{ "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": "121946", "product_res_number": "Z-0112-2014", "event_date_initiated": "2013-07-31", "event_date_posted": "2013-10-30", "recall_status": "Terminated", "event_date_terminated": "2014-03-04", "res_event_number": "66144", "product_code": "FDS", "k_numbers": [ "K120446" ], "product_description": "Fujinon/Fujifilm Ultrasonic Endoscope\n\nIntended to provide ultrasonic images of submucosal and peripheral organs of the upper gastrointestinal tract for observation, diagnosis and endoscopic treatment.", "code_info": "Model Number EG-530UT2. Serial Numbers: NU038A018, NU038A019, NU038A022, NU038A027, NU038A028 and NU038A029", "firm_fei_number": "2431293", "recalling_firm": "Fujinon Inc", "address_1": "10 Highpoint Dr", "city": "Wayne", "state": "NJ", "postal_code": "07470", "additional_info_contact": "Ms. Gina Walljasper\n973-686-2636", "reason_for_recall": "A limited number of endoscopes were shipped to FMSU-ESD with a manufacturing defect which included missing set screws used to more securely attach the Forceps Inlet (biopsy inlet port) to the endoscope.", "root_cause_description": "Unknown/Undetermined by firm", "action": "The firm, FUJIFILM Medical Systems, USA, Inc. (FMSU-ESD) sent an \"URGENT-MEDICAL DEVICE CORRECTION (UMDC)\" and Customer Acknowledgement forms dated July 31, 2013 to their customers. The letter described the issue with the affected product; instructed customers on how to identify affected units; instructed customers to immediately cease use of the affected units; return affected units to FMSU-ESD for repairs and quality control inspection; and complete and return the attached \"Customers Acknowledgement\" form to FMSU-ESD, Attn: Regulatory Compliance, via fax to (973) 686-2616 or email: gwalljasper@fujifilm.com.\n\nIf you have any questions regarding this notice, please do not hesitate to contact Director, Quality and Regulatory Compliance, at (973) 686-2636 or by email: gwalljasper@fujifilm.com.", "product_quantity": "12 Units", "distribution_pattern": "Worldwide distribution: US (nationwide) including states of: NJ, PA and VA; and country of Canada.", "openfda": { "k_number": [ "K241213", "K232997", "K021886", "K162749", "K250296", "K250550", "K011151", "K111243", "K142629", "K833924", "K193123", "K180341", "K153206", "K181763", "K200850", "K253568", "K243512", "K242779", "K971660", "K961564", "K212382", "K974493", "K251256", "K943715", "K013640", "K832007", "K210162", "K140295", "K251041", "K971734", "K850020", "K212296", "K032177", "K240142", "K180911", "K250900", "K060907", "K232314", "K131422", "K984358", "K232919", "K173004", "K251708", "K093779", "K123317", "K210915", "K002231", "K113166", "K001766", "K933717", "K182836", "K172916", "K210485", "K232028", "K063847", "K120446", "K253702", "K131902", "K180292", "K152182", "K210177", "K221551", "K962460", "K130148", "K242635", "K962897", "K183686", "K243388", "K213606", "K963023", "K192704", "K260573", "K190799", "K042043", "K183572", "K063316" ], "device_name": "Gastroscope And Accessories, Flexible/Rigid", "medical_specialty_description": "Gastroenterology, Urology", "regulation_number": "876.1500", "device_class": "2", "registration_number": [ "", "1528319", "3010141954", "3002808148", "3009698186", "3015131155", "3017140456", "3010703925", "3013944123", "3015136743", "3015807001", "9611680", "3012494290", "3015223550", "3010188783", "3013023255", "3010390468", "3010220595", "9617070", "3010202439", "3021246306", "1450997", "2183744", "3004111573", "3042225166", "3042172882", "8010047", "3008627763", "3005099803", "3013440400", "3009171251", "3024021261", "3010288205", "3014605202", "3004040397", "3004644065", "9610691", "9610877", "3003775006", "3004837686", "3006161756", "3008797804", "2020550", "3003782610", "3011416394", "1221826", "3015525240", "3014769442", "3011050570", "3013247477", "3008386005", "3002807310", "3021691063", "3015746529", "9611112", "9610617", "3015451828", "3015194986", "3012843412", "9614641", "3043226252", "3010707607", "9610595", "3004705634", "3014342096", "3003790304", "3018258446", "3011816755", "1649518" ], "fei_number": [ "", "3010141954", "3002808148", "3009698186", "3015131155", "3017140456", "1000122656", "3010703925", "3015136743", "3013944123", "3015807001", "3012494290", "3002807134", "3015223550", "3001236277", "3010188783", "3013023255", "3010390468", "3008185830", "3002807795", "3010220595", "3042225166", "3042172882", "3007475226", "3021246306", "2183744", "3004111573", "1450997", "3008627763", "3005099803", "3013440400", "3024021261", "3010288205", "3003995201", "3014605202", "3004040397", "3004644065", "3003775006", "3004837686", "3002807969", "3002806359", "3008797804", "2020550", "3003782610", "3011416394", "1221826", "3006759904", "3008782585", "3015525240", "3014769442", "3011050570", "3013247477", "3008386005", "3002807310", "3021691063", "3002808127", "3015746529", "3015451828", "3015194986", "3012843412", "3002964398", "3043226252", "3010707607", "3014342096", "3004705634", "3002808268", "3003790304", "3011816755", "3018258446" ] } } ] }