Philips DreamStation Auto BiPAP and CPAP…

Date

April 12, 2023

Risk class

Class I (FDA's definition, 21 CFR 7.3(m): a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death)

Status

Ongoing

Filed by

Philips Respironics, Inc.

Product

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.

Reason

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.

Distribution pattern

US Nationwide. France, Reunion.

Quantity

1233 devices

Codes and lots

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, J197462035A13, J19829225B87D, J198893618F4D, J19897823479F, J199489094B0F, J1995244188B2, J19955891CA48, J19974649EC50, J199812928531, J20000673C5C8, J200098723D39, J2002398779A6, J20024924E16C, J20028156DE80, J200315005448, J200330776D34, J20037996085F, J200434543FA2, J20046333FD9F, J200784608E37, J2008236386FB, J200955326376, J200963568296, J20098641780E, J20101914B7F0, J20132862FD13, J201332782450, J20133289B611, J201347927F86, J20151256FC70, J20155655DF66, J201592088E6E, J201721030944, J20181184FC0A, J2018336820B8, J201995248C87, J20205698870A, J202080815E45, J202151242E8F, J202321637CF9, J20246389BE3B, J202483788238, J20251842DC8B, J20272913DA23, J20273063178E, J202740706BEC, J20288502C183, J203041243D5B, J2030604738BA, J203145426498, J2031848023C2, J20331360DA3C, J203530510C57, J20356484E6B4, J20364395465A, J20413483CD9D, J20431989B246, J204434626050, J20470617F74C, J204743922570, J204980932D11, J20500901F592, J2051784085C2, J2054895360F0, J20552371D4C2, J20574522132A, J20575270DE3E, J206521624644, J206526595EFA, J20652834C1D4, J20686774E2EB, J207048800ABD, J207334130070, J207448831536, J20790320FDE3, J20793574366B, J20809177D7D2, J20809588CF8C, J208195862DB6, J20834788EC77, J20840804E02C, J208408549E94, J20849026CF2F, J208503815BA3, J208672392372, J20871479D215, J2087626491D0, J20876271DFA5, J20882726F40F, J20919298553E, J20927315A949, J20934312F37F, J20940168E6A5, J20952192F805, J20990200AD2D, J2101805351E8, J210318222440, J21034463995D, J21037319D2C7, J210536245383, J21055161A4D1, J210620078506, J210720197EE4, J21090173877C, J210965492AB5, J2110676356A8, J211532512E6C, J211769736FB7, J21199626DF24, J212361830BD0, J21242878E8E5, J21257083762F, J21263239E745, J21264421F32D, J212672245794, J21267683BD3A, J21285838AF94, J21302488E7B5, J213072535190, J21335563D347, J21340557E180, J21358721929A, J21358872947E, J21383893A386, J21406560C50C, J214147517967, J21417507F29C, J2148770241ED, J214918603C36, J215012981583, J215014684092, J21510779B058, J2151680242DE, J2151906373BC, J2151913711FC, J215207664CBB, J2152659366FC, J2153511580E2, J2153635577F7, J21577067A042, J215867007A6F, J21596067DD41, J216063645DA7, J21610669FF21, J216376544F05, J21642369D9BE, J21647959EEFB, J21659448BCD3, J216651864F48, J216742220C87, J21680293E1B6, J21704697E814, J21705151B43C, J217178577F26, J217225783885, J217259442A03, J21727567B7FD, J217278125227, J217453062693, J217458433FF8, J21838957BC02, J218522555180, J21875960444A, J21883638DD1B, J2188807466DB, J218903205FBF, J219558600C35, J219610931484, J21961462E5A4, J219651876348, J219652878C2C, J219676236D6F, J219682679DB3, J21976105A013, J219872125457, J21989356818D, J21992328EEAA, J22006500291E, J2200747575DC, J220094618462, J22018754013C, J220255133118, J22051469CBA6, J22064966BFB5, J22124602CEBD, J221354503150, J22145548CEC0, J22165479B975, J22178443BC8C, J22189435E2F5, J22190657D2A8, J22295509C820, J2230847810BD, J2230923477D3, J2231504144BE, J2231909340E0, J223873485E09, J223884914D4C, J223935443B14, J22393800E52F, J22423671F288, J22443311A47D, J224536239FFE, J22455183A511, J22456510063E, J22462636D0FC, J22471302AB84, J2247301733E3, J2248003218CF, J22482079F80A, J22491510262F, J224928782405, J225108840ADC, J2252238041E4, J225371600B5F, J225392741585, J22539473B7E3, J22542038FDF8, J2254785801BD, J22556083DE2B, J225926847991, J225970689163, J22608713015D, J226230363FD8, J226263913724, J22633454203F, J226340156296, J226738293E61, J22677251FEB7, J2270231199AB, J227034302B2C, J22715184F0C3, J2275937219A1, J227626329AA5, J22766270CF5A, J22769552E104, J2277649088D7, J227889107DD6, J2280456600D6, J228064699B8B, J22831212F464, J228333290375, J22833485B86C, J2286171844D7, J22871967EA77, J22874682035A, J22882302D541, J22892798C526, J22909809DC2A, J22914773F474, J22916529A958, J22931095FF88, J22936849147F, J229545524EE5, J229552685B69, J22958502A769, J230026399CEA, J2301719761F2, J230249624B54, J23027374610D, J23028262F5C6, J23034534FE3D, J230410358882, J23046354759E, J23052794C6F7, J230648026848, J230762110243, J230769643140, J230859477F5A, J23102613042B, J231056883AC1, J23111115C391, J2311591754AD, J23121030E09C, J231245586FEE, J23127929B301, J231401595472, J23144031A4DA, J231441989EB7, J23152166B4DF, J23194968A7C9, J23195143F0D3, J232053015C00, J232078980609, J23227523B585, J23231918C443, J23244220154E, J232492669C97, J23249758663C, J23254004DE26, J232540937D81, J232560585384, J23258396527C, J2326481279C6, J23280006F3AC, J23281783FA7F, J23281958E4CF, J232872544C9F, J232874797213, J232885990026, J23289073106A, J232948245C64, J23301665018E, J233033507C80, J2331330118F5, J233180355BC8, J23323981B883, J233327929424, J23337738A859, J23342428006E, J23370162D553, J23428841973B, J234361619D93, J234651619E0A, J23466527DAF0, J23488601ACE8, J234938161AC5, J234979342257, J23500932450F, J235023561DF7, J235026979C63, J23506132C857, J23506135BCE8, J235071094057, J2350840275C0, J235120384479, J235215249671, J23526410F7C0, J23529012054A, J23532338BD95, J23532819B60A, J235359427B9C, J235567526C0A, J23560884A5D5, J23634739889A, J23648753D4F8, J23655338DD51, J23686115D905, J23695430AA2C, J237175595E9C, J237408164F01, J2374315691B2, J237558050151, J237784477D87, J237939146F76, J23794160F5B9, J2379520271A4, J23799960B8F4, J23815953509A, J2382359129DD, J2382491553BB, J23858081F971, J23860383CD13, J23876026C874, J238902417781, J238943121392, J239173809C5E, J239331008342, J239354284E9D, J239358137F85, J23951144A0E8, J239570478335, J23958261D2F2, J239760119288, J23986881E9AE, J23995783AEF2, J24003130568D, J240038491A5A, J24021195D3AE, J240271032A1A, J24097894524F, J24098829DFFB, J240996522080, J24100352B511, J241049875352, J241096897B64, J241139834913, J241312139853, J24144257E79C, J24150252C999, J24183823BFDB, J24184027681C, J24204998BE00, J24246873D479, J24259542A95A, J243032239ED7, J2432305515D9, J243309080213, J24340698AF10, J24346988B795, J2435766870BD, J243979568E5C, J24405992151B, J2442289759C3, J244396075591, J244563293F83, J24469391F856, J24486486CA75, J244999103E99, J245076758C2E, J245115266FB7, J24511889954F, J24518026AF69, J24528681EDB3, J245627597AE1, J245713049254, J245715525F03, J245908292EA4, J2459316608E0, J246077095DEB, J24633069EA1E, J246363308854, J246383176119, J24638431BB9A, J246496257DB9, J2466270819AD, J24663046070D, J246664033AF6, J246817801F50, J2468179440AC, J2470849408A0, J247183542641, J24720833D79C, J2472825315EE, J24735764F24F, J2475036082C5, J247534838386, J247566842CD6, J247672681EBC, J247733068066, J24781336F984, J2478206028A3, J247863097C3A, J247897389643, J2479362802AD, J2479670089DE, J248164357CD6, J24817121062C, J24821274960B, J2484314017CD, J248615200F82, J248857785B9E, J24897661B769, J24898913214D, J249074714E46, J249204818C27, J249225997A1D, J24927051081F, J2495098726B2, J249524677AAB, J24955997513D, J249586102A0A, J2495910391F7, J249604721064, J24997874ED2C, J250033502830, J2500805116C8, J250281398204, J2513849583CA, J251414888848, J251433262935, J25154278B84A, J251580421FF4, J25189093DECA, J251891603545, J25190051A65F, J25197396C305, J25197912389B, J252029065429, J25215987D705, J25235287E82B, J252500953296, J25286309F768, J252881993B8A, J2528878178C3, J25292000FC65, J253009055BEF, J2531487173B7, J2532282269C2, J25331782F0FC, J253346311244, J253448203AD2, J25355294FCDB, J253612460091, J25364381E905, J25364390E154, J253816751ABB, J253858373C3E, J25392386BCDC, J25396780C867, J25403589C3FC, J25404349EBA4, J254303401945, J25432051C706, J25439216A174, J254513137245, J254678103F2E, J2548665124DF, J25491761080E, J254956499FC6, J25499493A268, J2550457802B7, J255170988F93, J25535070B635, J25597006EBD5, J256032111CFF, J256094054974, J256177474764, J256218306242, J2562749526A6, J25649635FBB4, J2571640391D4, J25763076B69B, J257826323C05, J25787257324E, J25787986BA19, J25790202473E, J25794160AD74, J258037303ED9, J258058750F49, J25830394DEED, J2583277058CE, J25833717641A, J25838898D8FF, J25848661E631, J2585604294C5, J258633457C85, J258708163789, J258711583932, J25890161F398, J258930681148, J25919806E881, J25929730F0D4, J259462554375, J2597876838CB, J2597900070ED, J25986762532F, J26006898E247, J260328718AB6, J260403179B5C, J260474652E62, J26050943DBFE, J261064374648, J261067168B15, J261265502A73, J26166353E321, J2619438565E5, J26200587BFDB, J26209886A84E, J2622546341EC, J262464299783, J26260712B14E, J2626331492D4, J262656796FC6, J2627253137EF, J26275840C330, J26278576F89E, J26298098D3F5, J26334803A34B, J263380428454, J2633973259E2, J263408845B04, J26341750FB24, J26355903DEB4, J263735144B62, J26382580AC19, J263901277485, J26410935CE7C, J264115751004, J2642809000AB, J26452068E359, J26464356997D, J2647256151AD, J26513319653C, J265223820D80, J2652383962E6, J2653368000D0, J265769583560, J26599552ECD8, J26599766352C, J266040991480, J2660995126F9, J266175062C5B, J26624655B71D, J26645195B59B, J266498175363, J2665058871D4, J26662603CA19, J26670413544B, J2672045646F9, J26728167A17D, J267384852A86, J267387206F3F, J267417338DC3, J267448219399, J267509805C14, J26766031637D, J26771247A29E, J26783124783B, J26788014C89A, J267905981B17, J267951623AB3, J26796190BFA4, J268022392E70, J268106609C5A, J26817756DEF9, J268244111A43, J2683006728B4, J268475430360, J268505256EE3, J268691596E49, J268828092D42, J26910091DCE9, J26944860DCD2, J26949533E401, J269511993BD6, J26952183A899, J2696770694B6, J26972194D376, J269875563E0E, J269948284B8E, J270008893E59, J27005948B2FB, J270076075EDD, J27025470FD2C, J2705093218AA, J27065164B67D, J270691515C8C, J270709176A3F, J27070959E421, J27093542A2FC, J27095282CCC3, J27165768AEE3, J27176062A335, J271856360241, J27195101DBD7, J273519044732, J273743033828, J274029959EEB, J274152263D1B, J27429539DAC9, J274295477EBF, J2745988718BC, J27467846131B, J2747437369F1, J27487620535E, J27494159211B, J275123161EA5, J275127672145, J27529745EC3E, J27556130A267, J2756805893AD, J27568988BFCB, J2757304950AD, J27601608F54A, J276371786211, J276395630839, J27651150ADEB, J2765527220C1, J2766511286B9, J276770528937, J2768316484A5, J27688264ABD4, J2769060034DD, J27691159471A, J2770261373A7, J277149162E13, J277249073B8E, J277332660B14, J277708342D19, J27778582B620, J27803160A103, J278079360EA3, J278118224B5D, J27812388151C, J27815883D548, J27828812859A, J278308370F1B, J27843782E3C8, J2786458472EF, J278681176339, J27882228E3D4, J27882444ABB1, J27883338BC6B, J27901998551C, J27906450D8AA, J2791420261EB, J27918158C859, J279210479705, J27937530D7D1, J27956620064E, J27958298A38D, J27977477B3C2, J27999082CB3C, J28009716BBE6, J281272141DA8, J28136096523D, J2814662035A6, J28149727A93C, J28158314C551, J281628588099, J28163032A16A, J2821677218F9, J28224135F945, J2822415967F9, J28224564F515, J2823955895DA, J28239624FDDA, J28258937BB7D, J2827360079F0, J28277687B163, J28281710697E, J28292227209D, J28294255051D, J283213699255, J283247063344, J283266164936, J28327739C416, J28348231F882, J2835535602FA, J283794111C9C, J28380728D7CE, J28388138FD17, J2838985938EB, J28389998DA1E, J2839137272B2, J2840709201E9, J28416893C15D, J28418245C92B, J2842276413CD, J28423269ED2E, J2842370891CA, J28435564FA10, J28436189FD49…

Recall started

Feb. 10, 2023

Device type

Ventilator, Non-Continuous (Respirator)

Root cause (FDA)

Software design (manufacturing process)

What the company told customers

An Important Product Notice was sent to customers on 2/10/23. For DMEs: 1. Should the prescription settings of the device be affected by this issue, the patient may find the device provides different pressure and comfort settings than the patient is accustomed to. 2. The DreamStation is designed to provide CPAP, CPAP-Check, Auto CPAP, Bi-Level and Auto Bi-Level therapy. Affected product can be determined by locating the serial number of the replacement device and verifying it against the serial number noted in this letter below. 3. Affected device serial number(s) are noted in the letter. Enclosed is the letter that should be provided to your affected patients. Replacement product will be provided to you for exchange of affected devices. 4. If you need any further information or support concerning this issue, please contact 1-800-345-6443, prompts 4, 5 or email at respironics.clinical@philips.com. For Patients: Affected product can be determined by locating the serial number of the replacement device and verifying it against the serial number noted in this letter below. The device may continue to be used until the replacement device is received. The affected device serial number is noted in the letter. Philips will attempt to contact the patient via phone call to set up replacement and return of the device affected by this issue. No further action is necessary by the patient. Philips will attempt to contact the patient via phone call to set up replacement and return of the device affected by this issue. If you need any further information or support concerning this issue, please contact your local Philips representative: 1-(877)-387-3311 or email at patientsupport@philips.com.

Recall number

Z-1322-2023

What should I do? How serious is a recall? Classes and warnings explained

Source: FDA · Medical device enforcement report, recall number Z-1322-2023. The agency record governs; check it and the company before acting.