Trilogy Evo; Model No./Model Description -- AU2110X15B Trilogy Evo, Australia BL2110X15B Trilogy Evo, Benelux BR2110X18B Trilogy Evo, Brazil CA2110X12B Trilogy Evo, Canada DE2100X13B Trilogy Evo O2, Germany DE2110X13B Trilogy Evo, Germany DS2100X11B Trilogy Evo, O2, USA DS2110X11B Trilogy Evo, USA DS2110X11B Trilogy Evo, USA EE2100X15B Trilogy Evo O2, Eastern Europe EE2110X15B Trilogy Evo, Eastern Europe ES2100X15B Trilogy Evo O2, Iberia ES2110X15B Trilogy Evo, Iberia EU2100X15B Trilogy Evo, O2, EU EU2100X19 Trilogy Evo, O2, EU (Non-BT) EU2110X15B Trilogy Evo, EU EU2110X19 Trilogy Evo, EU (Non-BT) FR2100X14B Trilogy Evo O2, France FR2110X14B Trilogy Evo, France FX2100X15B Trilogy Evo, O2, INT GB2110X15B Trilogy Evo, Great Britain IA2100X15B Trilogy Evo O2, India IA2110X15B Trilogy Evo, India IN2100X15B Trilogy Evo, O2, International IN2100X19 Trilogy Evo, O2, International (Non-BT) IN2110X15B Trilogy Evo, International IT2100X21B Trilogy Evo O2, Italy IT2110X21B Trilogy Evo, Italy JP2100X16B Trilogy Evo, O2, Japan JP2110X16B Trilogy Evo, Japan KR2110X15B Trilogy Evo, Korea LA2100X15B Trilogy Evo, O2, Latin America LA2110X15B Trilogy Evo, Latin America LD2110X23B Garbin Evo, Linde ND2100X15B Trilogy Evo O2, Nordics ND2110X15B Trilogy Evo, Nordics RDS2110X11B Trilogy Evo, USA-Rental SP2100X26B LifeVentEVO2 TR2110X15B Trilogy Evo, Turkey UDS2110X11B Trilogy Evo, USA-RECERT VT2110X24B Aeris EVO

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 Description/ UDI-DI-- Trilogy Evo, Australia 606959051980; Trilogy Evo, Benelux 606959055520; Trilogy Evo, Brazil 606959055476; Trilogy Evo, Canada 606959052307; Trilogy Evo O2, Germany 606959054103; Trilogy Evo, Germany 606959054110; Trilogy Evo, O2, USA 606959051997; Trilogy Evo, USA 606959051942; Trilogy Evo, USA 606959051942; Trilogy Evo O2, Eastern Europe 606959055698; Trilogy Evo, Eastern Europe 606959055544; Trilogy Evo O2, Iberia 606959054097; Trilogy Evo, Iberia 606959054080; Trilogy Evo, O2, EU 606959055674; Trilogy Evo, O2, EU (Non-BT) 606959055681; Trilogy Evo, EU 606959054981; Trilogy Evo, EU (Non-BT) 606959055537; Trilogy Evo O2, France 606959055643; Trilogy Evo, France 606959055506; Trilogy Evo, O2, INT 606959061019; Trilogy Evo, Great Britain 606959054127; Trilogy Evo O2, India 606959055636; Trilogy Evo, India 606959055490; Trilogy Evo, O2, International 606959054059; Trilogy Evo, O2, International (Non-BT) 606959055575; Trilogy Evo, International 606959051959; Trilogy Evo O2, Italy 606959055438; Trilogy Evo, Italy 606959055421; Trilogy Evo, O2, Japan 606959055582; Trilogy Evo, Japan 606959051973; Trilogy Evo, Korea 606959055483; Trilogy Evo, O2, Latin America 606959055599; Trilogy Evo, Latin America 606959055452; Garbin Evo, Linde 606959057432; Trilogy Evo O2, Nordics 606959055650; Trilogy Evo, Nordics 606959055513; Trilogy Evo, USA-Rental 606959060517; LifeVentEVO2 606959057456; Trilogy Evo, Turkey 606959055551; Trilogy Evo, USA-RECERT 606959060500; Aeris EVO 606959062962; US Serial Nos. H25772938289E H31256551DA06 H2645481034BB H264549117FEE H293726775CF8 H293726839914 H29373939849A H3219367937EE H32194038C0FF H312413120541 H3125248270D5 H31252485046A H312586847CF5 H31260269A675 H3126027133E5 H3126145857F6 H31261473DA95 H312614853C6B H31261492510C H31261503CD41 H31261510E602 H31261553B3F9 H31261557F5DD H31261565FCA7 H3126168943BF H31261692E4B4 H31261693F53D H312616948182 H31261696A290 H31261697B319 H312617015BEB H312617051DCF H312617062F54 H312617073EDD H31261708C62A H31261709D7A3 H3126171053BA H3126171270A8 H312617136121 H35712170BF53 H35713165ED9D H35718858401B H357297078DE4 H35730100DDA5 H357301279AAA H35730132D4DF H35730164CF51 H3573020211D3 H357312415893 H35731259CD03 H357313262220 H357313498E07 H357313500A1E H35731352290C H35731452A509 H35731467D8CC H357315768A41 H35731743423C H357317443683 H357317461591 H357317535BE4 H357317626005 H35731768CF5F H3573177279DD H35731778D687 H35731779C70E H35731787ADB8 H357318005D00 H357318173067 H3573183520C5 H35731854659C H35731874562C H35731896EF2E H357319132C9F H36031701B2F1 H36031707D7C7 H360317093EB9 H360317281C80 H36031743F683 H36031744823C H3603174593B5 H36031751CC49 H360317549BE4 H360317824EAA H36088293C1C9 H36088294B576 H360900410987 H36101867D037 H36101875EAFD H361018792091 H361018803E98 H361018821D8A H361018830C03 H361018874A27 H3610189753FF H36101899BA81 H36101900AA84 H361019028996 H36101903981F H36101904ECA0 H36101905FD29 H3610190826CC H361019093745 H36101911A2D5 H3610191381C7 H361099004F5C H361099015ED5 H361099037DC7 H36109937118B H36109940283C H3610994139B5 H361099464D0A H361099556649 H361099676F33 H361099744470 H3610997555F9 H361099766762 H3610997776EB H361099788E1C H361099799F95 H36109980819C H361099819015 H36109983B307 H36109984C7B8 H36109985D631 H36109986E4AA H36109987F523 H361099909844 H3610999189CD H36109992BB56 H36109993AADF H36109995CFE9 H36127266EFD6 H361273759E49 H363518889CD2 H36358463E4D1 H363596437E62 H363599125B94 H3636016234F1 H363602768469 H363603874CF4 H36360439CD27 H363604410C67 H363604631CC5 H36360494EBB2 H363605289FAA H36360616B3D8 H363606439ACD H36360666FED0 H36360704D3CE H36360726C36C H3636077854AA H36360802FC3F H36360867FF42 H363608977C8A H36360903B76A H36360915CB84 H36360931BE10 H36360947962E H363609497F50 H363619827498 H364081649356 H364081862A54 H364088166152 H36031627BEAB H36031666C842 H360317192761 H36031740C418 H36031761E621 H360317779ACF H3603177973B1 H36034756D6A1 H360350809351 H3603510116C4 H3603511892DD H360351313C

Risk classification

Class I

Area (FDA)

device

Country

United States