{ "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": "190132", "product_res_number": "Z-0299-2022", "event_date_initiated": "2021-10-20", "event_date_created": "2021-11-24", "recall_status": "Terminated", "event_date_terminated": "2024-06-18", "res_event_number": "88962", "product_code": "OWB", "k_numbers": [ "K181407" ], "product_description": "Artis zee biplane with software VD12-angiography systems developed for single and biplane diagnostic imaging and interventional procedure \nModel Number: 10094141", "code_info": "Serial Numbers: 156011 156014", "firm_fei_number": "2240869", "recalling_firm": "Siemens Medical Solutions USA, Inc", "address_1": "40 Liberty Blvd", "city": "Malvern", "state": "PA", "postal_code": "19355-1418", "additional_info_contact": "SAME\n610-219-4834", "reason_for_recall": "If SID (source-to-image distance) lift movement is activated and x-ray shall be released simultaneously; x-ray is not possible and the message No x-ray, try again is displayed, may result in a short delay in procedure", "root_cause_description": "Software design", "action": "Siemens Medical Solutions USA, Inc. initiated a Customer Safety Advisory Notice dated 10/202/1 to customers via AX070/21/S, Siemens will update the system software via Update Instruction AX069/21/S. Letter states reason for recall, health risk and action to take:\nTo avoid the problem, it is recommended to position the SID first and then release x-ray.\n\nSiemens will correct the software error (software VD12) via Update Instruction AX069/21/S. Our service organization will contact you shortly to arrange a date to perform this corrective action. Please feel free to contact our service organization for an earlier appointment at 1-800-888-7436. We do not consider it necessary to re-examine any patients in relation to the issues described above.\n\nPlease review, understand, and confirm acknowledgement of the information and instructions outlined in this Urgent Safety Advisory Notice. 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