{ "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": "2026-09-10", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "194235", "product_res_number": "Z-1339-2022", "event_date_initiated": "2022-02-25", "event_date_created": "2022-07-06", "recall_status": "Open, Classified", "res_event_number": "90366", "product_code": "OWB", "k_numbers": [ "K163286", "K190768", "K193326", "K201156" ], "product_description": "syngo Application software VE20 (Material Number 10848815) installed on the Artis pheno and Artis icono systems as follows:\n(1) Artis pheno\nModel Number:10849000\n(2) Artis icono biplane\nModel Number: 11327600\n(3) Artis icono floor\nModel Number: 11327700", "code_info": "(1)Artis Pheno UDI-DI: 04056869046877\n(2)Artis icono biplane UDI-DI: 04056869063317\n(3) Artis icono floor- UDI-DI: 04056869149325\n\nS/N:\nSerial \n170319\n180062\n180054\n180019\n164719\n164712\n180065\n180056\n180057\n180041\n180421\n180317\n180034\n164740\n180349\n180301\n164722\n180367\n180382\n180060\n164311\n170026\n180337\n164763\n180070\n180048\n180083\n164735\n180087\n180370\n180371\n180372\n180345\n180315\n170367\n170368\n164723\n180343\n180080\n180305\n180330\n170331\n164743\n180379\n180386\n164741\n180360\n180333\n170349\n170361\n180029\n180352\n180336\n180407\n164728\n180412\n180400\n180397\n180316\n180068\n180363\n170334\n170336\n180084\n180418\n180334\n164711\n170025\n180018\n180350\n180376\n180354\n180046\n180047\n180335\n180085\n164321\n180035\n164718\n180339\n180357\n180358\n180361\n180362\n180081\n180423\n170346\n180331\n180411\n180381\n180021\n180342\n170365\n170322\n180321\n180309\n180356\n180378\n180393\n164739\n180368\n180413\n180341\n164703\n180323\n170303\n170378\n180329\n180053\n180055\n164721\n180043\n170053\n180049\n180377\n180077\n180086\n180015\n180014\n164726\n164724\n164725\n180066\n180082\n164760\n180037\n180373", "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": "After CT image data from Toshiba is loaded, image mirroring can occur along the horizontal and vertical image axes. If this error occurs, the patient orientation/position may be misinterpreted and result in inappropriate treatment, even if the incorrect visualization is obvious.", "root_cause_description": "Software design", "action": "Siemens Medical Solutions USA, Inc. initiated a Customer Safety Advisory Notice to customers via AX007/22/S dated 2/25/22. \nLetter states reason for recall, health risk and action to take:\nWe do not consider it necessary to re-examine any patients previously treated using the syngo application software. \n\nSiemens will correct the software error via Update Instruction AX006/22/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. Following the correction, the cause is eliminated, and any recurrence of this potential fault is prevented.\n\nPlease review, understand, and confirm acknowledgement of the information and instructions outlined in this Urgent Safety Advisory Notice. By signing this document, you are acknowledging that you have read and understand the content therein", "product_quantity": "127 units", "distribution_pattern": "US Nationwide.", "openfda": { "k_number": [ "K202360", "K260607", "K222080", "K123226", "K251199", "K222998", "K041931", "K202547", "K122644", "K073543", "K220432", "K251827", "K211780", "K022069", "K912448", "K982993", "K101868", "K161839", "K091918", "K070834", "K152697", "K160279", "K231700", "K132970", "K230950", "K243884", "K130638", "K233200", "K052412", "K161563", "K111551", "K153232", "K210054", "K252500", "K152785", "K251992", "K102529", "K122457", "K151904", "K113027", "K172307", "K143281", "K241572", "K220311", "K082781", "K960920", "K123529", "K182415", "K151000", "K212159", "K120073", "K253726", "K052202", "K041932", "K211191", "K251893", "K212523", "K141574", "K212557", "K140041", "K221230", "K192182", "K240224", "K152696", "K191503", "K252099", "K210309", "K252068", "K193230", "K982427", "K181415", "K201172", 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