{ "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": "158813", "product_res_number": "Z-0012-2018", "event_date_initiated": "2017-09-12", "event_date_created": "2017-10-17", "recall_status": "Terminated", "event_date_terminated": "2020-11-18", "res_event_number": "78166", "product_code": "JAA", "k_numbers": [ "K133553" ], "product_description": "Toshiba Medical Kalare Fluoroscopic X-Ray System (DREX-KL80) \n\n\nKalare is intended to be used as a universal diagnostic imaging system for radiographic and fluoroscopic examinations, including general R&F and pediatric examinations. It is intended for use by qualified/trained doctors or technologists on both adult and pediatric subjects taking radiographic and fluoroscopic exposures of the whole body, skull, spinal column, chest, abdomen, extremities, and other body parts. Applications can be performed with the patient sitting, standing or lying in prone or supine positions.", "code_info": "Model: HDR-08A", "firm_fei_number": "2020563", "recalling_firm": "Toshiba American Medical Systems Inc", "address_1": "PO Box 2068 2441 Michelle Dr", "address_2": "PO Box 2068", "city": "Tustin", "state": "CA", "postal_code": "92780-7047", "additional_info_contact": "714-730-5000", "reason_for_recall": "During an examination images were displayed on the live monitor,but the images were not displayed on the system monitor nor were they saved to the hard disk.", "root_cause_description": "Software design", "action": "Toshiba planned action to bring defect into compliance: \n\n1. You will issue a Customer Notification Letter to make customers aware of the hazards, what measures will be taken to remedy the defect at no cost to the user, and how to safely use the equipment before corrections can be made.\n\t\n2. You will install modified firmware on the systems to correct the defect and prevent recurrence.\n\n3. You will provide progress reports on the effectiveness of the plan. \n\nCDRH approves the CAP subject to the following conditions:\n\n1. Notification of all dealers and purchasers is to be made within 15 working days of receipt of this letter in the manner specified in 21 CFR 1003.21 and 1003.22. This office and the Food and Drug Administration (FDA) district office coordinator are to be included in the notification.\n\nThank you for your urgent attention to this matter. If you have any questions regarding this letter please feel free to call (800) 421-1968, or contact your local Toshiba Representative at (800) 521-1968. 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