Skip to content
Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 90695

6 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
August 26, 2022
Product types
Device
Classifications
Class I
Statuses
Ongoing
Recalling firm wording
Philips Respironics, Inc.

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

6 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 6

Philips BiPAP A30, Rx Only. To provide noninvasive ventilation support for patients with obstructive sleep apnea syndrome (OSA) and respiratory insufficiency.

Z-1654-2022
Recall number
Z-1654-2022
Initiated
August 26, 2022
Classification
Class I
Status
Ongoing
Recalling firm
Philips Respironics, Inc.
Quantity
146 units ***updated January 2024*** 30 additional units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Motor assemblies manufactured with nonconforming plastic that contributes to off-gassing of VOCs.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Motor assemblies manufactured with nonconforming plastic that contributes to off-gassing of VOCs.

Code information

UDI-DI:606959042667, 606959042681, 606959042698, 606959042728, 606959067585, 606959067530; Model No.: 1109581, 1109582, 1109585, 1109588, 1109589, 1109590, 1109594, 1109596, 1109598, 1109601, 1111124, 1111150, 1111155, 1111169, 1111177, 1111178, 1116153, 1116156, CN1111143, CN1111169, R1111124, R1111177; Serial No.: N287725308B25, N28870219ADAE, N288702267F31, N2887023003DF, N288702473A68, N28870248C29F, N2887025723B0, N28870279F97E, N28870300736B, N2887030162E2, N2887030341F0, N288703153D1E, N288703341F27, N28870339C4C2, N288703423719, N2887034989CA, N288703533F48, N288710382694, N28871040E7D4, N28871042C4C6, N28871043D54F, N28871045B079, N28871047936B, N288710486B9C, N28872243453A, N28872424B38C, N28872434AA54, N30471136FB91, N304711485FE7, N30471153F8EC, N30471195347A, N30471199FE16, N3047120278B9, N304754069AA8, N30475435825B, N304754394837, N30475443AA65, N30475445CF53, N3047544814B6, N306144680873, N30614484580F, N306146006553, N3061460174DA, N306146024641, N3061460357C8, N3061460532FE, N3061461619BD, N30614661200A, N3061467139D2, N3061469380D0, N3061471314CC, N3061473453C3, N306147376158, N30614793DA0C, N30614795BF3A, N306148142AB4, N306148336DBB, N30614918BA04, N306149333767, N30614983D3CF, N306150028C23, N306150218D08, N288885978931, N28888599604F, N28888601D47B, N28888602E6E0, N28888605925F, N28888606A0C4, N288886095833, N28888611CDA3, N28888613EEB1, N28888617A895, N290848821182, N2908488657A6, N29084889AF51, N290848964E7E, N290848975FF7, N29084900A68C, N29118378D6CD, N29118379C744, N29118381C8C4, N29118382FA5F, N29118383EBD6, N291183849F69, N291183858EE0, N291183885505, N29118390C095, N29118391D11C, N29118392E387, N29118393F20E, N2911839486B1, N291183959738, N29118380D94D, N29118387ADF2, N29118396A5A3, N2874293301D1, N287429470AFD, N28742976311C, N290952904FCD, N290952915E44, N290952926CDF, N290952937D56, N2909529409E9, N290952951860, N290952962AFB, N290952973B72, N29095298C385, N29095299D20C, N29095300C209, N29095301D380, N29095302E11B, N29095303F092, N2909530595A4, N29095306A73F, N29095307B6B6, N290953084E41, N290953095FC8, N29095310DBD1, N29095311CA58, N29095312F8C3, N29095313E94A, N290953149DF5, N290953158C7C, N29095316BEE7, N290953185799, N290953194610, N29095320F1B9, N29095321E030, N29095322D2AB, N29095323C322, N29095324B79D, N29095325A614, N29095326948F, N290953278506, N290953287DF1, N290953296C78, N29095330E861, N29095331F9E8, N29095332CB73, N29095333DAFA, N29095334AE45, N29095335BFCC, N290953368D57, N290953379CDE, N290953386429, N2909533975A0; ***updated Jan 2024***N30471136FB91, N304711485FE7, N30471153F8EC, N30471195347A, N30471199FE16, N3047120278B9, N304754069AA8, N30475435825B, N304754394837, N30475443AA65, N30475445CF53, N3047544814B6, N306144680873, N30614484580F, N306146006553, N3061460174DA, N306146024641, N3061460357C8, N3061460532FE, N3061461619BD, N3061467139D2, N3061469380D0, N3061471314CC, N3061473453C3, N30614795BF3A, N306148142AB4, N306149333767, N30614983D3CF, N306150028C23, N306150218D08;

Distribution pattern

Domestic: AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, ME, MI, MN, MO, MS, MT, NC, ND, NH, NJ, NV, NY, OH, OK, OR, PA, TN, TX, VA, VT, WA, WI, WV, & WY. Foreign: Australia, Austria, Bangladesh, Brazil, Canada, China, Denmark, Egypt, France, Germany, Hong Kong, Hungary, India, Israel, Italy, Japan, Malaysia, Mexico, Myanmar, Philippines, Qatar, Serbia, Singapore, Taiwan, Thailand, Turkey, UAE, & UK.

device · product 2 of 6

Philips BiPAP A40, Rx Only. To provide noninvasive ventilation support for patients with obstructive sleep apnea syndrome (OSA) and respiratory insufficiency.

Z-1655-2022
Recall number
Z-1655-2022
Initiated
August 26, 2022
Classification
Class I
Status
Ongoing
Recalling firm
Philips Respironics, Inc.
Quantity
1,091 units ***updated Jan 2024*** additional 323 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Motor assemblies manufactured with nonconforming plastic that contributes to off-gassing of VOCs.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Motor assemblies manufactured with nonconforming plastic that contributes to off-gassing of VOCs.

Code information

UDI-DI: 606959042742, 606959042766, 606959042797, 606959067677, 606959067714, 606959042834, 606959067752, 606959067721, 606959068025; Model No.: 1109596, 1109598, 1109601, 1111169, 1111177, 1116153, 1116156, CN1111169, R1111177; Serial No.: V287427181CF7, V28772370BAC2, V28772449816E, V2877247036C7, V287782070507, V288703803DF5, V288703847BD1, V288703856A58, V2887038658C3, V28870387494A, V28870388B1BD, V28870389A034, V28870390242D, V2887039135A4, V28870392073F, V288703946209, V288703957380, V28870396411B, V288703975092, V28870398A865, V28870399B9EC, V288704007F30, V288704016EB9, V288704025C22, V288704043914, V28870405289D, V288704061A06, V288704070B8F, V28870408F378, V28870409E2F1, V2887041066E8, V288704117761, V2887041245FA, V288704135473, V288704171257, V28870418EAA0, V28870419FB29, V288704215D09, V288704226F92, V2887246677A0, V288724698F57, V28872472285C, V288724777FF1, V28872479968F, V288724808886, V28872485DF2B, V28872492B24C, V28872495C6F3, V288724981D16, V288725001C9A, V288725010D13, V288725023F88, V288725032E01, V288725045ABE, V288725054B37, V288725100542, V2887251114CB, V288725122650, V2887251771FD, V28872518890A, V288725199883, V288725257887, V288725275B95, V28872528A362, V28872529B2EB, V2887253036F2, V28872531277B, V2887253215E0, V288725330469, V2887253470D6, V28872535615F, V2887253653C4, V28872537424D, V28872538BABA, V28872539AB33, V288725407BFA, V288725416A73, V2887254258E8, V288725434961, V288725452C57, V288725461ECC, V288725470F45, V28872548F7B2, V28872549E63B, V288725506222, V2887255173AB, V288725524130, V2887255350B9, V288725542406, V28872555358F, V288725560714, V28872557169D, V28872558EE6A, V28872559FFE3, V28872560484A, V2887256159C3, V288725626B58, V288725637AD1, V288725640E6E, V288725651FE7, V288725662D7C, V288725673CF5, V28872568C402, V28872569D58B, V288725705192, V28872571401B, V288725727280, V288725736309, V2887257417B6, V28872575063F, V2887257634A4, V28872577252D, V28872578DDDA, V28872579CC53, V28872580D25A, V28872581C3D3, V28872582F148, V28872583E0C1, V28872584947E, V2887258585F7, V28872586B76C, V28872590CB82, V28872591DA0B, V28872592E890, V28872593F919, V288725948DA6, V288725959C2F, V28872597BF3D, V2887259847CA, V288725995643, V28872601E277, V28872602D0EC, V28872605A453, V2887260696C8, V288726078741, V288726096E3F, V28872611FBAF, V28872612C934, V28872613D8BD, V28872614AC02, V28872615BD8B, V288726168F10, V288726179E99, V28872618666E, V28872620C04E, V28872621D1C7, V28872622E35C, V28872623F2D5, V28872624866A, V2887262597E3, V28872626A578, V28872627B4F1, V288726284C06, V288726295D8F, V28872630D996, V28872631C81F, V28872632FA84, V28872633EB0D, V288726358E3B, V28872636BCA0, V28872637AD29, V288726394457, V28872644D2BA, V2887278067E2, V288728509D5D, V28872870AEED, V28872877DA52, V288728802D25, V28872889B0E4, V2887289034FD, V288728930666, V28872900B939, V288729208A89, V28874377B86E, V288743784099, V288743795110, V28874797411F, V28874798B9E8, V28874799A861, V28874800A87F, V28874801B9F6, V288748028B6D, V288748039AE4, V28874804EE5B, V28874805FFD2, V28874806CD49, V28874807DCC0, V288748082437, V2887480935BE, V28874810B1A7, V28874811A02E, V2887481292B5, V28874813833C, V28874814F783, V28874815E60A, V28874816D491, V28874817C518, V288748183DEF, V288748192C66, V288748209BCF, V288748218A46, V28874823A954, V28874824DDEB, V28874825CC62, V28874826FEF9, V28874827EF70, V288748281787, V28874829060E, V288748308217, V28874831939E, V28874832A105, V28874833B08C, V28874834C433, V28874835D5BA, V28874836E721, V28874837F6A8, V288748380E5F, V288748391FD6, V28874840CF1F, V28874841DE96, V28874842EC0D, V28874843FD84, V28874844893B, V2887484598B2, V28874846AA29, V28874847BBA0, V288748484357, V2887484952DE, V28874851C74E, V28874853E45C, V2887485490E3, V28874855816A, V28874856B3F1, V288748594B06, V28874860FCAF, V28874861ED26, V28874864BA8B, V28874865AB02, V288748669999, V28888376542F, V2888837745A6, V28888378BD51, V28888385E57C, V28888387C66E, V288883892F10, V28888395FCA4, V28888396CE3F, V28888401E19D, V288884069522, V288884087C5C, V288884096DD5, V28888410E9CC, V28888412CADE, V28888413DB57, V28888415BE61, V288884168CFA, V288884179D73, V288884186584, V28888420C3A4, V28888421D22D, V28888422E0B6, V28888423F13F, V288884248580, V288884259409, V28888426A692, V28888427B71B, V288884284FEC, V288884349C58, V28888436BF4A, V28888437AEC3, V288884385634, V2888843947BD, V288884409774, V28888442B466, V28888444D150, V288884490AB5, V28888452ADBE, V28888457FA13, V2888845802E4, V28888461B54D, V28888468288C, V28888470BD1C, V288884729E0E, V288884738F87, V28888474FB38, V28888476D82A, V28888477C9A3, V2888847920DD, V288884821DC6, V288884830C4F, V288884856979, V288884865BE2, V28888488B29C, V28888489A315, V28888490270C, V288884913685, V28888492041E, V288884931597, V288884946128, V2888849570A1, V28888499BACD, V28888501BB41, V2888850289DA, V28888505FD65, V28888506CFFE, V288885093709, V28888510B310, V28888513818B, V288885183F58, V288885209978, V2888852188F1, V28888522BA6A, V28888523ABE3, V28888524DF5C, V28888525CED5, V28888526FC4E, V28888527EDC7, V288885281530, V2888852904B9, V2888853080A0, V28888532A3B2, V28888533B23B, V28888535D70D, V28888536E596, V28888537F41F, V288885380CE8, V28888541DC21, V28888542EEBA, V28888543FF33, V288885448B8C, V288885459A05, V28888546A89E, V290847074276, V29084708BA81, V29084709AB08, V290847102F11, V290847113E98, V290847120C03, V290847131D8A, V290847146935, V2908471578BC, V290847164A27, V290847175BAE, V29084718A359, V29084719B2D0, V290847200579, V2908472114F0, V29084722266B, V2908472337E2, V29084724435D, V2908472552D4, V29084726604F, V2908472771C6, V290847288931, V2908472998B8, V290847301CA1, V290847310D28, V290847323FB3, V290847332E3A, V290847345A85, V290847354B0C, V290847367997, V29084737681E, V2908473890E9, V290847398160, V2908474051A9, V290847414020, V2908474272BB, V290847436332, V29084744178D, V290847450604, V29084746349F, V290847472516, V29084748DDE1, V29084749CC68, V290847504871, V2908475159F8, V290847526B63, V290847537AEA, V290847540E55, V290847551FDC, V290847562D47, V291183973474, V29118398CC83, V29118399DD0A, V291184010A5F, V2911840238C4, V291184054C7B, V291184067EE0, V291184076F69, V29118408979E, V29118410020E, V291184111387, V29118412211C, V291184133095, V29118414442A, V2911841555A3, V291184166738, V2911841776B1, V291184202866, V2911842139EF, V291184220B74, V291184246E42, V291184257FCB, V291184275CD9, V29118428A42E, V2911843031BE, V291184312037, V2911843212AC, V29118434779A, V291184356613, V291184365488, V29118438BDF6, V29118439AC7F, V291184416D3F, V291184434E2D, V291184443A92, V29118450656E, V2911845532C3, V29118458E926, V29118468C34E, V2911847056DE, V291184772261, V291184849332, V29118487A1A9, V29118490CCCE, V291184948AEA, V291185037391, V29118506243C, V2911850735B5, V29118509DCCB, V291185216333, V2911852251A8, V291185324870, V29118539F6A3, V29118546435C, V29118549BBAB, V291185632741, V2911856453FE, V291185676165, V291185700C02, V291185711D8B, V29118587FB75, V291185880382, V29118589120B, V29118596F324, V291186028D7C, V291186192A77, V29118626F8E8, V291186281196, V29118631958F, V29118632A714, V29118636E130, V29118637F0B9, V29118643FB95, V29118650D0D6, V2911865496F2, V29118663C825, V30283017485A, V302830232416, V302830289AC5, V30283046276B, V302830550C28, V30283078E47D, V30283089763C, V302892521181, V30289293A9A8, V30289392E2FD, V3028946953E3, V302897712917, V3028980568FC, V3029003202CE, V30297028E36D, V30297138A069, V302971726853, V30301210EE20, V303012481CD0, V30301348460C, V3030138063E4, V30301762B987, V30315243DBAB, V3031534290FE, V303154655BF4, V303154710408, V30315484D06D, V303155256648, V30315538A475, V30315657E736, V30315667CD5E, V303283360D91, V30328422DE68, V30328477F77D, V303288272C66, V30329007C5AF, V30329199A115, V303299634B45, V303300342F7B, V3033004573FA, V3033123597F1, V30331283166F, V30334344FFFB, V3033444473FE, V303344564934, V303347953D6B, V30344673A84D, V30344703BF99, V30344812FD0F, V30344828783D, V30344856DC4B, V303449794DD0, V303449915B88, V303450032F27, V30346276A5F7, V303462914B58, V30346299C710, V30346300D715, V303463085B5D, V303463832B4E, V3034639774B2, V303464115341, V303464732483, V30346484D3F4, V3034649911C9, V303465516EFD, V30346587BBB3, V303466079A17, V30346614B154, V303469484F47, V303469549CF3, V303469558D7A, V30346989F76E, V303470121E00, V30347044058E, V303471588CE6, V3034717747A1, V30347179AEDF, V303471892D17, V303473910D3F, V30347404018F, V303474136CE8, V303474141857, V303474216592, V30347492B3A1, V30347514428B, V303475312696, V30347866D3EE, V303478683A90, V303478692B19, V303490795A41, V30349082675A, V303491691945, V30349172BE4E, V303491810F1D, V303582046EEB, V3035825364EC, V30358271744E, V30358280E60F, V303583153C66, V30358327351C, V30358339C5BA, V303583577814, V3036028549B6, V303602867B2D, V303602876AA4, V3036028983DA, V3036029007C3, V30360291164A, V3036029224D1, V303602933558, V3036029441E7, V30360295506E, V30360308064F, V3036030917C6, V30360316F6E9, V303603190E1E, V30360324FF93, V30360325EE1A, V30360326DC81, V30360330A06F, V3036033392F4, V30360335F7C2, V303603393DAE, V30360343DFFC, V30360344AB43, V30360351E536, V303603569189, V30360360DED7, V30360361CF5E, V30360362FDC5, V30360363EC4C, V303867822E96, V30387082BE28, V3038711233EC, V30387211EE13, V303873458C53, V303873778529, V303874030200, V30387606E015, V30387641F3CA, V30387672EB39, V303877999526, V30387822859A, V30387846976E, V30388056FA8D, V30388096532D, V30388113909C, V303882137FF8, V3038826557C6, V30388455AB77, V30388498D932, V30388535A57B, V30388567F8D1, V303886012653, V3038879927DF, V303888245255, V3038885148F0, V303889226DBF, V303889613844, V30389030D7D0, V30389043A843, V30389188E5EC, V303891943658, V30389199EDBD, V303902796AEE, V30390298E177, V303903169C15, V30390431571F, V303904373229, V3039049298F4, V30390594A71E, V30390620EAF6, V30390650A7FE, V303907569814, V30390776ABA4, V30390801D8D4, V30390913B8C2, V303909392428, V30390960C751, V303910321A5E, V30391243F367, V30391251C9AD, V3039140342DE, V303914657338, V303915064FAF, V303915311178, V303915473946, V304755366A42, V30475549DFBD, V304755541D80, V30475558D7EC, V30475666FB9E, V3047566812E0, V304756780B38, V30475684429C, V3047568888F0, V30475772FEBE, V3047577851E4, V304757836CFF, V30475835A7A6, V304758429E11, V30475848314B, V30475851B552, V30475933984C, V30475938269F, V30475943D544, V30475952DD15, V304760345520, V304760367632, V3047603767BB, V304760398EC5, V30476143364B, V30476147706F, V304761499911, V304761523E1A, V30479219BA34, V304792222E8F, V3047922668AB, V30479229905C, V30479293DBAE, V304792968C03, V304793720AEB, V30479384EC15, V30479387DE8E, V304793882679, V3061214403D6, V306121625550, V3061216521EF, V30612179F25B, V306121897193, V306142080A24, V306142497CCD, V30614250F8D4, V306142862D9A, V30614288C4E4, V306142905174, V30614322CC12, V30614324A924, V2887096492BB, V288709658332, V28870966B1A9, V28870967A020, V2887096858D7, V28870970CD47, V288709759AEA, V28870978410F, V288709795086, V288709815F06, V288709826D9D, V28875018E796, V28875019F61F, V28875021503F, V288750240792, V28875025161B, V288750262480, V288750273509, V28875028CDFE, V28875029DC77, V2887503149E7, V288750350FC3, V288750363D58, V288750372CD1, V288750401566, V2887504104EF, V288750423674, V2887504327FD, V288750445342, V2887504542CB, V288750467050, V2887504761D9, V288751527570, V2887515364F9, V288751541046, V288751563354, V2887515722DD, V28875159CBA3, V288751607C0A, V288751616D83, V288751634E91, V288751652BA7, V28875166193C, V28875183D481, V290843818AE1, V29084383A9F3, V29084385CCC5, V29084386FE5E, V29084387EFD7, V290843881720, V2908438906A9, V2908439082B0, V29084392A1A2, V29084396E786, V29084397F60F, V290953420625, V29095345729A, V290953464001, V290953475188, V290953547ACB, V290953556B42, V290953601687, V29095361070E, V29095363241C, V2909536450A3, V29095365412A, V2909536673B1, V290953689ACF, V290953698B46, V290953700F5F, V30392180A2F5, V30396087FE7A, V30396092B00F, V3041325284B1, V304134715343, V30413674B156, V30413896184F, V304140222B20, V3041410715E1, V30414252D390, V304142658D47, V304886399CA2, V30489683CBEB, V3048979927B5, V30493957A09A, V3049410309E5, V30494115750B, V30495266F947, V304954365126, V304956192FD9, V304956281438, V304998031E74, V305002913528, V305005544720, V30500879500A, V305010732529, V305590951983, V3056043472B4, V30560435633D, V305605172943, V30560612918A, V30560650D5F8, V3056080389C0, V305608906C43, V30560931DA66, V30562219754E, V305723779978, V305818529BF2, V288704204C80, V28872794381E, V288727952997, V288727961B0C, V288727970A85, V28872800E3E5, V28872802C0F7, V288728097E24, V28872814BC19, V288728169F0B, V2887281967FC, V28872821C1DC, V28872823E2CE, V28872830C98D, V28872833FB16, V288728359E20, V28872843B61E, V28872844C2A1, V28872845D328, V288728518CD4, V28872852BE4F, V288728629427, V28872864F111, V28872867C38A, V28872871BF64, V288728728DFF, V28872879332C, V288729182CA9, V28874850D6C7, V28874857A278, V288748585A8F, V303288263DEF, V30330203C414, V3033420919A2, V28875158DA2A, V3039607994CC, V30413876825F, V30560437402F, V30560801AAD2, V30560956FA09, V305820156B22, V30582155569E, V30583354EE14, V2887467968AD, V2887468076A4, V28874681672D, V2887468255B6, V28874683443F, V288746843080, V288746852109, V288746861392, V28874687021B, V28874689EB65, V288746906F7C, V288746917EF5, V288746924C6E, V288746935DE7, V288746942958, V2887469538D1, V288746960A4A, V288746971BC3, V28874698E334, V28874699F2BD, V28874700E2B8, V28874701F331, V28874702C1AA, V28874703D023, V28874704A49C, V28874705B515, V28874706878E, V288747079607, V288747086EF0, V288747097F79, V28874710FB60, V28874711EAE9, V28874713C9FB, V28874714BD44, V28874715ACCD, V288747169E56, V288747178FDF, V288747187728, V2887471966A1, V28874720D108, V28874721C081, V28874722F21A, V28874723E393, V28874724972C, V2887472586A5, V28874726B43E, V28874727A5B7, V288747285D40, V28874730C8D0, V28874731D959, V28874732EBC2, V28874733FA4B, V288747348EF4, V288747359F7D, V28874746E0EE, V288747480990, V28874752BF12, V28874756F936, V2887475901C1, V28874760B668, V28874761A7E1, V288747683A20, V28874770AFB0, V288747728CA2, V288747739D2B, V28874774E994, V28874775F81D, V28874776CA86, V28874777DB0F, V2887477823F8, V288747793271, V288747802C78, V288747813DF1, V288747820F6A, V288747831EE3, V288747857BD5, V2887478758C7, V28874788A030, V28874789B1B9, V2887479035A0, V288747912429, V288747947384, V28874795620D, V28888553E6EB, V28888562DD0A, V28888573D55B, V2888857682F6, V2888858710B7, V290847573CCE, V29084758C439, V29084759D5B0, V290847617390, V29084762410B, V290847635082, V29084764243D, V2908476535B4, V29084766072F, V29084768EE51, V290847707BC1, V290847716A48, V2908477258D3, V28874771BE39, V28874793073B, V2888855583DD, V28888560FE18, V28888561EF91, V28888563CC83, V290846576612, V290846589EE5, V290846598F6C, V2908466038C5, V29084661294C, V29084697CFB2, V290846983745, V2908469926CC, V2908470036C9, V290847012740, V2908470215DB, V290847030452, V2908470470ED, V290847056164, V2908470653FF, V30423267E4B8, V30423337C0DC, V30423340F96B, V30423341E8E2, V30423345AEC6, V304233478DD4, V30423351F13A, V30423361DB52, V304233648CFF, V304233684693, V30423370D303, V304234199617, V304234264488, V304234506CB6, V304234524FA4, V30428010A8A2, V30428100EBA6, V30428112D16C, V30428128545E, V30428174E08A, V30428188A92E, V3042820227D0, V304322297D59, V3043224386D3, V30432250AD90, V3043228891A0, V304322988878, V30432303BB6F, V30432340EE94, V304323468BA2, V30432350F74C, V30432353C5D7, V304324331D02, V30432438A3D1, V30432443500A, V304324859C9C, V30432497A656, V304325005F2D, V304325235E06, V304325307545, V3043253701FA, V30432593BAAE, V30432602935B, V30432607C4F6, V304326494AE8, V30432653FC6A, V30432657BA4E, V30432698EB19, V30432700EA95, V304327068FA3, V30432723EBBE, V3043272944E4, V30432730C0FD, V30432752B73F, V30432775F030, V3043279658BB, V30432842E420, V30432846A204, V30432851CF63, V3043287799E5, V3043289166C3, V3043289703F5, V304329197E97, V304329248F1A, V30432935874B, V30432944DBCA, V30432955D39B, V3043295919F7, V304329628D4C, V304330401D4B, V304330454AE6, V304330489103, V30433081A562, V304330838670, V3043308838A3, V304331267671, V304331333804, V3043313886D7, V304331404797, V3043316346BC, V304331742BDB, V304331753A52, V304331978350, V30437205EAD2, V304372280287, V30437233A58C, V30437236F221, V304372381B5F, V304372390AD6, V30437240DA1F, V30440538F0A7, V30440579864E, V304405919016, V304406029AF1, V3044074195D6, V304407509D87, V30440757E938, V30440771BFBE, V304409168FCA, V30440921D11D, V30440937ADF3, V30440944D260, V30441119AD44, V30441129872C, V304411462B0B, V30441159CA24, V30443352F839, V304433687D0B, V304433842D77, V304434031B0D, V30443642D85C, V30443740A192, V30443744E7B6, V30443747D52D, V304440111587, V3044402579CB, V3044414754D5, V2909534134BE, V290953503CEF, V29095358B0A7, V305001089095, ***update January 2024 *** V304755366A42, V30475549DFBD, V304755541D80, V30475558D7EC, V30475666FB9E, V3047566812E0, V304756780B38, V30475684429C, V3047568888F0, V30475772FEBE, V3047577851E4, V304757836CFF, V30475835A7A6, V304758429E11, V30475848314B, V30475851B552, V30475933984C, V30475938269F, V30475943D544, V30475952DD15, V304760345520, V304760367632, V3047603767BB, V304760398EC5, V30476143364B, V30476147706F, V304761499911, V304761523E1A, V30479219BA34, V304792222E8F, V3047922668AB, V30479229905C, V30479293DBAE, V304792968C03, V304793720AEB, V30479384EC15, V30479387DE8E, V304793882679, V30612179F25B, V306121897193, V306142080A24, V30614250F8D4, V306142862D9A, V30614322CC12, V30614324A924, V28870971DCCE, V28870972EE55, V28870977B9F8, V2887502041B6, V288750327B7C, V288750336AF5, V288750341E4A, V288751643A2E, V28875169E1CB, V288751735749, V290843809B68, V29084384DD4C, V29084393B02B, V29084394C494, V29084395D51D, V290953446313, V29095348A97F, V290953530E74, V290953722C4D, V290953733DC4, V303918094827, V30391949759B, V303920012760, V30392018A379, V303921983765, V3039604311FE, V304134357207, V30413454375E, V30413553193D, V304135908206, V30413617D71D, V30413701F12F, V304138585891, V304140436E79, V30414056200C, V30414257843D, V30414725D39A, V30419201143C, V304885482F47, V30488578052F, V304885945553, V304886404C6B, V304886440A4F, V304886625CC9, V3048870071D7, V304887124B1D, V30488718E447, V304887341D9B, V304887476208, V304896734823, V304896743C9C, V304896761F8E, V304896770E07, V30489682DA62, V30489685AEDD, V304896869C46, V30489692C3BA, V30489693D233, V30489694A68C, V30489695B705, V3048971257A6, V30489713462F, V304897152319, V30489717000B, V304897236C47, V3048972418F8, V304897263BEA, V304897272A63, V30489733759F, V304897340120, V3048973510A9, V304897362232, V30489742291E, V304897433897, V304897444C28, V304897466F3A, V3048975013D4, V3048975230C6, V30489753214F, V304897554479, V3048976039BC, V304897647F98, V304897656E11, V304897665C8A, V304897746640, V304897764552, V3048977754DB, V30489778AC2C, V30489795EDD9, V3049382485D5, V30493892044B, V30493962DD5F, V304940603572, V304940647356, V3049406562DF, V30494113103D, V304941277C71, V304941617E27, V3049417521DB, V30495245F86C, V3049543740AF, V30495438B858, V30495448F550, V30495459FD01, V304954705370, V3049554200D6, V30495559A7DD, V304955711825, V30495615E5B5, V30495616D72E, V30495617C6A7, V30495643FE3B, V304956817489, V30495698F090, V30495714AEE0, V3049942836B4, V30499482649E, V30499498D21C, V30499512E95A, V304997532A0B, V304997674647, V304997839A73, V305000172B66, V305001023FCF, V30500113379E, V305002738C2A, V3050031293AF, V30500323A84E, V3050057211A6, V3050058383E7, V30500605C775, V30500850FE7B, V30500863E688, V3050089411FF, V305010633CF1, V305010666B5C, V3050108909BB, V30501370F8D6, V305013861E28, V305014012852, V30501418AC4B, V30558986B265, V30558991DF02, V30560798AACC, V305608458B96, V305609079538, V30560970AC8F, V30561911F56D, V305620037674, V3056207885AF, V30562127593C, V305621443F77, V30562236BE09, V3057238539A2, V30572393454C, V30572459CFB3, V305724886E42, V305725043032, V30572519F20F, V30572529D867, V305725467440, V30572584FEF2, V30572607EDCD, V305726579375, V30572677A0C5, V30572710DA76, V30572721E197, V3057278779D1, V3057280198E0, V305728283691, V30572940B4D5, V30572941A55C, V3057294297C7, V30572943864E, V30572944F2F1, V30572945E378, V30572946D1E3, V30572947C06A, V30572957D9B2, V305730005310, V305730260596, V30573049A9B1, V305730818C59, V305730919581, V30573092A71A, V30581373906D, V30581382022C, V305813947EC2, V3058140425DF, V305814107A23, V3058142362D0, V305814340FB7, V305814362CA5, V305814545B67, V3058146126A2, V3058147468D7, V305815175440, V305815244CB3, V3058153544E2, V305815427D55, V305815515616, V3058155401BB, V305815635F6C, V305815770090, V305815896A26, V30581595B992, V30581607A2FC, V30581627914C, V305816528BE9, V305816709B4B, V30581681090A, V3058173285E5, V30581745BC52, V30581761C9C6, V30581822D6FA, V30581823C773, V30581824B3CC, V30581825A245, V3058182879A0, V30581837988F, V30581844E71C, V30581863A013, V305818681EC0, V30581874CD74, V305818855F35, V305818945764, V30581952C12E, V30581954A418, V30581963FACF, V30581967BCEB, V305819758621, V305819863772, V305819915A15, V305819962EAA, V3058202450C3, V305820311EB6, V3058203992FE, V305820505BEF, V30582063431C, V3058207179D6, V305821251B96, V30582131446A, V3058213630D5, V305821445ECF, V30582171230A, V30582186D47D, V3058325697DA, V3058328404B0, V305832851539, V3058328627A2, V30583287362B, V30583288CEDC, V305832905B4C, V305832941D68, V30583302F59A, V3058331598FD, V305833286970, V30583335AB4D, V30583345E645, V30583364C47C, V305833922282, V305834041CA9, V3058341514F8, V305834260C0B, V3058343615D3, V305834474952, V305834600E5D, V305834688215, V3058347672B3, V30583532092B, V305835442115, V3058355438CD, V305836178252, V305836196B2C, V30583622FF97, V305836258B28, V305836491594, V305837139EAA;

Distribution pattern

Domestic: AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, ME, MI, MN, MO, MS, MT, NC, ND, NH, NJ, NV, NY, OH, OK, OR, PA, TN, TX, VA, VT, WA, WI, WV, & WY. Foreign: Australia, Austria, Bangladesh, Brazil, Canada, China, Denmark, Egypt, France, Germany, Hong Kong, Hungary, India, Israel, Italy, Japan, Malaysia, Mexico, Myanmar, Philippines, Qatar, Serbia, Singapore, Taiwan, Thailand, Turkey, UAE, & UK.

device · product 3 of 6

Philips BiPAP V30 Auto, Rx Only. To provide noninvasive ventilation support for patients with obstructive sleep apnea syndrome (OSA) and respiratory insufficiency.

Z-1656-2022
Recall number
Z-1656-2022
Initiated
August 26, 2022
Classification
Class I
Status
Ongoing
Recalling firm
Philips Respironics, Inc.
Quantity
295 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Motor assemblies manufactured with nonconforming plastic that contributes to off-gassing of VOCs.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Motor assemblies manufactured with nonconforming plastic that contributes to off-gassing of VOCs.

Code information

UDI-DI: 606959039377, 606959067936; Model No.: 1111155, 1111178; Serial No. N2908453138CE, N290845949213, N2909527493F9, N286646884854, N28664691CC4D, N28664692FED6, N28664693EF5F, N286646949BE0, N286646958A69, N28664696B8F2, N28664697A97B, N28664698518C, N286646994005, N286647005000, N286647014189, N286647027312, N28664703629B, N286647041624, N2866470507AD, N2866470724BF, N28664708DC48, N288710497A15, N28871061C5ED, N28871062F776, N28871063E6FF, N28888622D550, N28888623C4D9, N28888624B066, N28888625A1EF, N288886269374, N2888862782FD, N288886287A0A, N28888630EF9A, N28888631FE13, N28888632CC88, N28888633DD01, N28888634A9BE, N28888635B837, N288886368AAC, N288886379B25, N2888863863D2, N28888639725B, N28888640A292, N28888641B31B, N288886428180, N288886439009, N28888644E4B6, N28888645F53F, N28888646C7A4, N29084339625F, N29084340B296, N29084341A31F, N290843429184, N29084343800D, N29084344F4B2, N29084345E53B, N29084346D7A0, N29084347C629, N290843483EDE, N290843492F57, N29084350AB4E, N29084351BAC7, N29084352885C, N2908435399D5, N29084354ED6A, N29084355FCE3, N29084356CE78, N29084357DFF1, N290843582706, N29084359368F, N290843608126, N2908436190AF, N29084362A234, N29084363B3BD, N29084364C702, N29084365D68B, N29084366E410, N29084367F599, N290843691CE7, N29084520309F, N290845230204, N290845256732, N290845274420, N29084528BCD7, N290845357EEA, N290845364C71, N29084539B486, N2908454175C6, N2908454356D4, N2908454533E2, N29084548E807, N290845525E85, N290845552A3A, N2908455618A1, N290845570928, N29084558F1DF, N29084559E056, N2908456057FF, N290845614676, N2908456274ED, N290845636564, N2908456411DB, N290845650052, N2908456632C9, N290845672340, N29084568DBB7, N29084569CA3E, N290845704E27, N290845715FAE, N290845726D35, N290845737CBC, N290845740803, N29084575198A, N290845762B11, N290845773A98, N29084578C26F, N29084579D3E6, N29084580CDEF, N29084581DC66, N29084582EEFD, N29084583FF74, N290845848BCB, N290845859A42, N29084586A8D9, N29084587B950, N2908458841A7, N29084589502E, N29084590D437, N29084591C5BE, N29084592F725, N29084593E6AC, N29084595839A, N29084596B101, N29084597A088, N2908459949F6, N29084600EC4B, N29084601FDC2, N29084602CF59, N29084603DED0, N29084604AA6F, N29084605BBE6, N29084606897D, N2908460798F4, N290846086003, N29084609718A, N29084610F593, N29084611E41A, N29084612D681, N29084613C708, N2908461690A5, N29084617812C, N2908461879DB, N290846196852, N29084620DFFB, N29084621CE72, N29084622FCE9, N29084623ED60, N2908462499DF, N29084626BACD, N29084627AB44, N2908462853B3, N29084629423A, N29084630C623, N29084631D7AA, N290952392F7C, N29095240FFB5, N29095241EE3C, N29095242DCA7, N29095243CD2E, N29095244B991, N29095245A818, N290952469A83, N290952478B0A, N2909524873FD, N290952496274, N29095250E66D, N29095251F7E4, N29095252C57F, N29095253D4F6, N29095254A049, N29095255B1C0, N29095256835B, N2909525792D2, N290952586A25, N290952597BAC, N29095260CC05, N29095261DD8C, N29095262EF17, N29095263FE9E, N290952648A21, N290952659BA8, N29095266A933, N29095267B8BA, N29095268404D, N2909526951C4, N29095270D5DD, N29095271C454, N29095272F6CF, N29095273E746, N290952758270, N29095276B0EB, N29095277A162, N290952785995, N29095279481C, N290952805615, N29095281479C, N290952827507, N29095283648E, N290952841031, N2909528501B8, N290952863323, N2909528722AA, N29095288DA5D, N304507466A73, N304507510714, N304507532406, N304507554130, N304508550BF7, N30450858D012, N304508625520, N30450869EBF3, N3045094548F3, N30450951170F, N3045095663B0, N3045101795FC, N304510248D0F, N30451032F1E1, N30451037A64C, N304510913E0A, N30451095782E, N30451098A3CB, N30451101B3CE, N30451159413E, N30451164B0B3, N304511678228, N30451170EF4F, N3045521752A8, N304552211DF6, N304552266949, N30455231042E, N304552770678, N30455280F10F, N30455283C394, N304552869439, N30455308E95B, N30455309F8D2, N304553170874, N30455318F083, N304553554C06, N30455359866A, N304553630358, N30455365666E, N30455385FC7E, N30455386CEE5, N30455390B20B, N30505287A7CF, N30505346453A, N305053547FF0, N305053632127, N305053711BED, N305053777EDB, N30505383BB37, N30505387FD13, N305053909074, N30505395C7D9, N30505978F556, N30506053C1E6, N30506054B559, N30506055A4D0, N3050605787C2, N305060587F35, N305060596EBC, N30506060D915, N30506063EB8E, N305538189694, N30553830296C, N305538357EC1, N3055384533C9, N30553891C595, N30553893E687, N3055389583B1, N30553896B12A, N305539430C23, N305539474A07, N30553949A379, N3055395570CD, N305539881B50, N305539919F49, N30553996EBF6, N305539991301, N30554041E40E, N30554043C71C, N3055404879CF, N30554051FDD6, N306372146A8B

Distribution pattern

Domestic: AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, ME, MI, MN, MO, MS, MT, NC, ND, NH, NJ, NV, NY, OH, OK, OR, PA, TN, TX, VA, VT, WA, WI, WV, & WY. Foreign: Australia, Austria, Bangladesh, Brazil, Canada, China, Denmark, Egypt, France, Germany, Hong Kong, Hungary, India, Israel, Italy, Japan, Malaysia, Mexico, Myanmar, Philippines, Qatar, Serbia, Singapore, Taiwan, Thailand, Turkey, UAE, & UK.

device · product 4 of 6

Philips OmniLab Advanced+, Rx Only. To provide noninvasive ventilation support for patients with obstructive sleep apnea syndrome (OSA) and respiratory insufficiency.

Z-1657-2022
Recall number
Z-1657-2022
Initiated
August 26, 2022
Classification
Class I
Status
Ongoing
Recalling firm
Philips Respironics, Inc.
Quantity
85 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Motor assemblies manufactured with nonconforming plastic that contributes to off-gassing of VOCs.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Motor assemblies manufactured with nonconforming plastic that contributes to off-gassing of VOCs.

Code information

UDI-DI: 606959028791; Model No.: 1109581; Serial No. L28664716B714, L28664717A69D, L286647185E6A, L286647194FE3, L28664720F84A, L28664721E9C3, L28664722DB58, L28664723CAD1, L28664724BE6E, L28870984130F, L288709850286, L28870986301D, L288709872194, L28870988D963, L28870989C8EA, L288709904CF3, L288709915D7A, L288709926FE1, L288709937E68, L288709940AD7, L288709951B5E, L2887099629C5, L28870997384C, L28870998C0BB, L28870999D132, L288710001B4E, L288710010AC7, L28871002385C, L2887100329D5, L288710045D6A, L288710054CE3, L288710067E78, L288710076FF1, L288710089706, L28871009868F, L288710100296, L288710122184, L28871013300D, L2887101444B2, L28871015553B, L2887101667A0, L288710177629, L288710188EDE, L288710199F57, L2887102028FE, L288710213977, L288710220BEC, L288710231A65, L288710246EDA, L288710257F53, L288710264DC8, L288710275C41, L28871028A4B6, L28871029B53F, L288710303126, L2887103120AF, L288710321234, L2887103303BD, L290846327ECB, L290846336F42, L290846341BFD, L290846350A74, L2908463638EF, L29084638D191, L29084639C018, L2908464010D1, L290846410158, L2908464233C3, L29084643224A, L2908464456F5, L2908464675E7, L29084647646E, L290846489C99, L290846498D10, L290846500909, L290846511880, L290846522A1B, L290846533B92, L290846544F2D, L290846555EA4, L290846566C3F, L303986996DE3, L30398708F1AE, L3039884141C8, L304097046ACC

Distribution pattern

Domestic: AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, ME, MI, MN, MO, MS, MT, NC, ND, NH, NJ, NV, NY, OH, OK, OR, PA, TN, TX, VA, VT, WA, WI, WV, & WY. Foreign: Australia, Austria, Bangladesh, Brazil, Canada, China, Denmark, Egypt, France, Germany, Hong Kong, Hungary, India, Israel, Italy, Japan, Malaysia, Mexico, Myanmar, Philippines, Qatar, Serbia, Singapore, Taiwan, Thailand, Turkey, UAE, & UK.

device · product 5 of 6

Philips OmniLab Advanced+ Intl (Flow Gen), Rx Only. To provide noninvasive ventilation support for patients with obstructive sleep apnea syndrome (OSA) and respiratory insufficiency.

Z-1658-2022
Recall number
Z-1658-2022
Initiated
August 26, 2022
Classification
Class I
Status
Ongoing
Recalling firm
Philips Respironics, Inc.
Quantity
34 units ***updated January 2024 *** additional 3 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Motor assemblies manufactured with nonconforming plastic that contributes to off-gassing of VOCs.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Motor assemblies manufactured with nonconforming plastic that contributes to off-gassing of VOCs.

Code information

UDI-DI: 606959029415, 606959028791; Model No.: 1109582, 1109585; Serial No. L28664715858F, L286647269D7C, L286647278CF5, L28870204F469, L28870206D77B, L28870207C6F2, L288702092F8C, L28870210AB95, L28870211BA1C, L288702128887, L28870214EDB1, L28870215FC38, L28870216CEA3, L28870217DF2A, L290843744520, L2908437554A9, L290843766632, L2908437777BB, L290843788F4C, L290843799EC5, L30396148EE55, L3039822431CF, L3039826456AF, L303982733BC8, L3039831335C4, L303983231FAC, L30398354261B, L30398416EE6C, L30398476BABC, L303984836ED9, L30398524BDCA, L30398531F3BF, L3039856810C6, L28664713E0B9; ***January 2024 Update *** L28664709563B, L28664710D222, L28664712F130;

Distribution pattern

Domestic: AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, ME, MI, MN, MO, MS, MT, NC, ND, NH, NJ, NV, NY, OH, OK, OR, PA, TN, TX, VA, VT, WA, WI, WV, & WY. Foreign: Australia, Austria, Bangladesh, Brazil, Canada, China, Denmark, Egypt, France, Germany, Hong Kong, Hungary, India, Israel, Italy, Japan, Malaysia, Mexico, Myanmar, Philippines, Qatar, Serbia, Singapore, Taiwan, Thailand, Turkey, UAE, & UK.

device · product 6 of 6

Philips OmniLab Advanced + with Heated Tube Humidifier, Rx Only. To provide noninvasive ventilation support for patients with obstructive sleep apnea syndrome (OSA) and respiratory insufficiency.

Z-1659-2022
Recall number
Z-1659-2022
Initiated
August 26, 2022
Classification
Class I
Status
Ongoing
Recalling firm
Philips Respironics, Inc.
Quantity
8 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Motor assemblies manufactured with nonconforming plastic that contributes to off-gassing of VOCs.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Motor assemblies manufactured with nonconforming plastic that contributes to off-gassing of VOCs.

Code information

UDI-DI: 606959067837, 606959068001; Model No.: 1111124, R1111124; Serial No. L29084645477C, L303986771E8D, L303987043BC2, L3039871356A5, L30398768A57E, L303987892EE7, L30398795FD53, L30398849CD80

Distribution pattern

Domestic: AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, ME, MI, MN, MO, MS, MT, NC, ND, NH, NJ, NV, NY, OH, OK, OR, PA, TN, TX, VA, VT, WA, WI, WV, & WY. Foreign: Australia, Austria, Bangladesh, Brazil, Canada, China, Denmark, Egypt, France, Germany, Hong Kong, Hungary, India, Israel, Italy, Japan, Malaysia, Mexico, Myanmar, Philippines, Qatar, Serbia, Singapore, Taiwan, Thailand, Turkey, UAE, & UK.

Field note

Send feedback

We'll only use this to respond to your feedback.