{ "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": "185666", "product_res_number": "Z-1162-2021", "event_date_initiated": "2021-01-08", "event_date_created": "2021-03-02", "recall_status": "Open, Classified", "res_event_number": "87264", "product_code": "DRG", "k_numbers": [ "K071058" ], "product_description": "WMTS Telemetry Receiver, Multiple Patient Receiver, Model Number/ UDI:\nORG 9100A/ 00841983102554\nORG 9110A/ 00841983102561\nORG 9700A/No UDI", "code_info": "ORG 9100A serial numbers: 00001 to 01413 ORG 9110A serial numbers: 00001 to 02706  ORG 9700A serial numbers: 00001 to 00894", "firm_fei_number": "2080783", "recalling_firm": "Nihon Kohden America Inc", "address_1": "90 Icon", "city": "Foothill Ranch", "state": "CA", "postal_code": "92610-3000", "additional_info_contact": "Nihon Kohden America Technical Services Group\n949-580-1555", "reason_for_recall": "Incorrect Date Stamp or No Data Transfer on Telemetry Receiver and Transmitter.", "root_cause_description": "Software design", "action": "An URGENT RECALL NOTIFICATION was sent to the consignees via FedEx on 01/27/2021.\nRecall Instructions\n1.\tPlease notify all individuals that need to be made aware of this issue/recall, and that the recall notification should be posted with the affected products.\n2.\tComplete the attached form and return to Nihon Kohden America.\n3.\tIf adverse reactions or quality problems are experienced with the use of this product, please report to the FDAs MedWatch Adverse Event Reporting program either online, by regular mail, or by fax.\n\"\tOnline: www.f da.gov/medwatch/report.htm\n\"\tMail: Download form www.fda.gov/medwatch/getforms.htm or call 1-800-332-1088 to request a report form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178.\n4. If adverse reactions or quality problems are experienced with the use of this product, please report the event to Nihon Kohden Technical Support at: 1-800-325-0283 or email ORG@nihonkohden.com.\n\nIssue Resolution\nNihon Kohden America plans to release a new software version for the ORG-9100A / ORG 9110A.\n\nThe ORG-9700A has the same issues but has been discontinued by the manufacturer and is no longer supported. Please contact your Nihon Kohden America Account Executive.", "product_quantity": "4,436", "distribution_pattern": "US - AL, AZ, AR, CA, CO, CT, DE, DC, FL, GA, HI, ID, IL, IN, IA, KS,KY, LA, ME, MA, MD, MI, MS, MS, MO, NE, NV, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, SC, TN, TX, UT, VA, VT, WA WI, WV and WY.", "openfda": { "k_number": [ "K945037", "K904748", "K071564", "K163694", "K103643", "K090801", "K100524", "K130290", "K090610", "K072698", "K091696", "K172011", "K081499", "K023749", "K120704", "K103796", "K790109", "K181196", "K061606", "K223711", "K202868", "K200690", "K100508", "K124000", "K191620", "K141167", "K030795", "K134004", "K791363", "K242018", "K940009", "K101242", "K071953", "K821384", "K133252", "K252984", "K212883", "K112858", "K823906", "K030222", "K061502", "K802273", "K113446", "K170204", "K191614", "K163453", "K052961", "K910620", "K914889", "K113493", "K973873", "K252440", "K974149", "K243837", "K111854", "K120470", "K100427", "K172329", "K161916", "K073710", 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"medical_specialty_description": "Cardiovascular", "regulation_number": "870.2910", "device_class": "2" } } ] }