H29102880831E H29102901068B H291029330FF1 H2910294704DD H291029560C8C H29102981C84B H29102991D193 H29103002B4B5 H291032377CC8 H29103298794F H291033124209 H291033939D40 H29103401E54F H29103431CF27 H29103692B574 H29105286C273 H29105556FE0E H29105632039E 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 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H2920394060A4 H292039460592 H29203959E4BD H292039773E73 H29203988454C H29204001DD72 H29204011C4AA H292040954C4E H2920410187AE H29204104D003 H29204112ACED H29204113BD64 H292041383007 H29204144B763 H29204150E89F H29204151F916 H29204152CB8D H29204155BF32 H292041568DA9 H292041579C20 H2920415864D7 H29204159755E H29204160C2F7 H29204161D37E H29204162E1E5 H29204163F06C H2920416484D3 H29204165955A H29204166A7C1 H29204167B648 H292041684EBF H292041695F36 H29204170DB2F H29204171CAA6 H29204172F83D H292041749D0B H292041758C82 H29204176BE19 H292041785767 H2920417946EE H29204181496E H292041827BF5 H292041836A7C H292041841EC3 H292041850F4A H292041863DD1 H292041872C58 H29204188D4AF H29204189C526 H29204190413F H2920419150B6 H29204192622D H292041951692 H292041962409 H292041973580 H29204198CD77 H29204199DCFE H292042007943 H2920420168CA H292042025A51 H292042061C75 H292042117112 H292042237868 H29204228C6BB H2920423361B0 H29204238DF63 H292042432CB8 H29204248926B H292042533560 H2920425441DF H292042599A3A H292042646BB7 H29204269B052 H29204274726F H29204280B783 H29204287C33C H292042892A42 H29204297DAE4 H29204302008D H292043075720 H29204308AFD7 H2920431308DC H29204322333D H292043267519 H29204331187E H292043366CC1 H292043473040 H292043527E35 H292043572998 H292043735C0C H2920437428B3 H29204379F356 H29204410B642 H29204411A7CB H292044129550 H2920441384D9 H29204414F066 H29204416D374 H29204425CB87 H292044281062 H29204432A6E0 H29204437F14D H29204446ADCC H29204449553B H29204453E3B9 H292044594CE3 H29204464BD6E H292044669E7C H29204472C180 H29204474A4B6 H292044797F53 H29204484277E H2920448715E5 H292044925B90 H292044961DB4 H292045069070 H29204508790E H29204513DE05 H29204515BB33 H29204520C6F6 H29204522E5E4 H29204525915B H29204530DF2E H29204531CEA7 H29204546F710 H292045490FE7 H292045508BFE H292045519A77 H29204552A8EC H29204553B965 H29204557FF41 H2920455807B6 H29204560A196 H29204563930D H292045682DDE H292045729B5C H29204574FE6A H292045783406 H29204583091D H2920459310C5 H29204598AE16 H292046023930 H2920461003FA H2920461445DE H292046202992 H292046246FB6 H29204648F10A H292046524788 H2920465601AC H2920466408D6 H29204668C2BA H292046727438 H29204680D4E2 H29204682F7F0 H292046894923 H29204853461A H2920485432A5 H29204855232C H29204858F8C9 H2920486418CD H292048663BDF H292048672A56 H29204868D2A1 H29204869C328 H292048704731 H2920487156B8 H292048726423 H2920487375AA H292048740115 H29204875109C H292048762207 H29204883F662 H2920488482DD H29204891CCA8 H29204892FE33 H29204893EFBA H2920489940E0 H2920490050E5 H292049126A2F H292049206355 H292049224047 H292049242571 H292049260663 H2920492717EA H29204928EF1D H292049343CA9 H292049352D20 H292049361FBB H29204938F6C5 H292049456028 H29204947433A H29204948BBCD H29204949AA44 H29204958A215 H29204959B39C H2920496115BC H292049622727 H2920496336AE H292049644211 H292049655398 H292049666103 H29204967708A H29204968887D H2920496999F4 H292049818FAC H29204982BD37 H29204995D050 H29204996E2CB H29205003E2DB H29205012EA8A H29205025B45D H2920502686C6 H29205027974F H292050286FB8 H29205034BC0C H2920505822B0 H292050608490 H29205062A782 H292050691951 H292050832C1B H2920508458A4 H292050900758 H29205092244A H292050999A99 H292051019B15 H29205102A98E H29205105DD31 H29205107FE23 H29205115C4E9 H292051229A3E H29205124FF08 H29205133926F H29205134E6D0 H29205163ECD7 H29205166BB7A H2920518376C7 H292062040611 H292062051798 H29206207348A H29206208CC7D H29206209DDF4 H2920621059ED H292062114864 H292062127AFF H292062136B76 H292062141FC9 H292062150E40 H292062172D52 H29206218D5A5 H292062207385 H29206221620C H2920622435A1 H2920622616B3 H29206227073A H29206229EE44 H292062317BD4 H2920623358C6 H292062342C79 H292062353DF0 H292062371EE2 H29206238E615 H292062446171 H2920624570F8 H292062464263 H2920624753EA H292062503E8D H292062512F04 H292062521D9F H292062530C16 H29206
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
Philips Respironics, Inc.
Reason for Recall:
Firm has released a mandatory software update Version 1.05.10.00 and a User Manual addendum for affected ventilators. These updates resolve safety issues identified in earlier recalls.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
ongoing

Product Information

Full Description:

Trilogy Evo EV300 -- Model Number/ Model Description: BL2200X15B Trilogy Evo, O2, Benelux EV300; BR2200X18B Trilogy Evo, O2, Brazil EV300; CA2200X12B Trilogy Evo, O2, Canada EV300; DE2200X13B Trilogy Evo, O2, Germany EV300; DS2200X11B Trilogy Evo, O2, USA EV300; DS2200X11B Trilogy Evo, O2, USA EV300; EE2200X15B Trilogy Evo, O2, Eastern Europe EV300; ES2200X15B Trilogy Evo, O2, Spain EV300; EU2200X15B Trilogy Evo, O2, EU EV300; FR2200X14B Trilogy Evo, O2, France EV300; FX2200X15B Trilogy Evo, O2, INT EV300; GB2200X15B Trilogy Evo, O2, Great Britain EV300; IN2200X15B Trilogy Evo, O2, INTL EV300; IT2200X21B Trilogy Evo, O2, Italy EV300; KR2200X15B Trilogy Evo, O2, Korea EV300; ND2200X15B Trilogy Evo, O2, Nordics EV300; TR2200X15B Trilogy Evo, O2, Turkey EV300;

Product Codes/Lot Numbers:

Model / UDI-DI: Trilogy Evo, O2, Benelux EV300 606959058668; Trilogy Evo, O2, Brazil EV300 606959058583; Trilogy Evo, O2, Canada EV300 606959052321; Trilogy Evo, O2, Germany EV300 606959058651; Trilogy Evo, O2, USA EV300 606959052017; Trilogy Evo, O2, USA EV300 606959052017; Trilogy Evo, O2, Eastern Europe EV300 606959058705; Trilogy Evo, O2, Spain EV300 606959058644; Trilogy Evo, O2, EU EV300 606959058682; Trilogy Evo, O2, France EV300 606959058613; Trilogy Evo, O2, INT EV300 606959061033; Trilogy Evo, O2, Great Britain EV300 606959058675; Trilogy Evo, O2, INTL EV300 606959056497; Trilogy Evo, O2, Italy EV300 606959058637; Trilogy Evo, O2, Korea EV300 606959058590; Trilogy Evo, O2, Nordics EV300 606959058620; Trilogy Evo, O2, Turkey EV300 606959058798; US Serial Numbers: H284098132DDA H284098302CF1 H33497881D1CB H33497883F2D9 H33497890D99A H334979140BA2 H358294978811 H35830133F8DF H35830506E67B H35830557894A H358305795384 H35830750484D H29713003B682 H297748223EC0 H28409798170E H28409822163B H284098331E6A H28409838A0B9 H284098417070 H2840984427DD H337553143AE3 H337559067353 H337559303C0D H2968179381A6 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 H355158896233 H355159042DCA H355182800707 H35518305C4B6 H35518320A0AB H28174967D3FE H3551591340AD H355182967BE9 H35518299831E H355183081F53 H355183191702 H28174888EBC5 H29532491238C H29532493009E H338249101E53 H2953248208CF H295324857C70 H295324864EEB H295324875F62 H29532488A795 H29532489B61C H295324903205 H294580134E22 H294580775CD6 H29458084ED85 H2945808827E9 H294580983E31 H2945818785C2 H29458190E8A5 H294602075C72 H29460292DCC7 H294603336AE2 H294603350FD4 H294603363D4F H294603489939 H2946034988B0 H2946036026C1 H294603613748 H29460378B351 H29460385EB7C H29460396C03F H294603982941 H29460411F645 H294604186B84 H294604259A09 H2946043583D1 H29460436B14A H296103632CD0 H2983059175F9 H288916282C32 H2889206563A3 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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 H2903946357C4 H290394752B2A H2903947619B1 H290395603F83 H29039741A802 H29039780102B H29039816E8C2 H290398392385 H29039841E2C5 H29039845A4E1 H29039852C986 H29039853D80F H29039855BD39 H290398597755 H290398814B65 H29040791D1C5 H2904111482CA H290411159343 H29041116A1D8 H29041119592F H29041120EE86 H29041123DC1D H290411268BB0 H29041133C5C5 H29041134B17A H29041147CEE9 H2904120123DB H290422257382 H290422434264 H290423037FD8 H290423040B67 H29042309D082 H290423353086 H290423667CA5 H290423698452 H2904249762E1 H290425282462 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H292050286FB8 H29205034BC0C H2920505822B0 H292050608490 H29205062A782 H292050691951 H292050832C1B H2920508458A4 H292050900758 H29205092244A H292050999A99 H292051019B15 H29205102A98E H29205105DD31 H29205107FE23 H29205115C4E9 H292051229A3E H29205124FF08 H29205133926F H29205134E6D0 H29205163ECD7 H29205166BB7A H2920518376C7 H292062040611 H292062051798 H29206207348A H29206208CC7D H29206209DDF4 H2920621059ED H292062114864 H292062127AFF H292062136B76 H292062141FC9 H292062150E40 H292062172D52 H29206218D5A5 H292062207385 H29206221620C H2920622435A1 H2920622616B3 H29206227073A H29206229EE44 H292062317BD4 H2920623358C6 H292062342C79 H292062353DF0 H292062371EE2 H29206238E615 H292062446171 H2920624570F8 H292062464263 H2920624753EA H292062503E8D H292062512F04 H292062521D9F H292062530C16 H29206

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-2942-2024

Related Recalls

Certain serial numbers of the SimplyGo Mini standard battery kit contain a defective chip which can lead the battery to either fail to charge or lose voltage output when in use in the device. If the fault occurs while the device is running on battery power, the SimplyGo Mini will shut down and stop providing oxygen to the user. This may happen at a temperature within the specified operating temperature range of the SimplyGo Mini.

Oct 7, 2025 Other Medical Devices Nationwide View Details →