{ "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": "2026-08-13", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "210213", "product_res_number": "Z-0232-2025", "event_date_initiated": "2024-09-24", "event_date_posted": "2024-10-25", "recall_status": "Open, Classified", "res_event_number": "95423", "product_code": "OWN", "k_numbers": [ "K143474" ], "product_description": "Quest Spectrum 3 Fluorescent Imaging System\nModel/Catalog Number: ART-SYS-0029, ART-SYS-0030\n\n The Quest Spectrum3 is a fluorescent imaging system used in capturing and viewing fluorescent images for the visual assessment of blood flow for the evaluation of tissue perfusion, and related tissue-transfer circulation in tissue and free flaps used during plastic and reconstructive surgeries.", "code_info": "UDI-DI: 08719324487047\nLot Code: Model: ART-SYS-0029, Serial: ART-SYS-2022-F04, ART-SYS-2022-A06, ART-SYS-2022-F05; \nModel: ART-SYS-0030; No distribution in the USA", "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\n647-9993203", "reason_for_recall": "Does not meet the requirements for electromagnetic compatibility (EMC) of the standard IEC 60601-1-2. \nElectromagnetic interference occurring during a procedure may cause the device to malfunction requiring the replacement of the device. This could potentially result in a prolonged procedure and/or require additional medical intervention", "root_cause_description": "Component design/selection", "action": "Olympus issued Urgent Medical Correction letter to Operating Room Director, Risk Management on 9/24/24. Letter states reason for recall, health risk and action to take:\n1. Carefully read the content of this notification.\n2. Quarantine and mark you Spectrum 3 unit appropriately to prevent usage.\n3. Ensure all personnel are completely knowledgeable and thoroughly trained on the content of this notification.\n4. Acknowledge receipt of this letter through the Olympus recall portal:\na. Go to https://olympusamerica.com/recall\nb. Enter the recall number \"0456 \nc. Complete the form as instructed.\n5. If you have further distributed this product, identify your customers, and forward them this notification.\nOlympus requests that you report any complaints or any associated injuries to the Technical Assistance Center (TAC) at 1- 800-848-9024, option 1, and the FDA. Adverse events experienced with the use of this product may also be reported to the FDA s MedWatch Adverse Event Reporting program either online, by regular mail, or by fax.\nOlympus fully appreciates your prompt cooperation in addressing this situation. \nIf you require additional information, please do not hesitate to contact me directly by phone at (647) 999-3203 or by e-mail at Cynthia.Ow@Olympus.com.", "product_quantity": "3 units", "distribution_pattern": "OH", "openfda": { "k_number": [ "K220477", "K212322", "K200737", "K133466", "K202244", "K230407", "K162882", "K152583", "K132389", "K150018", "K231344", "K203550", "K111047", "K122042", "K253972", "K241275", "K251336", "K173866", "K123676", "K254180", "K151593", "K202925", "K192174", "K243591", "K254242", "K251852", "K242163", "K172844", "K221611", "K200542", "K171345", "K210265", "K231854", "K110480", "K191046", "K162885", "K201399", "K212695", "K124031", "K142310", "K141358", "K120208", "K171238", "K183640", "K152204", "K183453", "K193416", "K223020", "K233333", "K243711", "K191144", "K191851", "K192292", "K230754", "K213943", "K260108", "K190729", "K232857", "K160416", "K132475", "K143474", "K150831" ], "registration_number": [ "3010331645", "8043903", "3011092264", "3012322232", "3011459664", "3017820152", "9614434", "3021336392", "3026753388", "3026934906", "9610773", "3010177712", "3014635169", "3018094310", "3015153469", "3002808148", "3013868968", "3010493171", "3016607092", "3004542960", "3008837339", "3029968414", "2031093", "3026606306", "3014321789", "1220246", "2020550", "3010885402", "3013247477", "3009057691", "3015224777", "8010047", "3010684280", "3015895145", "3010202439", "3011063460", "3006990600", "3015612252", "3012345110", "3010707607", "3015231789", "3024021261", "3007487007", "2936485", "3041276556", "3013665681", "3017619652", "9612074", "9610617", "3015532525", "3014342096", "3014644276", "3012627460", "3021744379", "3007303113", "3008309062", "9614683", "3016493665", "2027009", "3016555232", "3009719225", "3016832577", "3014663814", "3006973663", "3010590422", "3015515531", "9615010", "3013077751", "3001675293" ], "fei_number": [ "3010331645", "3011092264", "3012322232", "3011459664", "3017820152", "3021336392", "3026753388", "3026934906", "3002808273", "3010177712", "3014635169", "3018094310", "3015153469", "3002808148", "3007475226", "3013868968", "3010493171", "3016607092", "3004542960", "3008837339", "3029968414", "3001236549", "3026606306", "3014321789", "1220246", "2020550", "3010885402", "3013247477", "3009057691", "3015224777", "3002807795", "3010684280", "3003481798", "3015895145", "3011063460", "3006990600", "3015612252", "3012345110", "3010707607", "3007487007", "3024021261", "2936485", "3041276556", "3013665681", "3017619652", "3002807072", "3006149253", "3015532525", "3014342096", "3012627460", "3021744379", "3007303113", "3008309062", "3016493665", "2027009", "3016555232", "3003794634", "3009719225", "3016832577", "3014663814", "3010590422", "3015515531", "3002808088", "3002807798", "3015231789", "3006973663", "3002808268", "3013077751", "3001675293" ], "device_name": "Confocal Optical Imaging", "medical_specialty_description": "Gastroenterology, Urology", "regulation_number": "876.1500", "device_class": "2" } } ] }