Z-1656-2022 Class I Ongoing
FDA device recall Z-1656-2022 was initiated by Philips Respironics, Inc. on Aug 26, 2022 and is designated Class I. Reason for recall: Motor assemblies manufactured with nonconforming plastic that contributes to off-gassing of VOCs. The recall status is ongoing. Affected quantity: 295 units.
Recall Details
- Product Type
- Devices
- Report Date
- Sep 14, 2022
- Initiation Date
- Aug 26, 2022
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 295 units
Product Description
Philips BiPAP V30 Auto, Rx Only. To provide noninvasive ventilation support for patients with obstructive sleep apnea syndrome (OSA) and respiratory insufficiency.
Reason for Recall
Motor assemblies manufactured with nonconforming plastic that contributes to off-gassing of VOCs.
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.
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
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1656-2022
- openFDA file date
- Oct 6, 2026
- Loaded by RegDataLab
- Oct 12, 2026