{ "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": "203683", "product_res_number": "Z-0056-2025", "event_date_initiated": "2023-09-14", "event_date_posted": "2024-10-11", "recall_status": "Open, Classified", "res_event_number": "93217", "product_code": "FDF", "k_numbers": [ "K131780" ], "product_description": "EVIS EXERA III Video System Center Model Number CV-190. Intended to be used with OLYMPUS camera heads, endoscopes, light sources, monitors, EndoTherapy accessories, and other ancillary equipment for endoscopic diagnosis, treatment, and video observation", "code_info": "UDI-DI: 04953170298622;\nSerial Numbers: \n7384484\n7384422\n7384487\n7384478\n7384479\n7384442\n7384441\n7384485\n7384451\n7384455\n7384481\n7384470\n7384424\n7384423\n7384489\n7384531\n7384516\n7384492\n7384512\n7384543\n7384483\n7384624\n7384623\n7384497\n7384495\n7384494\n7384533\n7384622\n7384660\n7384654\n7384656\n7384647\n7384658\n7384675\n7384655\n7384704\n7384709\n7384687\n7384706\n7384661\n7384662\n7384703\n7384670\n7384679\n7384678", "firm_fei_number": "2429304", "recalling_firm": "Olympus Corporation of the Americas", "address_1": "3500 Corporate Pkwy", "city": "Center Valley", "state": "PA", "postal_code": "18034-8229", "additional_info_contact": "Cynthia Ow\n647-999-3203", "reason_for_recall": "Certain serial numbers of the CV-190 do not start up properly because parts that deviated from the specification were assembled into the power supply unit.", "root_cause_description": "Nonconforming Material/Component", "action": "An URGENT: MEDICAL DEVICE FIELD CORRECTIVE ACTION notification letter dated 9/14/23 was sent to customers.\n\nAction steps to be taken by the end user:\nOlympus has determined based upon our distribution records that your facility is in possession of one or more affected CV-190 with a serial number shown in Attachment 1. Olympus requires that you take the following actions:\n1. Inspect your inventory for the referenced products and identify any devices with the model number and serial number specified in Attachment 1. Cease use of products and quarantine any affected products. Please check all areas of the hospital to determine if any of these products remain in inventory.\n2. Please contact our Olympus Repair Center at 1-800-848-9024, option 3, to arrange for a service to exchange the power supply unit in affected devices.\n\nOlympus regrets any inconvenience caused and fully appreciates your prompt cooperation in addressing this situation. If you require additional information, please do not hesitate to contact me at 647-999-3203 or Cynthia.Ow@Olympus.com.", "product_quantity": "45 units", "distribution_pattern": "US Nationwide distribution.", "openfda": { "k_number": [ "K160196", "K101191", "K103312", "K102616", "K202469", "K901610", "K070330", "K141598", "K181084", "K113050", "K810682", "K790338", "K132839", "K080317", "K173392", "K951575", "K051541", "K211819", "K954704", "K810654", "K230332", "K130718", "K141286", "K760452", "K260423", "K160356", "K100966", "K190649", "K131780", "K951578", "K210851", "K063654", "K120289", "K100624", "K181437", "K191220", "K244029", "K884857", "K220158", "K153483", "K112680", "K001241", "K052930", "K261587", "K792179", "K032688", "K210052", "K091305", "K220007", "K252457", "K182540", "K162330", "K163492", "K131855", "K961570", "K111756", "K961563", "K101053", "K231254", "K161355", "K192588", "K162428", "K051068", "K081004", "K943895", "K041903", "K801223", "K192664", "K112391", "K161791", "K250432", "K002749", "K111028", "K143732", "K232043", "K242110", "K210981", "K190669", "K230588", "K070622", "K083180", "K091783", "K951580", "K063585", "K172036", "K221452", "K213773", "K140595", "K822846", "K162622", "K121582", "K093037", "K173317", "K023259", "K132210", "K160015", "K090116", "K243261", "K180405", "K180285", "K810791", "K223827", "K232922", "K043487", "K970372", "K093187", "K213578", "K951579", "K242325", "K951574", "K173085", "K171673", "K192793" ], "device_name": "Colonoscope And Accessories, Flexible/Rigid", "medical_specialty_description": "Gastroenterology, Urology", "regulation_number": "876.1500", "device_class": "2", "registration_number": [ "", "3010009693", "9611680", "1651395", "3010390468", "2528981", "3042225166", "9681260", "8010047", "3005261802", "3014605202", "3004016520", "1222928", "3015451828", "3003637092", "3011816755", "3002808148", "1000121056", "3013505983", "3013184907", "3004111573", "3006546082", "3009420598", "2950776", "3005814162", "3006161756", "3011416394", "3002808022", "3022106566", "3015525240", "1220477", "3008386005", "2246552", "3010707607", "9610595", "3008879776", "3021246306", "3021008900", "3028058843", "3024021261", "3010288205", "3003775006", "2011171", "3017210488", "3014769442", "3012414760", "3014342096", "9616684", "1528319", "3009698186", "3010703925", "3013944123", "3015136743", "1047843", "3013023255", "3002807314", "3010202439", "3042172882", "3004052101", "3005099803", "3014279513", "3004644065", "3020707080", "9610877", "3023102955", "3010229237", "3008797804", "2020550", "3003782610", "1221826", "3011050570", "3015746529", "9611112", "9610617", "3012843412", "9614641", "3004705634", "3018258446" ], "fei_number": [ "", "1000122656", "3010009693", "3010390468", "3008185830", "2528981", "3042225166", "3005261802", "3014605202", "3004016520", "3015451828", "3003637092", "3011816755", "3002808148", "1000135740", "1000121056", "3013505983", "3013184907", "3007475226", "3004111573", "3006546082", "3009420598", "3005814162", "3011416394", "3002808022", "3022106566", "3008782585", "3015525240", "1220477", "3008386005", "2246552", "3002964398", "3010707607", "3008879776", "3021246306", "3021008900", "3028058843", "3002913962", "3024021261", "3010288205", "3003995201", "3003775006", "3002807969", "2011171", "3017210488", "3014769442", "3012414760", "3002806565", "3014342096", "3002808268", "1000120613", "3009698186", "3010703925", "3013944123", "3015136743", "1047843", "3013023255", "3002807795", "3002807314", "3042172882", "3004052101", "3005099803", "3014279513", "3004644065", "3020707080", "3003012447", "3023102955", "3010229237", "3008797804", "2020550", "3003782610", "1221826", "3011050570", "3015746529", "3002808127", "3012843412", "3004705634", "3018258446" ] } } ] }