Philips Respironics, Inc.: Philips BiPAP A40, Rx Only. To provide noninvasive ventilation support for patients with obstructive sleep apnea syndrome (OSA) and respiratory insufficiency.

Recall number

Z-1655-2022

Recalling firm

Philips Respironics, Inc.

Product

Philips BiPAP A40, Rx Only. To provide noninvasive ventilation support for patients with obstructive sleep apnea syndrome (OSA) and respiratory insufficiency.

Status

Open, Classified

Initiated

2022-08-26

Posted

2022-09-09

Terminated

not on file

Reason

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

Root cause

Process control

Action

The firm distributed an "URGENT Medical Device Recall" letter to customers dated 8/26/2022 via mail. The notification informs customers that certain BiPAP V30 Auto and OmniLab Advanced+ units distributed in the US have the potential to off-gas harmful chemicals and structural failure of the device motor due to nonconforming material used in the assembly. Patients are to stop using the recalled devices and consult with their physician to determine the most appropriate options for continued treatment. Customers are asked to locate all affected devices and immediately stop use and remove them from service. Affected units are to be replaced by non-impacted units if it is being used by a patient. The provided recall notification needs to be distributed to all who must be aware within your organization or any organization where the units may have been transferred. Urgent Medical Device Response Forms provided must be completed and returned via email to pms.fac@philips.com. Philips is taking action by replacing the affected motor assemblies at the same time as they are remediating the PE-PUR Foam in recalled units. Philips will arrange for shipment of devices for repair and return. Customers with any questions are to contact Philips Respironics Recall Support at 1-877-387-3311 or email pms.fac@philips.com.

Quantity

1,091 units ***updated Jan 2024*** additional 323 units

Distribution

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, serial or model codes

UDI-DI: 606959042742, 606959042766, 606959042797, 606959067677, 606959067714, 606959042834, 606959067752, 606959067721, 606959068025; Model No.: 1109596, 1109598, 1109601, 1111169, 1111177, 1116153, 1116156, CN1111169, R1111177; Serial No.: V287427181CF7, V28772370BAC2, V28772449816E, V2877247036C7, V287782070507, V288703803DF5, V288703847BD1, V288703856A58, V2887038658C3, V28870387494A, V28870388B1BD, V28870389A034, V28870390242D, V2887039135A4, V28870392073F, V288703946209, V288703957380, V28870396411B, V288703975092, V28870398A865, V28870399B9EC, V288704007F30, V288704016EB9, V288704025C22, V288704043914, V28870405289D, V288704061A06, V288704070B8F, V28870408F378, V28870409E2F1, V2887041066E8, V288704117761, V2887041245FA, V288704135473, V288704171257, V28870418EAA0, V28870419FB29, V288704215D09, V288704226F92, V2887246677A0, V288724698F57, V28872472285C, V288724777FF1, V28872479968F, V288724808886, V28872485DF2B, V28872492B24C, V28872495C6F3, V288724981D16, V288725001C9A, 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V30423345AEC6, V304233478DD4, V30423351F13A, V30423361DB52, V304233648CFF, V304233684693, V30423370D303, V304234199617, V304234264488, V304234506CB6, V304234524FA4, V30428010A8A2, V30428100EBA6, V30428112D16C, V30428128545E, V30428174E08A, V30428188A92E, V3042820227D0, V304322297D59, V3043224386D3, V30432250AD90, V3043228891A0, V304322988878, V30432303BB6F, V30432340EE94, V304323468BA2, V30432350F74C, V30432353C5D7, V304324331D02, V30432438A3D1, V30432443500A, V304324859C9C, V30432497A656, V304325005F2D, V304325235E06, V304325307545, V3043253701FA, V30432593BAAE, V30432602935B, V30432607C4F6, V304326494AE8, V30432653FC6A, V30432657BA4E, V30432698EB19, V30432700EA95, V304327068FA3, V30432723EBBE, V3043272944E4, V30432730C0FD, V30432752B73F, V30432775F030, V3043279658BB, V30432842E420, V30432846A204, V30432851CF63, V3043287799E5, V3043289166C3, V3043289703F5, V304329197E97, V304329248F1A, V30432935874B, V30432944DBCA, V30432955D39B, V3043295919F7, V304329628D4C, V304330401D4B, V304330454AE6, V304330489103, V30433081A562, V304330838670, V3043308838A3, V304331267671, V304331333804, V3043313886D7, V304331404797, V3043316346BC, V304331742BDB, V304331753A52, V304331978350, V30437205EAD2, V304372280287, V30437233A58C, V30437236F221, V304372381B5F, V304372390AD6, V30437240DA1F, V30440538F0A7, V30440579864E, V304405919016, V304406029AF1, V3044074195D6, V304407509D87, V30440757E938, V30440771BFBE, V304409168FCA, V30440921D11D, V30440937ADF3, V30440944D260, V30441119AD44, V30441129872C, V304411462B0B, V30441159CA24, V30443352F839, V304433687D0B, V304433842D77, V304434031B0D, V30443642D85C, V30443740A192, V30443744E7B6, V30443747D52D, V304440111587, V3044402579CB, V3044414754D5, V2909534134BE, V290953503CEF, V29095358B0A7, V305001089095, ***update January 2024 *** V304755366A42, V30475549DFBD, V304755541D80, V30475558D7EC, V30475666FB9E, V3047566812E0, V304756780B38, V30475684429C, V3047568888F0, V30475772FEBE, V3047577851E4, V304757836CFF, V30475835A7A6, 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V30414056200C, V30414257843D, V30414725D39A, V30419201143C, V304885482F47, V30488578052F, V304885945553, V304886404C6B, V304886440A4F, V304886625CC9, V3048870071D7, V304887124B1D, V30488718E447, V304887341D9B, V304887476208, V304896734823, V304896743C9C, V304896761F8E, V304896770E07, V30489682DA62, V30489685AEDD, V304896869C46, V30489692C3BA, V30489693D233, V30489694A68C, V30489695B705, V3048971257A6, V30489713462F, V304897152319, V30489717000B, V304897236C47, V3048972418F8, V304897263BEA, V304897272A63, V30489733759F, V304897340120, V3048973510A9, V304897362232, V30489742291E, V304897433897, V304897444C28, V304897466F3A, V3048975013D4, V3048975230C6, V30489753214F, V304897554479, V3048976039BC, V304897647F98, V304897656E11, V304897665C8A, V304897746640, V304897764552, V3048977754DB, V30489778AC2C, V30489795EDD9, V3049382485D5, V30493892044B, V30493962DD5F, V304940603572, V304940647356, V3049406562DF, V30494113103D, V304941277C71, V304941617E27, V3049417521DB, V30495245F86C, V3049543740AF, V30495438B858, V30495448F550, V30495459FD01, V304954705370, V3049554200D6, V30495559A7DD, V304955711825, V30495615E5B5, V30495616D72E, V30495617C6A7, V30495643FE3B, V304956817489, V30495698F090, V30495714AEE0, V3049942836B4, V30499482649E, V30499498D21C, V30499512E95A, V304997532A0B, V304997674647, V304997839A73, V305000172B66, V305001023FCF, V30500113379E, V305002738C2A, V3050031293AF, V30500323A84E, V3050057211A6, V3050058383E7, V30500605C775, V30500850FE7B, V30500863E688, V3050089411FF, V305010633CF1, V305010666B5C, V3050108909BB, V30501370F8D6, V305013861E28, V305014012852, V30501418AC4B, V30558986B265, V30558991DF02, V30560798AACC, V305608458B96, V305609079538, V30560970AC8F, V30561911F56D, V305620037674, V3056207885AF, V30562127593C, V305621443F77, V30562236BE09, V3057238539A2, V30572393454C, V30572459CFB3, V305724886E42, V305725043032, V30572519F20F, V30572529D867, V305725467440, V30572584FEF2, V30572607EDCD, V305726579375, V30572677A0C5, V30572710DA76, V30572721E197, V3057278779D1, V3057280198E0, V305728283691, V30572940B4D5, V30572941A55C, V3057294297C7, V30572943864E, V30572944F2F1, V30572945E378, V30572946D1E3, V30572947C06A, V30572957D9B2, V305730005310, V305730260596, V30573049A9B1, V305730818C59, V305730919581, V30573092A71A, V30581373906D, V30581382022C, V305813947EC2, V3058140425DF, V305814107A23, V3058142362D0, V305814340FB7, V305814362CA5, V305814545B67, V3058146126A2, V3058147468D7, V305815175440, V305815244CB3, V3058153544E2, V305815427D55, V305815515616, V3058155401BB, V305815635F6C, V305815770090, V305815896A26, V30581595B992, V30581607A2FC, V30581627914C, V305816528BE9, V305816709B4B, V30581681090A, V3058173285E5, V30581745BC52, V30581761C9C6, V30581822D6FA, V30581823C773, V30581824B3CC, V30581825A245, V3058182879A0, V30581837988F, V30581844E71C, V30581863A013, V305818681EC0, V30581874CD74, V305818855F35, V305818945764, V30581952C12E, V30581954A418, V30581963FACF, V30581967BCEB, V305819758621, V305819863772, V305819915A15, V305819962EAA, V3058202450C3, V305820311EB6, V3058203992FE, V305820505BEF, V30582063431C, V3058207179D6, V305821251B96, V30582131446A, V3058213630D5, V305821445ECF, V30582171230A, V30582186D47D, V3058325697DA, V3058328404B0, V305832851539, V3058328627A2, V30583287362B, V30583288CEDC, V305832905B4C, V305832941D68, V30583302F59A, V3058331598FD, V305833286970, V30583335AB4D, V30583345E645, V30583364C47C, V305833922282, V305834041CA9, V3058341514F8, V305834260C0B, V3058343615D3, V305834474952, V305834600E5D, V305834688215, V3058347672B3, V30583532092B, V305835442115, V3058355438CD, V305836178252, V305836196B2C, V30583622FF97, V305836258B28, V305836491594, V305837139EAA;

510(k) numbers

["K090248"]

PMA numbers

not on file

Product code

MNS

Firm FEI

2518422

Firm city

Murrysville

Firm state

PA

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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