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

Hazard

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

Details from the source

Reason for recall: Motor assemblies manufactured with nonconforming plastic that contributes to off-gassing of VOCs. 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, Quantity: 1,091 units ***updated Jan 2024*** additional 323 units Lot/code info: 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, V288725010D13, V288725023F88, V288725032E01, V288725045ABE, V288725054B37, V288725100542, V2887251114CB, V288725122650, V2887251771FD, V28872518890A, V288725199883, V288725257887, V288725275B95, V28872528A362, V28872529B2EB, V2887253036F2, V28872531277B, V2887253215E0, V288725330469, V2887253470D6, V28872535615F, V2887253653C4, V28872537424D, V28872538BABA, V28872539AB33, V288725407BFA, V288725416A73, V2887254258E8, V288725434961, V288725452C57, V288725461ECC, V288725470F45, V28872548F7B2, V28872549E63B,

UPC codes

606959042742, 606959042766, 606959042797, 606959067677, 606959067714, 606959042834, 606959067752, 606959067721, 606959068025

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.