{ "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": "2026-09-12", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "217578", "product_res_number": "Z-1008-2026", "event_date_initiated": "2025-12-05", "event_date_posted": "2025-12-31", "recall_status": "Open, Classified", "res_event_number": "98076", "product_code": "HQF", "k_numbers": [ "K240615" ], "product_description": "BVI Leos Laser and Endoscopy System. Model Number: OME6000U.", "code_info": "Model Number: OME6000U. UDI: (01)00886158037576(11)250513(21). Serial Numbers: 77UBV500003, 77UBV500004, 77UBV500005, 77UBV500006, 77UBV500010.", "firm_fei_number": "1211998", "recalling_firm": "Beaver-Visitec International, Inc.", "address_1": "500 Totten Pond Rd", "city": "Waltham", "state": "MA", "postal_code": "02451-1916", "additional_info_contact": "Silvana Brown\n952-737-7242", "reason_for_recall": "Manufacturing deviation in which the ferrites specified for the USB cable assembly linking the Nurse Monitor touchscreen to the System Controller were not installed as intended. The omission of the ferrites on the USB communication cable results in non-conformance to the design specifications, which require two ferrites (one at each end of the cable).", "root_cause_description": "Process control", "action": "Beaver-Visitec International (BVI) notified consignees via emailed letter on 12/05/2025. Consignees were informed that the affected units can still be used. A BVI service technician will contact each consignee to schedule a visit. During this visit, the missing ferrites will be installed to restore the equipment to its fully compliant and validated configuration. BVI aims to complete the correction by December 31st, 2025.", "product_quantity": "5 units", "distribution_pattern": "US Nationwide distribution in the states of FL, MI, OK, TX, WI.", "openfda": { "k_number": [ "K904366", "K843965", "K140362", "K904699", "K910612", "K152688", "K041598", "K142830", "K220430", "K981196", "K031023", "K893709", "K220877", "K834305", "K841856", "K900199", "K051944", "K100253", "K971950", "K832089", "K905453", "K854288", "K031665", "K862568", "K122202", "K133019", "K812219", "K990075", "K972514", "K100019", "K111460", "K964751", "K201502", "K875000", "K853890", "K863246", "K852464", "K171488", "K251772", "K860358", "K942180", "K043613", "K120825", "K894273", "K881134", "K230350", "K170067", "K142398", "K881494", "K890086", "K081774", "K020374", "K935747", "K952894", "K903421", "K932836", "K072823", "K061024", "K111108", "K033941", "K834060", "K882908", "K043236", "K833533", "K840590", "K862987", "K960522", "K781965", "K832316", "K063297", "K252979", "K050807", "K140336", "K973220", "K124043", "K213592", "K782065", "K070776", "K885164", "K842251", "K133358", "K840145", "K850572", "K212630", "K926470", "K190448", "K863591", "K232417", "K895196", "K890509", "K840854", "K791659", "K883213", "K153769", "K243014", "K112154", "K123542", "K834610", "K131207", "K091534", "K852234", "K242397", "K844357", "K833532", "K091581", "K231011", "K873460", "K232051", "K222395", "K203130", "K894835", "K192045", "K872846", "K111643", "K180402", "K813492", "K001772", "K960971", "K130195", "K152603", "K220974", "K013760", "K893630", "K925663", "K842250", "K062074", "K910532", "K092621", "K091981", "K842412", "K181682", "K895213", "K973193", "K021538", "K844358", "K854949", "K040209", "K222157", "K080423", "K090774", "K864063", "K951079", "K081565", "K142172", "K233911", "K844668", "K103547", "K103056", "K223132", "K931784", "K201623", "K782106", "K801336", "K230228", "K062624", "K091064", "K023094", "K230722", "K990665", "K870839", "K905141", "K852529", "K202760", "K121187", "K123056", "K081946", "K010372", "K932296", "K251507", "K833232", "K833274", "K050541", "K130933", "K874609", "K240615", "K190083", "K170302", "K882372", "K841855", "K910805" ], "pma_number": [ "P990078" ], "registration_number": [ "2028159", "", "1928237", "1054713", "2031962", "3045817901", "3002991496", "3038356864", "1047843", "3005012805", "1313525", "3008252121", "3010208880", "2939653", "2247224", "3008156177", "9615745", "3016405041", "1920664", "3020611964", "3005350457", "1018470", "3012037425", "3002807715", "2246552", "3015658550", "3001592626", "1526711", "3009462521", "9615030", "1650907", "3010849408", "9611516", "3010220595", "3007589150", "3030860039", "3005941719", "1644019", "3009337401", "8043792", "3004497289", "9681121", "3004858034", "9680671", "3002808022", "1211998", "8030988", "8030392", "3007851054", "3009026057", "3013515803", "3004467263", "3009298127", "1222616", "2529392", "3010487482", "1000391004", "1932180", "3029221947", "3016678045", "3027683457", "2936921", "3002807090" ], "fei_number": [ "", "1928237", "3045817901", "3002991496", "3038356864", "1047843", "3005012805", "3008252121", "3010208880", "3002807944", "1000125771", "3003559308", "2939653", "3016405041", "1920664", "3005350457", "1018470", "3012037425", "3002807715", "2246552", "3001362763", "3015658550", "3003282815", "3002807111", "3000314405", "1526711", "1317628", "3009462521", "3001592626", "3002808269", "3002445546", "3010849408", "3010220595", "3007589150", "3002806863", "1000119305", "3030860039", "3003465293", "1000120916", "3009337401", "3002681132", "3004497289", "3004858034", "3002806902", "1000121498", "3002808022", "1211998", "3007851054", "3009026057", "1000114111", "3004467263", "3009298127", "1720381", "1000117501", "1000122089", "3010487482", "1000391004", "3029221947", "3016678045", "3027683457", "2936921", "3006003617" ], "device_name": "Laser, Ophthalmic", "medical_specialty_description": "Ophthalmic", "regulation_number": "886.4390", "device_class": "2" } } ] }