Philips DreamStation Auto BiPAP and CPAP, Model Numbers UCDSX500S11, UDSX500S11, UDSX500S11F, UDSX700S11, UDSX700S11F, U

Summary

The FDA issued a Class I for Philips DreamStation Auto BiPAP and CPAP, Model Numbers UCDSX500S11, UDSX500S11, by Philips Respironics, Inc.. Reason: A limited number of remediated Philips DreamStation units may experience communication issues when connecting to the cloud-based care management appli.

Details

Product Description

Philips DreamStation Auto BiPAP and CPAP, Model Numbers UCDSX500S11, UDSX500S11, UDSX500S11F, UDSX700S11, UDSX700S11F, UFRX500S14. Used to deliver positive airway pressure therapy for the treatment of Obstructive Sleep Apnea.

Lot/Code Info: GTIN/HIBC: HIBCUCDSX500S11, GTINUDSX500S11F, HIBCUDSX700S11, GTINUDSX700S11F, GTINUFRX500S14; Serial Numbers: J24421197E010, J201506009824, J20558590552C, J21032984C317, J21209966AF9A, J217958772FC0, J232909614499, J232986192AC6, J239466352C09, J26991149FC9E, J285824687E46, J169457430155, J18040704DF8F, J181773679463, J18342322DF63, J185233902700, J18531602D885, J185960074278, J186478392B1E, J186751020701, J187324621476, J188283663434, J18833555314F, J188893710940, J188945627411, J18897822C9C3, J1891938599E3, J18951421667A, J189800136CAE, J19017668F54F, J190409177B02, J1906385333DF, J190720281139, J19096115A93C, J19100094327C, J19295259C6CF, J193008337527, J19336718E4D5, J193380465154, J1934276067A5, J19397348A91F, J193977064460, J194128342F7B, J19434423BAAD, J19438211F23A, J194617995638, J19560765070C, J19572114BF66, J19599936C8AB, J196015973930, J196616324711, J196622212AFE, J19663444E3E1, J19681407EED4, J196887815325, J19693965545B, J197027417820, J19740100CC76, 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J30688853C0DE, J306932642622, J307037644AD0, J30715542E930, J30724733017E, J30731535B4E3, J30736431FF3A, J30753987D414, J30755249F6F6, J307677155F25, J30776147C3A9, J30792385EFF7, J30818592EF4E, J30832030C2B7, J3083606488C7, J30836125A4F2, J3086393175CF, J30864897E074, J30881443BC64, J30908832E22E, J3091314946BA, J30914479024E, J30915880A55F, J30928605BA6A, J30977782CE64, J31086232DF90, J1801311367A8, J1879353737AC, J18909076CC90, J191461469D40, J1914690059D4, J192679666E7C, J1955583106CC, J19865472DE87, J202919807BD5, J204092716C74, J20633696288E, J20656736DAED, J2098761807B9, J211869226A7A, J215019351AB0, J21566882BCC2, J21630513E49F, J21641423B84C, J2176985908C6, J21791930142F, J2219403056F2, J2243256776FD, J22509283FF3E, J22530254DF56, J226477679598, J22693095B7DF, J2269508380AB, J229985738CD8, J23272116E322, J233672714D11, J23439636A968, J238582915511, J239929365ACD, J2419040035DA, J2419141213AB, J2420160487E4, J24451339717A, J24687315B71E, J24689562F632, J248344607A3D, J248746458688, J248746778FF2, J249907738475, J253506532CF2, J25457517A922, J259701988802, J26018417D4D5, J26020925DAC4, J26134334DC6C, J2618045612AB, J26282630A3FE, J26537479D98D, J2655104709F8, J2662339642BA, J2685171388BE, J268901894DAE, J273100093162, J274346417426, J27442420FF81, J27730229B14E, J278397683AF0, J28163984BCEA, J2829465477F5, J283310458FA9, J28408840E6B8, J285175592048, J2882100904C4, J295970472CA6, J296838328514, J297021622502, J29798522ACC9, J29818282BA15, J29843664C013, J299381308068, J300338330B0D, J30132053818F, J30163729D537, J3026199198C7, J307216886F8E, J30857881A49B, J18793356A42C, J1886431394B5, J188794309950, J18957760B46D, J190653032F5B, J1911452496C1, J19116077DA29, J19193154B5A9, J19200040C85D, J19202796A860, J19228307C7B6, J19344435EA4E, J1939327753B0, J195854813BB3, J19618243B14E, J197585353C4E, J197762993F9D, J19912280CB52, J1998871935FC, J20102806F22B, J20312876BC31, J204192752114, J20490118E206, J205340177A42, J20557841B95B, J206189176B9D, J207587030D41, J2079832985FA, J20799658FC7D, J2080529373B6, J20873741A227, J20943812BD24, J209487088174, J20953059A911, J212639721750, J21554512B01F, J215641284B80, J2161393162DB, J218413099101, J22029571D1EE, J2204257218F8, J220439059857, J2222197199C3, J222929669685, J223353901CA3, J223728597B55, J223793016016, J224254710CAA, J22449035E223, J22522761A91C, J22687851E731, J227770355DD0, J229099434ECC, J22922088133C, J232113175946, J23231724345C, J23235608E5B0, J23256292E0C6, J232753350090, J23347420E271, J23491410E326, J23492385CA5B, J23508346D881, J235395167197, J235666160A5E, J2364222519D5, J237296169DE1, J23862568067F, J24261334AFA9, J2427942092CC, J2437640234BC, J243840388165, J2439258090E6, J24411368335B, J24562617AE23, J24578801153C, J24690824F93C, J246947843C67, J247646905790, J24849684A8E2, J250336703FF1, J251357589564, J252884413E07, J2528993190CB, J25498049C290, J25537599B12F, J25574287C551, J25839903F753, J2584255973DB, J2593590410F3, J2599642787C2, J2637383487AD, J2642862474FE, J264304050DE3, J26441079C581, J26447923C3E7, J26456640F894, J265243549354, J2659268273D1, J268099712CEB, J26820438C6DE, J26850660B14A, J268560599BA0, J2688698501DE, J27015679C899, J27079803967C, J27162697D821, J2717324179F1, J27561949FE81, J27565294CE56, J278248210A5D, J280009300418, J28119860D670, J28139538CD77, J28331104A39C, J28452918B46E, J284772124A4D, J289011159F0F, J28932433C835, J29048730431E, J29066665881D, J29217307E253, J29219025B3D7, J294371075999, J29478171EE4E, J29553539B4B1, J2960514245B8, J2968178566B2, J297387306F13, J297537182B66, J29841486F5DF, J299134744E0C, J29930227E7B3, J30062071B352, J30153450F756, J30167174D45F, J303510680337, J303656893157, J304149407F47, J3050903209A3, J305194501644, J30791795B083, J30824989671E, J30877708ABD5, J3096462175DA.

Quantity Affected: 1233 devices

Reason for Recall

A limited number of remediated Philips DreamStation units may experience communication issues when connecting to the cloud-based care management application. Should this be the case, this may affect the ability to download prescription settings to the device or the device may have incorrect prescription settings for the patient.

Type: Voluntary: Firm initiated

Recall Initiated: 2023-02-10

Company