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Philips Respironics, Inc. Recall 90695

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

Philips Respironics, Inc. Recall 90695 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-1656-2022
Event ID90695
Event DescriptionPhilips BiPAP V30 Auto, Rx Only. To provide noninvasive ventilation support for patients with obstructive sleep apnea syndrome (OSA) and respiratory insufficiency.
Product TypeDevices
DistributionDomestic: 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.
Quantity295 units
Recall ReasonMotor assemblies manufactured with nonconforming plastic that contributes to off-gassing of VOCs.
Device Classification20220914
Device Code InfoUDI-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
Center Classification Date20220908
Recall Initiation Date20220826
Recalling FirmPhilips Respironics, Inc.
Initial Notification Letter
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