FDAFDA · Food and drugs·Recall number Z-2942-2024
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;
Published September 11, 2024 · Recall initiated: July 16, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Philips Respironics, Inc.
- Distributor
- Worldwide distribution: US (nationwide) and OUS (foreign) countries of: AU, BD, BE, BG, BO, BR, BS, CH, CL, NL, CN, CO, CZ, DE, DK, FR, SE, GB, GF, GR, GT, HK, HR, HU, IE, IL, IN, IT, JP, KE, KW, LB, LT, MA, ME, MA, MT, MQ, MX, NO, NP, OM, PA, PE, PF, PK, PL, PT, PY, QA, RE, RO, RS, RU, SA, SE, SI, SK, SG, TH, TN, TR, TW, UA, YT, ZA and ZW.
- Lot
- 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 H358298468C43 H3582988
- Risk classification
- Class I
- Area (FDA)
- device
- Country
- United States
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