{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-09-17", "results": { "skip": 0, "limit": 1, "total": 6 } }, "results": [ { "cfres_id": "195438", "product_res_number": "Z-1654-2022", "event_date_initiated": "2022-08-26", "event_date_posted": "2022-09-09", "recall_status": "Open, Classified", "res_event_number": "90695", "product_code": "MNS", "k_numbers": [ "K113053" ], "product_description": "Philips BiPAP A30, Rx Only. To provide noninvasive ventilation support for patients with obstructive sleep apnea syndrome (OSA) and respiratory insufficiency.", "code_info": "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;", "firm_fei_number": "2518422", "recalling_firm": "Philips Respironics, Inc.", "address_1": "1001 Murry Ridge Ln", "city": "Murrysville", "state": "PA", "postal_code": "15668-8517", "additional_info_contact": "Philips Customer Service\n1-800-722-9377", "reason_for_recall": "Motor assemblies manufactured with nonconforming plastic that contributes to off-gassing of VOCs.", "root_cause_description": "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. \n\nCustomers 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. \n\nPhilips 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. \n\nCustomers with any questions are to contact Philips Respironics Recall Support at 1-877-387-3311 or email pms.fac@philips.com.", "product_quantity": "146 units ***updated January 2024*** 30 additional units", "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.\n\nForeign: 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.", "openfda": { "k_number": [ "K012323", "K070328", "K113714", "K171827", "K113288", "K252078", "K020777", "K090248", "K092043", "K033276", "K992530", "K942210", "K113815", "K112914", "K161487", "K063533", "K092818", "K090539", "K153061", "K132371", "K093070", "K231064", "K974417", "K123557", "K063540", "K093731", "K213169", "K031896", "K031656", "K102465", "K101130", "K240778", "K071509", "K984407", "K251661", "K051364", "K053168", "K111378", "K092186", "K161492", "K122324", "K962517", "K060546", "K251889", "K123511", "K060105", "K113053" ], "device_name": "Ventilator, Continuous, Non-Life-Supporting", "medical_specialty_description": "Anesthesiology", "regulation_number": "868.5895", "device_class": "2", "registration_number": [ "3002797442", "2518422", "3017684630", "3001400310", "3011120183", "3013505405", "3010817335", "9617566", "8040510", "3007421149", "3023322457", "3033526676", "3033530343", "3012428212", "9680721", "3004748541", "3038562397", "3023272766", "3013075752", "3009096682", "3007573469", "3000126629", "3029227324", "3008566132", "3018783526", "3007220521", "3011205710", "3013154126", "3004802249", "3012305175", "3004604967", "3026086583", "3042507287" ], "fei_number": [ "3003244771", "1000244733", "3002797442", "2518422", "3017684630", "3001400310", "3011120183", "3013505405", "3010817335", "3007421149", "3023322457", "3033526676", "3033530343", "3012428212", "3004748541", "3038562397", "3023272766", "3013075752", "3009096682", "1000115734", "3001319476", "3000126629", "3029227324", "3008566132", "3018783526", "3007220521", "3011205710", "3013154126", "3004802249", "3012305175", "3004604967", "3026086583", "3042507287" ] } } ] }