{ "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": "2026-08-20", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "205360", "product_res_number": "Z-0690-2024", "event_date_initiated": "2023-12-04", "event_date_posted": "2024-01-09", "recall_status": "Open, Classified", "res_event_number": "93583", "product_code": "FAJ", "k_numbers": [ "K221683" ], "product_description": "Model No. CYF-VHR, CYSTO-NEPHRO VIDEOSCOPE", "code_info": "UDI-DI: 04953170310522;\n04953170411298\n\n\n\nAll serial numbers", "firm_fei_number": "3002808148", "recalling_firm": "Shirakawa Olympus Co., Ltd.", "address_1": "Azaokamiyama 3-1 3-1 azaokamiyama", "city": "Nishigo-Mura Nishishirakawa-Gun", "country": "Japan", "additional_info_contact": "Cynthia Ow\n81248-27-2239", "reason_for_recall": "Olympus has updated the instructions for use: Reusable cleaning brushes have been removed from the manual cleaning. Single use brushes remain compatible.", "root_cause_description": "Under Investigation by firm", "action": "On December 4, 2023, the firm notified customers of the recall via URGENT MEDICAL DEVICE CORRECTION letters.\n\nCustomers were informed of the updates to the instructions for use (IFU). Customers were instructed to ensure all personnel are completely knowledgeable and thoroughly trained on the changes to the reprocessing instructions. Please locate and replace any on-hand copies of the IFU with the updated version.\n\nThe most current version of the Instructions for Use can be obtained from the Olympus Connect customer web portal at https://www.OlympusConnect.com. New users will need to register. Once registered select the Product Support button on the left navigation bar, select the [Reprocessing Manuals] button, locate the BF-P190 and BF-XP190 Instructions for Use and select the [Download] button.\n\nIf you require additional information, please contact the firm directly by phone at (647) 999-3203 or by e-mail at Cynthia.Ow@olympus.com", "product_quantity": "1547 US; 2772 OUS", "distribution_pattern": "US Nationwide distribution.", "openfda": { "k_number": [ "K993041", "K170862", "K040215", "K212476", "K240849", "K240663", "K760189", "K003807", "K930827", "K860822", "K240848", "K980592", "K943176", "K093725", "K223040", "K914008", "K222602", "K241500", "K202957", "K181909", "K202921", "K033191", "K221690", "K193095", "K021074", "K960872", "K000197", "K060899", "K253226", "K043022", "K212202", "K242535", "K222162", "K992483", "K003988", "K120766", "K993689", "K252176", "K231118", "K240283", "K090814", "K922320", "K820851", "K760274", "K953201", "K191357", "K072180", "K945262", 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