{ "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": "2026-09-05", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "175422", "product_res_number": "Z-2553-2019", "event_date_initiated": "2019-08-01", "event_date_created": "2019-09-23", "recall_status": "Open, Classified", "res_event_number": "83491", "product_code": "DSA", "k_numbers": [ "K080112" ], "product_description": "Gold Cup Leadwire and Snap Leadwire with the following component descriptions: \n\n1. 24\" Snap Leadwire, Blue; \n\n2. 40\" Snap Leadwire, Blue; \n\n3. 24\" Snap Leadwire, Red; \n\n4. 40\" Snap Leadwire, Red; \n\n5. 24\" Snap Leadwire, Green; \n\n6. 40\" Snap Leadwire, Green; \n\n7. 24\" Snap Leadwire, Brown; \n\n8. 40\" Snap Leadwire, Brown; \n\n9. 24\" Snap Leadwire, Orange; \n\n10. 40\" Snap Leadwire, Orange; \n\n11. 24\" Snap Leadwire, White; \n\n12. 40\" Snap Leadwire, White; \n\n13. 24\" Snap Leadwire, Black; \n\n14. 40\" Snap Leadwire, Black; \n\n15. 24\" Snap Leadwire, Yellow; \n\n16. 40\" Snap Leadwire, Yellow; \n\n17. 24\" Snap Leadwire, Set of 5; \n\n18. 24\" Snap Leadwire, Set of 7; \n\n19. 40\" Snap Leadwire, Set of 5; \n\n20. 40\" Snap Leadwire, Set of 7; \n\n21. 24\" Snap Leadwire, Set of 5; \n\n22. 40\" Snap Leadwire, Set of 5; \n\n23. 48\" Gold Cup Leadwires, Blue; \n\n24. 48\" Gold Cup Leadwires, Red; \n\n25. 48\" Gold Cup Leadwires, Green; \n\n26. 48\" Gold Cup Leadwires, Brown; \n\n27. 48\" Gold Cup Leadwires, Orange; \n\n28. 48\" Gold Cup Leadwires, White; \n\n29. 48\" Gold Cup Leadwires, Black; \n\n30. 48\" Gold Cup Leadwires, Yellow; \n\n31. 48\" Gold Cup Leadwires, Set of 5; \n\n32. 48\" Gold Cup Leadwires, Set of 8; \n\nProduct Usage: The snap electrode leads are used in conjunction with disposable electrodes and the Gold Cup electrodes are reusable electrodes and leads. Both types of electrodes and leads are used for evoked potential testing for audiological, neurological and/or vestibular testing. The electrode leads are connected to the main device by the electrode lead connector and the electrode is attached to the patient contact end of electrode lead.", "code_info": "Part Numbers:   1. 7590310-24;   2. 7590310-40;   3. 7590311-24;   4. 7590311-40;   5. 7590312-24;   6. 7590312-40;   7. 7590313-24;   8. 7590313-40;   9. 7590314-24;   10. 7590314-40;   11. 7590315-24;   12. 7590315-40;   13. 7590316-24;   14. 7590316-40;   15. 7590317-24;   16. 7590317-40;   17. 7590318-24-5;   18. 7590318-24-7;   19. 7590318-40-5;   20. 7590318-40-7;   21. 7590319-24-5;   22. 7590319-40-5;   23. 7590440;   24. 7590441;   25. 7590442;   26. 7590443;   27. 7590444;   28. 7590445;   29. 7590446;   30. 7590447;   31. 7590450-5;   32. 7590450-8", "firm_fei_number": "3002807554", "recalling_firm": "GN Otometrics", "address_1": "Horskatten 9 9 horskatten", "city": "Taastrup", "country": "Denmark", "reason_for_recall": "The electrode lead connector has a protruding conductor beyond insulation of approximately 0.1 mm.", "root_cause_description": "Software design (manufacturing process)", "action": "GN Otometrics notified customers on about 08/01/2019 via \"URGENT FIELD SAFETY NOTICE (FSN) MEDICAL DEVICE RECALL\" letter. The notification informed customers that the electrode lead connector has a protruding conductor beyond insulation of approximately 0.1 mm and there is potential risk to healthcare professionals or patients of exposure to electrical shock form the electrode connector. \n\nInstructions included to identify, cease use and quarantine the affected electrode leads, ensure all personnel are notified who need to be aware, notify customers if the affected electrode leads have been further distributed, and arrange for the return of affected electrode leads to Natus Medical, 3150 Pleasant View Lane, Middleton, WI 53562. Customers were also instructed to complete and return the Customer Reply Form via email to otochartrLeads.US@natus.com or fax to 1-847-557-1308.", "product_quantity": "4,882 units (41950 individual electrode leads supplied In 5,7 & 10 packs)", "distribution_pattern": "Worldwide distribution - US Nationwide in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, and countries of Argentina, Australia, Austria, Azerbaijan, Bahrain, Belgium, Brazil, Canada, Chile, China, Colombia, Cote D'ivoire, Croatia, Czech Republic, Denmark, Ecuador, Egypt, El Salvador, Estonia, France, Germany, Greece, Guyana, Hong Kong, Hungary, India, Indonesia, Iran (Islamic Republic of), Iraq, Ireland, Israel, Italy, Jordan, Kazakhstan, Korea, Korea, Republic of, Kuwait, Lebanon, Luxembourg, Macedonia, The Former Yugoslav, Malaysia, Maldives, Mayotte, Mexico, Morocco, Myanmar, Netherlands, New Zealand, Norway, Oman, Pakistan, Panama, Peru, Philippines, Poland, Portugal, Qatar, Romania, Russia, Saudi Arabia, Serbia, Singapore, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Thailand, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Viet Nam, Zimbabwe.", "openfda": { "k_number": [ "K800931", "K172797", "K801064", "K152947", "K200674", "K240087", "K220447", "K240156", "K082959", "K982817", "K093657", "K770884", "K254114", "K191428", "K222712", "K885101", "K062577", "K952659", "K940302", "K932704", "K922899", "K251669", "K093858", "K980582", "K882174", "K190078", "K771027", "K001390", "K200510", "K201359", "K230571", "K980806", "K880320", "K971968", "K172591", "K191273", "K022075", "K802236", "K801041", "K885137", "K182220", "K080112", "K942321", "K222370", "K203635", "K960446", "K170536", "K873492", "K240377", "K162432", "K012392", "K984263", "K800932", "K132253", "K023334", "K101660", "K181089", 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"3016678045", "3009773371", "1721676", "3017953522", "3000279201", "3036754877", "3017619536", "3001104093", "3004415095", "3002807391", "3019388613", "1000121056", "3013300026", "3003263092", "3003076831", "3010705768", "3015286931", "3000210521", "2939520", "3013596024", "3003971136", "2011171", "3002615969", "3003513129", "3002893037" ], "device_name": "Cable, Transducer And Electrode, Patient, (Including Connector)", "medical_specialty_description": "Cardiovascular", "regulation_number": "870.2900", "device_class": "2" } } ] }