{ "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": "160059", "product_res_number": "Z-0232-2018", "event_date_initiated": "2017-06-15", "event_date_created": "2017-12-10", "recall_status": "Terminated", "event_date_terminated": "2018-05-09", "res_event_number": "78644", "product_code": "KPR", "k_numbers": [ "K152294" ], "product_description": "FUJIFILM FDR Visionary Suite with CH-200. Model # CH-200, Catalog: Visionary Suite (FMSU Marketing Name)\n\nThe FDR Visionary Suite is intended to generate digital or conventional radiographic images of the skull, spinal column, chest, abdomen, extremities, and other body parts of human anatomies in all routine radiography examinations.", "code_info": "UDI: (01)04540217052226(21)MP95A9F6B001; (01)04540217052226(21)MP95A9F6A001; (01)04540217052226(21)MP95A8F5A001.  Serial Numbers: FDR Visionary Suite System S/N MP95A9F6B001 MP95A9F6A001 MP95A8F5A001", "firm_fei_number": "1000513161", "recalling_firm": "Fujifilm Medical Systems U.S.A., Inc.", "address_1": "419 West Ave", "city": "Stamford", "state": "CT", "postal_code": "06902-6343", "reason_for_recall": "A potential issue in the X-ray tube ceiling unit CH-200 which constitutes the Digital Radiography System FDR Visionary Suite. The X-ray tube assembly in these devices is mounted to a tube mounting flange, which is part of the tube holding shaft. where cracks may occur over time on the tube holding shaft near the base of the tube\nmounting flange.", "root_cause_description": "Device Design", "action": "FUJIFILM Medical Systems U.S. A. Inc. (FMSU) sent \"Urgent: Medial Device Correction\" recall notification letter dated June 21, 2017 to all Customers. Customers were notified of the recall, potential issue, potential hazard, description of the issue, the actions planned to correct the issue, the actions to be taken by the customer and contact information. A Customer Feedback Form was provided accompanying the letter.\n\nFMSU service personnel will contact all of the medical facilities where the applicable products have been installed to arrange for this correction and visit to take corrective measures. As FMSUs planned field correction at the affected sites, FMSU will install the additional protective parts preventing the X-ray tube assembly from coming into contact with the patient or operator should separation of the tube mounting flange from the tube holding shaft occur.\n\nFor further questions, please call (203) 324-2000.", "product_quantity": "3", "distribution_pattern": "US Distribution.", "openfda": { "k_number": [ "K193637", "K102285", "K152767", "K033345", "K981056", "K071430", "K190601", "K012546", "K250954", "K082261", "K833559", "K973710", "K192453", "K201725", "K080614", "K190330", "K953832", "K061595", "K945709", "K904676", "K151924", "K233532", "K180543", "K902378", "K173517", "K910757", "K071401", "K172869", "K942792", "K121513", "K103448", "K811230", "K931071", "K771051", "K870300", "K072659", "K760205", "K250788", "K140326", "K102349", "K220271", "K921539", "K133959", "K101042", "K091752", "K781983", "K082064", "K121345", "K233381", "K202394", "K231995", "K181279", 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