Philips Respironics, Inc. recalls BiPAP A40 Ventilator. Used to provide noninvasive ventilation support for the purpose o…
Reason for recall
This device does not indicate for use in patients with respiratory failure.
Affected product
Check your device
Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.
BiPAP A40 Ventilator. Used to provide noninvasive ventilation support for the purpose of treating adult and pediatric patients. BiPAP A40 Pro - sold OUS
Lot / code information
- UDI
- 00606959039476
- Serial #
- V182393118CC9 V21942863DD70 V219429359C22 V25585948745C V26439189762A V2640770372E7 OUS: A40: Material No. 1111169
- UDI
- 00606959039476
- Serial #
V09765327781A V09765332366F V097653405875 V097653436AEE V097653472CCA V0976535041AD V097653551600 V09765356249B V09765358CDE5 V100863961519 V10086398FC67 V10086399EDEE V100864020820 V10086408A77A V100…Show all
V09765327781A V09765332366F V097653405875 V097653436AEE V097653472CCA V0976535041AD V097653551600 V09765356249B V09765358CDE5 V100863961519 V10086398FC67 V10086399EDEE V100864020820 V10086408A77A V1008641032EA V100864112363 V100864130071 V1008641474CE V100864201882 V100864223B90 V100864276C3D V10086436646C V100864388D12 V100864399C9B V100864426F40 V100864437EC9 V100864462964 V10086448C01A V10086450558A V100864514403 V100864527698 V100864536711 V100864550227 V1008645630BC V10086459C84B V100864616E6B V100864634D79 V1008646439C6 V10086465284F V100864670B5D V10086468F3AA V1008643333C1 V1008647177B3 V100864724528 V100864771285 V10086478EA72 V10086479FBFB V1008648869BA V100864013ABB V100864267DB4 V100864451BFF V10086458D9C2 V100864625CF0 V100864753197 V10086484A3D6 V10086476030C V10086509EC2F V100865489AC6 V10086482C6E0 V1008643556F7 V100865124B24 V100865262768 V10086528CE16 V100865454123 V100864002B32 V100864415DDB V10086469E223 V1008650437CA V1008652370C5 V1008640319A9 V10086485B25F V10271624DE95 V10271625CF1C V10271627EC0E V1027162814F9 V102716290570 V102716308169 V1027163190E0 V10271633B3F2 V10271664B9F5 V102716943A3D V102716952BB4 V10271696192F V10271698F051 V10271699E1D8 V10271700F1DD V10271704B7F9 V1027170694EB V10271711F98C V10271712CB17 V10271713DA9E V10271714AE21 V10271726A75B V10271727B6D2 V10307238112D V103072449649 V10307246B55B V10307252EAA7 V103072548F91 V10307256AC83 V10307257BD0A V103072595474 V10307260E3DD V10307261F254 V10307262C0CF V10307265B470 V103072679762 V103072697E1C V10307271EB8C V10307274BC21 V10086542359C V10307250C9B5 V10307251D83C V1030726686EB V10307410780C V103074134A97 V103074161D3A V103074304BBC V1030742143ED V10390418F201 V102716082749 V102716183E91 V103072485C25 V10307272D917 V10307273C89E V103074116985 V10307438C7F4 V104077648095 V10407766A387 V10407767B20E V10407774994D V1040777588C4 V10407776BA5F V104077814D28 V104077827FB3 V10407831E347 V1030799049B3 V10307991583A V103079926AA1 V103079951E1E V10308004F668 V1039042366BA V104077850B0C V10407787281E V10407789C160 V104077904579 V10407792666B V1040779377E2 V1040779731C6 V10407798C931 V10407799D8B8 V10407800D8A6 V10407802FBB4 V10407806BD90 V10407811D0F7 V10407813F3E5 V1040781596D3 V104078184D36 V10407820EB16 V10407823D98D V104077695B70 V10407832D1DC V100864075F8D V10086409B6F3 V103080083C04 V10308017DD2B V10407828675E V10298868FB59 V10298869EAD0 V102988706EC9 V102988724DDB V102988735C52 V102988753964 V102988760BFF V102988771A76 V10298880ED01 V10298881FC88 V10298882CE13 V10298929D76C V107026380CB7 V107026391D3E V10702641DC7E V102988868837 V10702632A3ED V10878228A7F5 V108782303265 V1087823123EC V1087823565C8 V1087823746DA V1029891243D7 V108946784CA0 V109044236C3C V109044241883 V109044263B91 V109044272A18 V10904430477F V1090443156F6 V10904432646D V10904434015B V1090443510D2 V109044362249 V109044400A77 V109044411BFE V1090444338EC V109044444C53 V109044455DDA V109044466F41 V109044532134 V10904428D2EF V1090443375E4 V109045617292 V109045635180 V10904564253F V10904566062D V10904568EF53 V10904569FEDA V109045707AC3 V1090457259D1 V109045743CE7 V10904579E702 V10904580F90B V10904581E882 V10904585AEA6 V109045869C3D V1090458964CA V10904590E0D3 V10904595B77E V109045986C9B V10904600D8AF V10904601C926 V10904603EA34 V10904613F3EC V109046148753 V1090461596DA V10904617B5C8 V10904620EB1F V109046286757 V10904630F2C7 V10904633C05C V109046387E8F V109046429CDD V110222430981 V110222474FA5 V11022248B752 V1102225022C2 V108788983027 V1087902082BE V110452660125 V1104527618FD V110452770974 V11045282DD11 V11045285A9AE V10878904778F V108789102873 V1087891139FA V109045716B4A V10904609456E V110222361324 V11022249A6DB V1102281036D8 V110452743BEF V11045268E85B V110452707DCB V11070492618B V110704973626 V11022681E052 V1107049627AF V11081792F8A8 V11081796BE8C V11081797AF05 V11081799467B V1108180157EC V11081809DBA4 V110818127CAF V110818163A8B V1108182075D5 V1108182610E3 V11081828F99D V110818317D84 V110818335E96 V1108183718B2 V11081838E045 V11081841308C V110818420217 V110818446721 V1108184576A8 V11081848AD4D V1108185038DD V110818530A46 V110818547EF9 V110818521BCF V110818667783 V11081867660A V110818700B6D V110818755CC0 V110818766E5B V110818777FD2 V1108188088A5 V11081881992C V11081884CE81 V11081885DF08 V11081887FC1A V1108188804ED V110818891564 V11081893A3E6 V1122522030BD V112252357EC8 V112252364C53 V112252375DDA V11225238A52D V11225239B4A4 V1122524356F6 V11225249F9AC V112252543B91 V11225258F1FD V11225259E074 V11081997BF1E V1108200397F1 V11082005F2C7 V11082007D1D5 V11082010BCB2 V11082014FA96 V11082015EB1F V110820192173 V109046058F02 V1108182433F1 V11082016D984 V112252212134 V1102270600F1 V110818136D26 V1102223702AD V110818252278 V109045398062 V1090454050AB V109045414122 V1090454273B9 V109045436230 V10904544168F V10904546359D V109045472414 V10904548DCE3 V10904549CD6A V109045504973 V1108179857F2 V110818040041 V11081819C27C V1108182256C7 V110818342A29 V110818464433 V110818565DEB V110818574C62 V11081859A51C V110818654518 V1108189180F4 V1122520777B2 V112252101AD5 V11225240646D V10878895EBC2 V1029891426E1 V10879036FE50 V10904612E265 V10904641AE46 V110817958C17 V1122526057DD V11249656D74E V11249665CFBD V11383609FEB4 V113836107AAD V113836116B24 V113836143C89 V113836161F9B V113836170E12 V11383618F6E5 V11383619E76C V1138362050C5 V11383623625E V113836250768 V113836337B86 V113836340F39 V113836351EB0 V113836444231 V113836466123 V1138364770AA V11383648885D V113836501DCD V113836510C44 V113836545BE9 V113836554A60 V1138365678FB V113836576972 V11383659800C V113836665293 V11383668BBED V1138367579D0 V11383681BC3C V113836839F2E V11383684EB91 V11383697C0D2 V113836983825 V113837012820 V1138371131F8 V11383719BDB0 V113837389F89 V113837405EC9 V113837414F40 V113837427DDB V113837436C52 V11489234AC27 V1148923977C2 V11489240A70B V11489241B682 V114892439590 V11489244E12F V11489245F0A6 V114892482B43 V112401182C36 V11240125DDBB V11240126EF20 V11240127FEA9 V11240135C463 V11240136F6F8 V11240145896B V112401494307 V11240151D697 V11240152E40C V11240153F585 V11240154813A V11240156A228 V1124015 …
Additional code information
8 V147324598EEC V147324603945 V147324621A57 V14732469A484 V14732472038F V14732480A355 V14732481B2DC V147324828047 V1473248391CE V14732490BA8D V14732491AB04 V14732494FCA9 V147325003749 V14732502145B V14732504716D V1473250560E4 V14732506527F V1473250743F6 V14732508BB01 V147325131C0A V14732515793C V147325164BA7 V147325175A2E V14732518A2D9 V14732519B350 V1473252004F9 V147325211570 V1473252442DD V147325255354 V1473252661CF V147325277046 V147325299938 V147325301D21 V147325310CA8 V147325323E33 V147325332FBA V147325345B05 V147325354A8C V147325367817 V14732537699E V147325389169 V1473253980E0 V147325405029 V1473254141A0 V14732542733B V1473254362B2 V14732544160D V147325450784 V14732546351F V14732548DC61 V14732549CDE8 V1473255049F1 V147325515878 V147325526AE3 V147325540FD5 V147325551E5C V147325562CC7 V147325573D4E V147325606399 V147325617210 V147325671726 V14732568EFD1 V14732569FE58 V147325716BC8 V147325725953 V1473257348DA V147325743C65 V147325752DEC V147325761F77 V147325770EFE V14732579E780 V14732580F989 V14732581E800 V14732582DA9B V14732583CB12 V14732584BFAD V14732585AE24 V147325869CBF V147325878D36 V1473258875C1 V147325896448 V14732590E051 V14732591F1D8 V14732592C343 V14732593D2CA V14732594A675 V147325968567 V147325986C19 V147403068D0C V14740310F1E2 V14740347FBE5 V1474037938F3 V14740389BB3B V147403921C30 V147325472496 V14732562408B V1473256425BD V147402935765 V14740299F83F V147403196C23 V14740400643F V145396303A06 V147324263B13 V1473246128CC V14732558C5B9 V14732559D430 V147324205E25 V14732429C3E4 V147324400AF5 V147324411B7C V147324477E4A V1473256606AF V14732595B7FC V147325653434 V14842251D928 V14842252EBB3 V14842253FA3A V148422548E85 V148422559F0C V14842256AD97 V14842257BC1E V148422595560 V14842260E2C9 V14842261F340 V14842262C1DB V14842263D052 V14842264A4ED V14842265B564 V1484226687FF V148422679676 V148422686E81 V14842270FB11 V14842271EA98 V14842272D803 V14842273C98A V1484228078D9 V148422816950 V148422834A42 V148422843EFD V148422852F74 V148422861DEF V14842289E518 V148422917088 V1484229536AC V148422960437 V1484229715BE V14842298ED49 V14842301FD4C V14842302CFD7 V14842303DE5E V14842304AAE1 V14842305BB68 V1484230689F3 V14842307987A V148423097104 V14842310F51D V14842311E494 V14842312D60F V14842314B339 V14842316902B V1484231781A2 V1484231968DC V14842321CEFC V14853204E7C2 V14853206C4D0 V14853207D559 V14853210B83E V148532138AA5 V14853215EF93 V148532209256 V1485322183DF V14853226F760 V14853227E6E9 V148532290F97 V148532319A07 V14853232A89C V14853239164F V14853241D70F V1485324480A2 V14853245912B V14853247B239 V14853254997A V14853256BA68 V14853259429F V14853263C7AD V148532669000 V148532678189 V1485326968F7 V14853270ECEE V14853271FD67 V14853274AACA V148532779851 V14853279712F V148532806F26 V148532824C34 V148532835DBD V148532484ACE V14853265A29B V14853268797E V14853223A0CD V14853260F536 V148532183476 V14853237FF31 V14853243F41D V148532495B47 V1484227966D0 V14847428B16F V14847429A0E6 V148474375040 V14847438A8B7 V14847439B93E V148474460CC1 V148474552782 V148474570490 V14847458FC67 V148474650DEA V148474672EF8 V14847470439F V148474773720 V14847486A561 V14847487B4E8 V148474884C1F V148474949FAB V148474958E22 V14847496BCB9 V1484749855C7 V14847499444E V14847509C98A V1484751628A5 V14847517392C V14847518C1DB V14847519D052 V1484752067FB V148475217672 V148475253056 V14847528EBB3 V148475307E23 V148475361B15 V14847539E3E2 V14847540332B V1484754122A2 V1484754301B0 V14847549AEEA V148475513B7A V148475564FC5 V148475575E4C V14847559B732 V148475633200 V14943206CBBF V14943207DA36 V1494320822C1 V149432093348 V14943216D267 V149432192A90 V149432209D39 V149432218CB0 V149432281171 V1494323084E1 V149432319568 V14943233B67A V14943234C2C5 V14943235D34C V14943236E1D7 V14943237F05E V1494323808A9 V149432459E44 V14943246ACDF V14943247BD56 V149432495428 V14943256B507 V14943260FA59 V14943273D11A V1494328171C0 V1494328537E4 V14847478CFD7 V14847558A6BB V1494328714F6 V148534765F01 V14853478B67F V14853479A7F6 V148534838B64 V14853484FFDB V14853486DCC9 V14853490A027 V14853491B1AE V14853508A1AB V14853530078B V148535399A4A V148535426991 V148535437818 V148535717162 V148535735270 V148535276AEC V14853559CE9A V148535670D8C V150107064B3D V150107075AB4 V15010708A243 V1501071214C1 V15010715607E V15010718BB9B V150107210C32 V150107223EA9 V15010729807A V1501073999A2 V15016554E8B5 V15016555F93C V15016562A7EB V15016564C2DD V15016565D354 V15016566E1CF V1501656808B1 V15016572BE33 V15016574DB05 V150165781169 V150165810F60 V150165823DFB V150165867BDF V150165966207 V150166003F4D V150166047969 V1501660568E0 V150166065A7B V150166102695 V15016611371C V1501661460B1 V150166157138 V150166255B50 V1501075050B3 V150107536228 V150107616B52 V1501076259C9 V150107643CFF V150107652D76 V150107661FED V150107670E64 V15010768F693 V15010769E71A V15010771728A V150107724011 V150107735198 V150107742527 V150107760635 V15010778EF4B V151102076722 V151102111BCC V151102144C61 V151102166F73 V15110218860D V151102199784 V1511022131A4 V1511022312B6 V151102257780 V15110226451B V151102275492 V15110229BDEC V15110231287C V151102347FD1 V15110238B5BD V15110239A434 V151102434666 V15110249E93C V151102535FBE V151102553A88 V15110258E16D V15110262645F V151102714F1C V15016613140E V150166200CFD V152392931588 V152392946137 V15239300AAD7 V1523930289C5 V15239326FC51 V15239328152F V15239332A3AD V15239334C69B V15239335D712 V15239336E589 V15239306CFE1 V15239308269F V15239311A286 V15239312901D V15239314F52B V15239316D639 V15239317C7B0 V152393183F47 V152393209967 V15239342EEA5 V152393495076 V15229504316E V1522950520E7 V15229506127C V15229509EA8B V1523933080BF V152295106E92 V152295124D80 V152295135C09 V15229515393F V152295160BA4 V152295171A2D V15229518E2DA V15229519F353 V1522952044FA V152295237661 V1522952402DE V1535426675D1 V153542689CAF V153542698D26 V15354270093F V1535427118B6 V153542733BA4 V153542744F1B V153542755E92 V153542766C09 V153542788577 V15229508FB02 V153542777D80 V1535427994FE V153542808AF7 V153542819B7E V15354282A9E5 V15354283B86C V15354284CCD3 V15354285DD5A V1522950703F5 V153842056FEE V153842065D75 V153842074CFC V15384208B40B V15384209A582 V153842131300 V1538421467BF V1538421644AD V153842175524 V15384218ADD3 V15384219BC5A V1538422228E1 V153842233968 V153842244DD7 V153842255C5E V153842266EC5 V153842277F4C V1538422887BB V15384230122B V153842323139 V15384236771D V153842376694 V153842389E63 V153842414EAA V153842427C31 V153842441907 V153842436DB8 V15384245088E V153842463A15 V153842472B9C V15384249C2E2 V153542722A2D V153842157636 V153842398FEA V1526725225B7 V152672675872 V15267273078E V152672838446 V15267297DBBA V1538425046FB V1538425265E9 V153842537460 V153842573244 V15384258CAB3 V153842606C93 V153842617D1A V153842624F81 V15384267182C V15384268E0DB V15384269F152 V15384270754B V153842725659 V1538427347D0 V15384274336F V1538427522E6 V15384276107D V1538427701F4 V15384279E88A V15384280F683 V15384282D591 V15384284B0A7 V1538428693B5 V15384287823C V15384292CC49 V153842979BE4 V153842986313 V15384300629F V15384302418D V1538430424BB V153843071620 V15384308EED7 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What the firm is doing
Philips sent an "URGENT Medical Device Recall Notice", for All BiPAP A30 and BiPAP A40 devices, to consignees via mail 5/9/2025. Note, the letter does not address BiPAP V30 devices. The Notice informs consignees that for patients who cannot tolerate interruption or loss of therapy an alternative ventilator is required. Philips Respironics recommends that physicians and healthcare professionals assess whether the patients under their care who are using affected devices are able to tolerate interruptions to therapy. For patients who can and cannot tolerate interruptions in therapy, Philips Respironics provides recommendations for the clinicians and patients to consider. Patients who cannot tolerate interruptions in therapy are directed to contact their physician to expedite transition to an alternative ventilator. If a Ventilator Inoperative alarm occurs and an alternative is not available, follow Appendix A3 on how to perform a hard reboot. Consignees with any questions are to call 1-800-345-6443, prompts 4/5 or email respironics.clinical@philips.com. An additional communication was sent to consignees on 9/12/25 with further guidance for users.
DistributionShow detailsHide
Worldwide distribution: US (Nationwide)including Guam and Puerto Rico; OUS (Foreign) to countries of: United Arab Emirates (AE), Argentina (AR), Austria (AT), Australia (AU), Bosnia and Herzegovina (BA), Belgium (BE), Brazil (BR), Canada (CA), Chile (CL), China (CN), Colombia (CO), Costa Rica (CR), Germany (DE), Denmark (DK), Spain (ES), France (FR), United Kingdom (GB), Hong Kong (HK), Hungary (HU), Indonesia (ID), Ireland (IE), India (IN), Italy (IT), Jordan (JO), Japan (JP), Korea, Republic of (KR), Lebanon (LB), Morocco (MA), Monaco (MC), Montenegro (ME), Mexico (MX), Malaysia (MY), Netherlands (NL), Norway (NO), Nepal (NP), Peru (PE), Philippines (PH), Pakistan (PK), Poland (PL), Portugal (PT), Qatar (QA), Romania (RO), Serbia (RS), Russian Federation (RU), Saudia Arabia (SA), Singapore (SG), Slovakia (SK), Thailand (TH), Turkey (TR), Taiwan (TW), Viet Nam (VN), South Africa (ZA).
A reasonable probability that use of the product will cause serious adverse health consequences or death.
Sources & references
- FDA enforcement recordOfficial FDA database entry for Z-2037-2025
- FDA 510(k) clearance · K121623The device's official FDA premarket clearance record
- FDA device classification · MNTOfficial FDA classification for this device type
- CFR regulation · 21 CFR 868.5895The federal regulation governing this device
- FDA recall announcementSearch FDA.gov for the official press announcement
- Find Philips Respironics, Inc.Search for the manufacturer's official notice
- News coverageRecent reporting on this recall and manufacturer
- openFDA data recordThe raw JSON record this page is built from
Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.
Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.
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