{ "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": "2026-08-13", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "203832", "product_res_number": "Z-0403-2024", "event_date_initiated": "2023-09-26", "event_date_posted": "2023-11-25", "recall_status": "Open, Classified", "res_event_number": "93275", "product_code": "EWO", "k_numbers": [ "K133012", "K213345" ], "product_description": "AuDX PRO, mobile medical devices for hearing examinations, Model Number SOH100098, Part Number 100098-AUP", "code_info": "UDI-DI: 04260223143298;\n\nSerial Numbers: 260446-260468", "firm_fei_number": "3008111228", "recalling_firm": "PATH", "address_1": "Landsberger Str. 65 65 landsberger str.", "city": "Germering", "country": "Germany", "additional_info_contact": "Diane Sabo, PhD\n+498980076502", "reason_for_recall": "Affected lots of product may experience technical distortions to a greater extent than expected.", "root_cause_description": "Process change control", "action": "An URGENT: MEDICAL DEVICE RECALL SENTIERO notification letter dated 9/26/23 was sent to customers.\n\nActions to be taken by the User:\nThe technical distortions can influence the specified performance of the device when performing diagnostic DPOAEs at high stimuli. Therefore, PATH MEDICAL chose to voluntarily recall affected products for correction.\n1.\nImmediately identify any affected devices at your location and quarantine them.\n2.\nPlease return your affected device(s) to your local distributor or PATH MEDICAL directly (Shipping Address: Landsberger Str. 65, 82110 Germering, Germany) to have your PCB replaced. Upon request, return labels can be provided.\n3.\nIf the device(s) have been further distributed to other accounts, please forward this notice to them to inform them of the recall.\n4.\nReport any adverse events to FDA MedWatch: Use the MedWatch Online Reporting Form or call 800-332-1088.\nRe-Screening of patients screened with a device subject to the recall is not necessary, as regular DPAOE screening would not be done at stimuli as high as they would be affected by the issue. Furthermore, DPOAE-based hearing screening always consists of measurements at multiple frequencies. Therefore, false positive DPOAE detections at a single frequency, which are already considered unlikely, would not necessarily falsify the overall screening result (e.g., pass criterion 3 out of 4).\nPlease be aware that your local competent authority may have been informed of this recall, if required by law.\nThank you for your cooperation.\nIn case there are additional questions, please contact us under:\nMail: qm@pathme.de\nPhone: +49 (0)89 80076502", "product_quantity": "23 units", "distribution_pattern": "US States: FL, MO, OH, WI", "openfda": { "k_number": [ "K854534", "K780382", "K844069", "K950888", "K791467", "K841567", "K970279", "K981460", "K935348", "K915323", "K033108", "K052562", "K060539", "K890842", "K053216", "K895200", "K921085", "K770553", "K854835", "K953884", "K904544", "K001058", "K121512", "K981439", "K070118", "K904270", "K883478", "K090406", "K802207", "K863979", "K874516", "K953814", "K981327", "K902540", "K862592", "K964426", "K943065", "K983350", "K964132", 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"K922383", "K895310", "K933220", "K060883", "K760859", "K914232", "K770823", "K951527", "K092111", "K953684", "K980533", "K833883", "K895784", "K790878" ], "registration_number": [ "1220135", "3030896102", "3014343954", "3041276591", "3012494290", "2113281", "3008881376", "3014579161", "3043139378", "3020869111", "3015246392", "3020796592", "3014656175", "3032870", "3017644066", "3029060079", "2011951", "3005053770", "3014337591", "8021990", "3002821232", "3043496923", "3034880867", "3005785669", "3004046843", "9611864", "3008717264", "3027357482", "1052723", "3010539401", "3031700059", "3008111228", "1316463", "3012213704", "3010419931", "3043885029", "3008699634", "3002504821", "3012302888", "3013557562", "3030447506", "3000279201", "3011359729", "3011310592", "9710051", "9612197", "3026566521", "3005019184", "3008386587", "3030089857", "3019918054", "3005581270", "3013598036", "3013333417", "1058264", "1450042", "3013596041", "3003138182", "3006418479", "3004052117", "3007307502", 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"regulation_number": "874.1050", "device_class": "2" } } ] }