{ "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": "122033", "product_res_number": "Z-0140-2014", "event_date_initiated": "2013-09-03", "event_date_posted": "2013-11-27", "recall_status": "Terminated", "event_date_terminated": "2015-03-09", "res_event_number": "66314", "product_code": "JAA", "k_numbers": [ "K062623", "K101491" ], "product_description": "Siemens RAD Fluoro Uro system (Luminos dRF and Uroskop Omnia with software version VD10A/G\n\nImage intensified Fluoroscopic X-ray system", "code_info": "Model numbers 10094910 and 10094200 with software version VD10A/G.", "firm_fei_number": "2240869", "recalling_firm": "Siemens Medical Solutions USA, Inc", "address_1": "51 Valley Stream Pkwy", "city": "Malvern", "state": "PA", "postal_code": "19355", "additional_info_contact": "Customer Support\n610-219-6300", "reason_for_recall": "When using systems operating with software versions VD10A/G during a RAD examination, a malfunction can result in radiation continuing longer than required resulting in an overexposed image that is not of diagnostic quality, prompting repetition of the examination.", "root_cause_description": "Software design", "action": "Siemens sent an Field Safety Notice dated September 3, 2013, to all affected customers.The letter identified the product the problem and the action to be taken by the customer. \n\nAction to be taken: \n1. It is not possible for the user to prevent this malfunction. The exposure time with the use of automatic exposure control is limited to 500ms, which is the maximum duration of radiation in this mode. The exposure can be interrupted by the user at anytime by releasing the exposure button.\n\n2. There are two possibilities to solve this issue:\n\na.) Switch off the system if the message \"wait for FLC\" in status bar does not disappear approximately. 30s after the OGP selection. The system gets ready after switching the system on and reselecting the Torno OGP.\n\nb.) Press Shift+F10. The pop up message has to be confirmed and you have to wait approximately.\n40s until! the \"i\" icon in the status bar stops blinking. After that a RAD OGP has to be selected and then the Torno OGP. Thereafter, the system gets ready.\n\n3. It is not possible for the user to prevent this malfunction\n\nThe Center for Devices and Radiological Health (CDRH) understands that your\nCorrective Action Plan (CAP) will involve 59 units and consist of the following elements:\n1. You have notified affected customers with Field Safety Notice XP032/13/S.\n2. You have prepared a field modification of the Luminos dRF and Uroskop Omnia\nsystems with software version VD10A/G.\n3. Distribution of this field modification will began in September 2013 as Update\nInstruction XP015/13/S at no cost to the user.\n\nFor further Customer Support call (610) 219-6300.", "product_quantity": "59", "distribution_pattern": "Worldwide Distribution - USA (nationwide) and Internationally to Canada.", "openfda": { "k_number": [ "K840134", "K890745", "K922013", "K923453", "K081091", "K973073", "K913012", "K151485", "K801948", "K933472", "K970608", "K191713", "K992603", "K812963", "K111292", "K961193", "K884028", "K893644", "K973744", "K902982", "K944973", "K912341", "K024012", "K840364", "K930885", "K022911", "K993896", "K982028", "K813217", "K902980", "K910384", "K901671", "K926122", "K022899", "K922012", "K133434", "K820178", "K954590", "K950631", "K840191", "K812217", "K042698", "K132106", "K840390", "K925251", "K131075", "K875157", "K964322", "K912470", "K946081", "K883985", "K943447", "K954945", "K936236", "K953950", "K232526", "K982345", "K061028", "K233380", "K112054", 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