{ "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": "2026-08-15", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "175004", "product_res_number": "Z-0170-2020", "event_date_initiated": "2019-05-28", "event_date_created": "2019-10-23", "recall_status": "Terminated", "event_date_terminated": "2021-04-09", "res_event_number": "83380", "product_code": "GWJ", "k_numbers": [ "K083399" ], "product_description": "The ICS CHARTR EP 200", "code_info": "Part No.\t Description\t UDI of the Device 8-04-12733\tICS Chartr EP 200 2Ch, TDH49 , 115/60\t05713315006449;  8-04-12734\tICS Chartr EP 200 2Ch,Insert&Bone\t 05713315006173;  8-04-12731\tICS Chartr EP 200 2ch, 230 VAC (50 Hz) Incl. Insert Earphone; TDH49 Earhone w cable, Bone Conduction Transducer (B71), VEMP Monitor Kit and ASSR\t 05713315006432;  8-04-12730\tICS Chartr EP 200 2ch, 230 VAC (50 Hz) Incl. Insert Earphone; TDH49 Earhone w cable, Bone Conduction Transducer (B71) and ASSR\t  05713315006425; 8-04-12729\tICS Chartr EP 200 2Ch, 230 VAC (50 Hz) Incl. Insert Earphone, Bone Conduction Transducer (B71) and VEMP Monitor Kit\t05713315006388;  8-04-12727\tICS Chartr EP 200 2Ch, 230 VAC (50 Hz) Incl. Insert Earphone, TDH49 Earhone w cable and VEMP Monitor Kit\t 05713315006418; 8-04-12725\tICS Chartr EP 200 2ch, 230 VAC (50 Hz) Incl. Insert Earphone, TDH49 Earhone w cable, Bone Conduction Transducer (B71), VEMP Monitor Kit, P300 and ASSR\t 05713315006395;  8-04-12723\tICS Chartr EP 200 2ch. 230 VAC (50 Hz) Incl. Insert Earphone, TDH49 Earhone w cable\t 05713315006401; 8-04-12721\tICS Chartr EP 200 2ch. 230 VAC (50 Hz) Incl. Insert Earphone\t  05713315006371; 8-04-12720\tICS Chartr EP 200 2ch. 230 VAC (50 Hz) Incl. Insert Earphone, TDH49 Earhone w cable, Bone Conduction Transducer (B71) and EU power cord.\t 05713315007996; 8-04-12711\t1073 ICS Chartr EP 200 w/o Vemp, CN only\t N/A; 8-04-12710 1073 ICS Chartr EP 200, CN only\t N/A; 8-04-12703\t1073 ICS Chartr EP 200 Insert, Bone & TDH49 2Ch, US only\t 05713315002724; 8-04-12702\t1073 ICS Chartr EP 200 Insert, Bone 2 Ch, US only\t 05713315002717; 8-04-12701\t1073 ICS Chartr EP 200 ROW 2 Ch.\t N/A; 8-04-12700\t1073 ICS Chartr EP 200 Insert 2 Ch, US Only 05713315002700; 8-04-12732\tICS Chartr EP 200 Limited, 1 ch, TDH49, 115/60 05713315006364; 8-04-12728\tICS Chartr EP 200 Limited, 1 ch Insert, Bone, TDH49 & VEMP Monitor Kit\t 05713315006333; 8-04-12726\tICS Chartr EP 200 Limited, 1 ch, TDH49 05713315006357; 8-04-12724\tICS Chartr EP 200 Limited, 1 ch Insert & TDH49 05713315006340;  8-04-12722\tICS Chartr EP 200 Limited, 1 ch, Insert\t 05713315006326; 8-04-12712\t1073 Chartr EP 200 Limited, China\t N/A; and  8-04-12704\t1073 Chartr EP 200 Limited\t 05713315003226", "firm_fei_number": "3002807554", "recalling_firm": "GN Otometrics", "address_1": "Horskatten 9 9 horskatten", "city": "Taastrup", "country": "Denmark", "reason_for_recall": "There is a risk to the healthcare professional or patient of exposure to undergrounded electrical surfaces which may result in an electrical shock.", "root_cause_description": "Device Design", "action": "On May 2019 Otometrics a division of Natus sent letter to the consignees with the following instructions: \nGeneral Information\n\nFSN Type: Recall\n\nNatus will be removing all affected products from the market.\n\nFurther information or advice\nWhile there have not been any reported safety incidences, our commitment to providing only the highest quality products and information to our customers and distribution partners is our top priority, and we sincerely apologize for any inconvenience this will cause. If there are any questions about this notice, please contact your authorized Natus distributor.\n\nThis notice needs to be passed on to all those who need to be aware within your organization or to any organization where the potentially affected devices have been transferred. (As appropriate)\n\nPlease transfer this notice to other organizations on which this action has an impact. (As appropriate)\n\nPlease maintain awareness on this notice and resulting action for an appropriate period to ensure effectiveness of the corrective action.\n\nPlease report all device-related incidents to the manufacturer, distributor or local representative, and the national Competent Authority if appropriate, as this provides important feedback\n\nEU customers only: The Competent (Regulatory) Authority of your country has been informed about this communication to customers.\n\nAttached\nInstructions for device return\nCustomer Reply Form\nList of affected part numbers\nINSTRUCTIONS FOR DEVICE RETURN\n\n\nWe kindly ask that you initiate the following activities immediately:\n\n1.\tIdentify and quarantine the affected devices. Cease use of all affected devices immediately.\n2.\tReview this communication in its entirety and ensure that all users of the listed products in your organization are informed of this notification.\n3.\tDistribute this notification to all associated parties within your organization.\n4.\tComplete and return the Verification Form enclosed in this letter via e-mail o", "product_quantity": "3071 individual units", "distribution_pattern": "AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, WA, WI, and WV\nArgentina, Australia, Austria, Azerbaijan, Bahrain, Belgium, Brazil, Canada, Chile, China, Colombia, Cote D'ivoire, Croatia, Czech Republic, Czech Republic, Denmark, Ecuador, Egypt, El Salvador, Estonia, Finland, France, Georgia, Germany, Greece, Guyana, Hong Kong, Hungary, India, \nIran (Islamic Republic of), Iraq, Ireland, Israel, Italy, Jordan, Kazakhstan, Korea, Republic of, Kuwait, Lebanon, Luxembourg, Malaysia, Maldives, Mayotte, Mexico, Morocco, Morocco, Netherlands, Netherlands, New Zealand, Norway,\nOman, Panama, Peru, Philippines, Poland, Portugal, Qatar, Romania, Russia, \nSaudi Arabia, Serbia, Singapore, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, \nViet Nam, and Zimbabwe", "openfda": { "k_number": [ "K082035", "K021895", "K993177", "K992807", "K030907", "K031009", "K011746", "K862361", "K905632", "K090579", "K770268", "K810473", "K913957", "K852687", "K925648", "K822177", "K830579", "K936039", "K002985", "K073665", "K913785", "K012415", "K813009", "K770878", "K143670", "K011842", "K013137", "K862430", "K083399", "K111555", "K132957", "K904926", "K832510", "K994149", "K862906", "K863985", "K792085", "K781667", "K031051", "K953732", "K070696", "K233649", "K810138", "K122067", "K013977", "K211147", "K021215", "K100661", "K103760", "K070608", "K242954", "K193033", "K043396", "K141446", "K220139", "K810539", "K061443", "K874193", "K073626", "K163326", "K162037", "K131141", "K991853", "K092373", "K960097", "K972157", "K870030", "K926574", "K863156", "K952080", "K073384", "K862363", "K780540", "K123701", "K080060", "K030823" ], "registration_number": [ "9612197", "3005877899", "3006418479", "3012182497", "1650946", "3002504821", "3007048291", "3008881376", "3004046843", "3005581270", "9610105", "3016438694", "3013500228", "3018094310", "3034880867", "9710051", "3008857629", "3004920696", "9611252", "3011310592", "2184161", "3009973505", "3015781813", "3013501110", "3020018", "3007962724", "3008729547", "1052723", "3011184129", "3008483389", "3016852448", "9612330", "3008111228", "3013679558", "3003851073", "3010900508", "3006177498", "3001687738", "3008657524", "2023374", "8030229", "3010536822", "2113281", "3008773490", "3038189172", "2080783", "1651104", "3004753785", "1045254", "9710602", "3000279201", "3013596024", "3010611950", "3011766844", "3009649442", "8021990", "9613619" ], "fei_number": [ "3005877899", "3006418479", "3012182497", "3002504821", "3007048291", "3008881376", "3004046843", "3005581270", "3016438694", "3013500228", "3018094310", "3034880867", "3002807554", "3004920696", "3008857629", "3011310592", "3009973505", "3015781813", "3013501110", "3002807739", "3020018", "3002807720", "1000113738", "3007962724", "3008729547", "1000139867", "3008483389", "3011184129", "3016852448", "3008111228", "3013679558", "2939", "3003851073", "3004674371", "3010900508", "3006177498", "3001687738", "3000254565", "3008657524", "2023374", "2113281", "3010536822", "3008773490", "3003513129", "3038189172", "2080783", "3002737156", "3004753785", "3002716534", "1045254", "3000279201", "3002806783", "3013596024", "3002809369", "3010611950", "3011766844", "3009649442" ], "device_name": "Stimulator, Auditory, Evoked Response", "medical_specialty_description": "Neurology", "regulation_number": "882.1900", "device_class": "2" } } ] }