Device product
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
Product summary
- Event
- Event 90695
- Status
- Ongoing
- Classification
- Class I
- Quantity
- 295 units
- Official record key
device-enforcement:Z-1656-2022
Official wording
Reason: 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.
Derived failure modes
-
Unknown
Motor assemblies manufactured with nonconforming plastic that contributes to off-gassing of VOCs.