{ "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": "149791", "product_res_number": "Z-0757-2017", "event_date_initiated": "2016-05-31", "event_date_created": "2016-12-14", "recall_status": "Terminated", "event_date_terminated": "2019-08-19", "res_event_number": "75249", "product_code": "EOQ", "k_numbers": [ "K131946" ], "product_description": "Ultrasound Video Bronchoscope \nThe EB-1970UK, Ultrasound Video Bronchoscope, is intended to provide optical visualization of, ultrasonic visualization of, and therapeutic access to, the Pulmonary Track including but not restricted to organs, tissues, and subsystem: Nasal Passage, Pharynx, Larynx, Trachea, Bronchial Tree (including access beyond the stem), and underlying areas. The instrument is introduced per orally when indications consistent with the requirement for procedure are observed in adult and pediatric patient populations.", "code_info": "EB-1970UK", "firm_fei_number": "1000080301", "recalling_firm": "Pentax of America Inc", "address_1": "3 Paragon Dr", "city": "Montvale", "state": "NJ", "postal_code": "07645-1782", "additional_info_contact": "Mr. Paul Silva\n973-628-2199", "reason_for_recall": "The EB-1970UK Ultrasound Video Bronchoscope shipped between the\nclearance date of April 2014 and September 2015 contained the Operation and\nReprocessing IFUs that were in use prior to the 2014 clearance, and therefore did not\ninclude the cleared Operation and Reprocessing IFUs.", "root_cause_description": "Process control", "action": "Pentax sent a US Urgent Field Correction letter to all affected customers with a field correction/field safety response form via USPS on May 31, 2016. The letter identified the product, the problem, and the action to be taken by the customer. \nRevised instructions were as follows:\nThe instructions have been revised in the following manner:\n Operation IFU\no Integrated all models of each family into the IFU\no Modified the indications for use language to be consistent with similar products\no Enhanced the explanation of the operation of the device\no Revised and added cautions and warnings\n Reprocessing IFU\no Included more specificity regarding reprocessing activities to aid in the proper method for reprocessing the\nendoscopes, including:\n number of brush and rinse steps,\n quantity of fluid volumes,\n use of additional text, figures, cautions, and warnings\nIdentification of Affected Endoscope Models\nTable 1 provides an overview of the Affected Endoscope models, and the part number and revision of the historical and\nrevised IFUs. The accompanying USB flash drive contains all the revised IFUs identified below. Please distribute only those\nIFUs which support the products owned by your facility.\nTable 1\nAffected Models Historical Version of IFUs Revised IFUs\nEB-1970UK\nUltrasound Video Bronchoscope\nZ870 Owners IFU\nS016_R02 Operator IFU\nS021_R04 Reprocessing IFU\nNo.388_R01 Addendum\nNo.392_R00 Addendum\nEB-70K series\nVideo Bronchoscopes\nZ705 Operation IFU S015_R04 Operator IFU\nS020_R04 Reprocessing IFU\nNo.388_R01 Addendum\nNo.392_R00 Addendum\nZ706 Reprocessing IFU\nEB-75K series\nVideo Bronchoscopes\nS003 Owners IFU\n\nCustomers were instructed to ensure that user departments discard the prior versions of the Instructions for Use and ensure that all users read and carefully follow the revised Operation and Reprocessing IFUs to ensure the proper use and cleaning of the affected PENTAX endoscopes. Customers were advised to contact their PEN", "product_quantity": "113 units", "distribution_pattern": "Nationwide Distribution", "openfda": { "k_number": [ "K974642", "K944650", "K231107", "K022546", "K212886", "K040940", "K933433", "K921393", "K182253", "K242793", "K220299", "K163377", "K061313", "K171291", "K210379", "K931154", "K896146", "K213782", "K980046", "K232860", "K854581", "K952081", "K950786", "K211947", "K792267", "K211169", "K233671", "K962367", "K242416", "K223836", "K210883", "K962378", "K173554", "K253137", "K954707", "K944649", "K941264", "K071530", "K232984", "K233779", "K182188", "K024165", "K833483", "K934920", "K183516", "K222861", "K201758", "K822180", "K183654", "K243219", "K211030", "K832492", "K911922", "K252045", "K033225", "K202987", "K822844", "K951199", "K220399", "K192164", "K151315", "K230428", "K983124", "K242324", "K210928", "K940521", "K914181", "K963033", "K212048", "K191948", "K250862", "K193534", "K152319", "K122535", "K962555", "K832449", 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"3001675293", "3015153469", "3023460764" ], "device_name": "Bronchoscope (Flexible Or Rigid)", "medical_specialty_description": "Ear, Nose, Throat", "regulation_number": "874.4680", "device_class": "2" } } ] }