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FDAFDA · Food and drugs·Recall number Z-1654-2022

Philips BiPAP A30, Rx Only. To provide noninvasive ventilation support for patients with obstructive sleep apnea syndrome (OSA) and respiratory insufficiency.

Published September 14, 2022 · Recall initiated: August 26, 2022

Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.

What's the hazard

Motor assemblies manufactured with nonconforming plastic that contributes to off-gassing of VOCs.

What to do

Voluntary: Firm initiated · Letter

Recall details

Manufacturer
Philips Respironics, Inc.
Distributor
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.
Lot
UDI-DI:606959042667, 606959042681, 606959042698, 606959042728, 606959067585, 606959067530; Model No.: 1109581, 1109582, 1109585, 1109588, 1109589, 1109590, 1109594, 1109596, 1109598, 1109601, 1111124, 1111150, 1111155, 1111169, 1111177, 1111178, 1116153, 1116156, CN1111143, CN1111169, R1111124, R1111177; Serial No.: N287725308B25, N28870219ADAE, N288702267F31, N2887023003DF, N288702473A68, N28870248C29F, N2887025723B0, N28870279F97E, N28870300736B, N2887030162E2, N2887030341F0, N288703153D1E, N288703341F27, N28870339C4C2, N288703423719, N2887034989CA, N288703533F48, N288710382694, N28871040E7D4, N28871042C4C6, N28871043D54F, N28871045B079, N28871047936B, N288710486B9C, N28872243453A, N28872424B38C, N28872434AA54, N30471136FB91, N304711485FE7, N30471153F8EC, N30471195347A, N30471199FE16, N3047120278B9, N304754069AA8, N30475435825B, N304754394837, N30475443AA65, N30475445CF53, N3047544814B6, N306144680873, N30614484580F, N306146006553, N3061460174DA, N306146024641, N3061460357C8, N3061460532FE, N3061461619BD, N30614661200A, N3061467139D2, N3061469380D0, N3061471314CC, N3061473453C3, N306147376158, N30614793DA0C, N30614795BF3A, N306148142AB4, N306148336DBB, N30614918BA04, N306149333767, N30614983D3CF, N306150028C23, N306150218D08, N288885978931, N28888599604F, N28888601D47B, N28888602E6E0, N28888605925F, N28888606A0C4, N288886095833, N28888611CDA3, N28888613EEB1, N28888617A895, N290848821182, N2908488657A6, N29084889AF51, N290848964E7E, N290848975FF7, N29084900A68C, N29118378D6CD, N29118379C744, N29118381C8C4, N29118382FA5F, N29118383EBD6, N291183849F69, N291183858EE0, N291183885505, N29118390C095, N29118391D11C, N29118392E387, N29118393F20E, N2911839486B1, N291183959738, N29118380D94D, N29118387ADF2, N29118396A5A3, N2874293301D1, N287429470AFD, N28742976311C, N290952904FCD, N290952915E44, N290952926CDF, N290952937D56, N2909529409E9, N290952951860, N290952962AFB, N290952973B72, N29095298C385, N29095299D20C, N29095300C209, N29095301D380, N29095302E11B, N29095303F092, N2909530595A4, N29095306A73F, N29095307B6B6, N290953084E41, N290953095FC8, N29095310DBD1, N29095311CA58, N29095312F8C3, N29095313E94A, N290953149DF5, N290953158C7C, N29095316BEE7, N290953185799, N290953194610, N29095320F1B9, N29095321E030, N29095322D2AB, N29095323C322, N29095324B79D, N29095325A614, N29095326948F, N290953278506, N290953287DF1, N290953296C78, N29095330E861, N29095331F9E8, N29095332CB73, N29095333DAFA, N29095334AE45, N29095335BFCC, N290953368D57, N290953379CDE, N290953386429, N2909533975A0; ***updated Jan 2024***N30471136FB91, N304711485FE7, N30471153F8EC, N30471195347A, N30471199FE16, N3047120278B9, N304754069AA8, N30475435825B, N304754394837, N30475443AA65, N30475445CF53, N3047544814B6, N306144680873, N30614484580F, N306146006553, N3061460174DA, N306146024641, N3061460357C8, N3061460532FE, N3061461619BD, N3061467139D2, N3061469380D0, N3061471314CC, N3061473453C3, N30614795BF3A, N306148142AB4, N306149333767, N30614983D3CF, N306150028C23, N306150218D08;
Risk classification
Class I
Area (FDA)
device
Country
United States

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