{ "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": "190961", "product_res_number": "Z-0516-2022", "event_date_initiated": "2021-10-12", "event_date_created": "2022-01-21", "recall_status": "Terminated", "event_date_terminated": "2024-04-11", "res_event_number": "89260", "product_code": "OWB", "k_numbers": [ "K193326" ], "product_description": "Artis icono biplane with software VE20C-diagnostic imaging angiography system\nModel: 11327600", "code_info": "Serial Numbers:\n180062\n180318\n180054\n180019\n180065\n180057\n180041\n180317\n180034\n180072\n180349\n180060\n180337\n180070\n180048\n180083\n180369\n180370\n180345\n180315\n180343\n180080\n180301\n180305\n180067\n180330\n180040\n180360\n180333\n180029\n180352\n180336\n180316\n180068\n180363\n180084\n180334\n180018\n180350\n180354\n180046\n180047\n180335\n180085\n180035\n180339\n180357\n180358\n180361\n180362\n180081\n180331\n180021\n180342\n180321\n180309\n180356\n180368\n180341\n180323\n180329\n180043\n180049\n180077\n180086\n180053\n180055\n180015\n180014\n180066\n180082\n180037\n\nUDI: 04056869063317\n\nExpanded Recall 12/20/21\nS/N: 180056", "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": "Four potential software issues with Artis pheno and Artis icono systems with software VE20C: 1.\tUpdated calibration data not saved with measurement after scene+/-; 2.\tNo x-ray possible, system shutdown/restart might be required during intervention; 3. Corrupted Image during Roadmap;\n4.\tUnintended shutdown of Imaging System with UPS (Uninterruptable Power Supply) option", "root_cause_description": "Software design", "action": "Siemens issued A Customer Safety Advisory Notice dated 10/12/21 to affected customers via AX047/21/S. Additionally, a software update will be initiated for all affected users via Update Instruction AX046/21/S. Letter states reason for recall, health risk and action to take:\nTo avoid inaccurate measurement values, repeat the distance measurements after changing the Auto TOD Calibration or Distance Calibration of the scene. Additionally, before closing the image after performing the calibration, create a screenshot/secondary capture image for post review.\n\nThe Operator Manual of the affected systems will be updated according to the information mentioned above. This is regarded as an interim solution until the next software update is available. The Operator Manual update will draw attention to the issue.\n\nWe do not consider it necessary to re-examine any patients in relation to the issues (issue 1 to 4) described above. If measurements have already been performed in the past for diagnostics, please verify the results and diagnostic evaluation if applicable.\nSiemens will correct the software error via Update Instruction AX046/21/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.", "product_quantity": "72 units", "distribution_pattern": "US Nationwide distribution.", "openfda": { "k_number": [ "K133580", "K022069", "K982993", "K240099", "K222080", "K254173", "K093066", "K221922", "K252735", "K002016", "K123508", "K013608", "K142736", "K113027", "K181943", "K130638", "K060259", "K200917", "K070834", "K170752", "K120073", "K103425", "K936180", "K181670", "K030544", "K183144", "K201172", "K041605", "K251199", "K252068", "K190768", "K221281", "K212159", "K243328", "K200022", "K152696", "K212557", "K260607", "K251523", "K142126", "K211191", "K133292", "K961374", "K190064", "K152697", "K923049", "K221335", "K240465", "K252229", "K211782", "K241572", "K921219", "K000221", "K240224", "K160279", "K200887", "K222070", "K183101", "K122234", "K211064", "K111551", "K203281", "K093688", "K082243", "K143225", "K203504", "K181966", "K083725", "K031637", "K223410", "K053279", 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