{ "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": "196612", "product_res_number": "Z-0281-2023", "event_date_initiated": "2022-10-17", "event_date_posted": "2022-11-23", "recall_status": "Open, Classified", "res_event_number": "91055", "product_code": "OWN", "k_numbers": [ "K150018" ], "product_description": "VS3 Iridium - Visionsense Infrared (IR) Fluorescence Miniature Microscope (MMS) - 785nm\nProduct Number: 175-0012", "code_info": "UDI-DI: 10813040013711\nLot Numbers:\nSerial Number/Lot Number\n378-4005\n378-4514\n378-4516\n378-4517\n378-4518\n378-4519\n378-4520\n378-4521\n378-4522\n378-4523\n378-4525\n378-4526\n378-4527\n378-4528\n378-4534\n378-4586\n3784692\n3784693\n3784694\n3784696\n3784700\n3784701\n3784702\n3784703\n3784704\n3784784\n3784786\n3784787\n3784802\n3784803\n3784807\n3784808\n3784874\n3784875", "firm_fei_number": "3003143838", "recalling_firm": "Visionsense, Ltd.", "address_1": "20, Ha-Magshimim 20 Ha-Magshimim Petakh", "city": "Tikva", "country": "Israel", "additional_info_contact": "Medtronic Customer Service \n800-962-9888", "reason_for_recall": "XXX", "root_cause_description": "Under Investigation by firm", "action": "Medtronic issued Urgent Medical Device Correction Letter on 17-OCTOBER-2022 to US consignees via UPS 2-day delivery. For outside U.S. countries, notifications are handled via a regionally approved method. Letter states reason for recall, health risk and action to take:\n1.Prior to use, visually check the Beam-Combiner and MMS optical fiber cable for signs of being pinched, kinkedor damaged. Avoid folding the cables and handle with care to prevent damage.\n2.After the white balance has been performed as per IFU guidance, test the EleVision IR system at the beginningof the surgical procedure as follows:\na)Turn on the laser.\nb)For the laparoscopic configuration of the EleVision IR system, point the distal end of the endoscopetowards a bright surface, keeping the scope approximately 3 cm from the target. This prevents thewhite light from scattering. For the open configuration of the EleVision IR system, position the distalface of the MMS approximately 30 cm from any object. If you see a message on the screen indicatingthat the device is too close to tissue, move the device further away from the object until this messagedisappears.\nc)After two (2) seconds, the monitor screen should show a message indicating that the laser is on, ablinking red dot, and a running clock. If all these indications are seen properly on the monitor screen,turn off the laser after five (5) seconds.\nIf the screen does not show an indication that the laser is on, a blinking red dot, and a running clock, the laser is not functioning properly and the EleVision IR system should not be used in the surgical procedure.\nIf any pinching, kinking, or damage of the optical fiber cable is noted, or if the system does not work properly during the above-described laser test, do not use the system. Please report a complaint and arrange for servicing of the Beam Combiner and / or MMS device by contacting Medtronic at 1-800-255-6774 or rs.serviceexperience@medtronic.com.\n\nAdditional actions:\n\"Immediately notify", "product_quantity": "34 units: 15 units OUS; 19 units US", "distribution_pattern": "US Nationwide distribution.", "openfda": { "k_number": [ "K124031", "K142310", "K230407", "K172844", "K212695", "K201399", "K242163", "K243711", "K251852", "K191851", "K243591", "K213943", "K150018", "K200542", "K190729", "K220477", "K251336", "K133466", "K171238", "K203550", "K151593", "K160416", "K150831", "K233333", "K232857", "K191144", "K230754", "K191046", "K162882", "K202925", "K231344", "K241275", "K193416", "K123676", "K212322", "K254180", "K173866", "K253972", "K111047", "K192174", "K200737", "K192292", "K223020", "K143474", "K171345", "K122042", "K202244", "K152583", "K132389", "K110480", "K183453", "K260108", "K120208", "K141358", "K132475", "K210265", "K254242", "K221611", "K162885", "K231854", "K183640", "K152204" ], "registration_number": [ "3008309062", "3002808148", "3008837339", "3015895145", "3026753388", "3029968414", "3013077751", "9610773", "3013665681", "3001675293", "9614434", "3009057691", "3013868968", "3009719225", "3014644276", "3018094310", "3006990600", "9615010", "3016555232", "3041276556", "3010202439", "3016832577", "3015612252", "3017619652", "8010047", "3014635169", "3010885402", "3006973663", "3024021261", "3004542960", "3026934906", "3015532525", "2936485", "2027009", "3011092264", "3011063460", "3012627460", "8043903", "3012322232", "3010493171", "3011459664", "3012345110", "3007487007", "2020550", "3015153469", "3016607092", "3014663814", "3013247477", "1220246", "9614683", "3014321789", "3010177712", "3017820152", "3016493665", "3026606306", "3021744379", "3021336392", "9610617", "9612074", "3015224777", "2031093", "3010707607", "3010684280", "3014342096", "3015515531", "3010331645", "3007303113", "3015231789", "3010590422" ], "fei_number": [ "3003481798", "3008309062", "3002808148", "3008837339", "3015895145", "3026753388", "3029968414", "3013077751", "3013665681", "3001675293", "3009057691", "3013868968", "3009719225", "3002807798", "3018094310", "3006990600", "3002807795", "3016555232", "3041276556", "3002808088", "3007475226", "3016832577", "3002807072", "3001236549", "3015612252", "3017619652", "3006149253", "3014635169", "3010885402", "3006973663", "3024021261", "3004542960", "3026934906", "3015532525", "2936485", "3003794634", "2027009", "3011092264", "3011063460", "3012627460", "3012322232", "3010493171", "3011459664", "3012345110", "3007487007", "2020550", "3015153469", "3016607092", "3014663814", "3013247477", "1220246", "3014321789", "3010177712", "3017820152", "3016493665", "3026606306", "3021744379", "3021336392", "3015224777", "3010707607", "3010684280", "3014342096", "3015515531", "3010331645", "3002808268", "3002808273", "3007303113", "3015231789", "3010590422" ], "device_name": "Confocal Optical Imaging", "medical_specialty_description": "Gastroenterology, Urology", "regulation_number": "876.1500", "device_class": "2" } } ] }