{ "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": "203511", "product_res_number": "Z-0195-2024", "event_date_initiated": "2023-09-12", "event_date_posted": "2023-10-27", "recall_status": "Open, Classified", "res_event_number": "93127", "product_code": "OWB", "k_numbers": [ "K210055" ], "product_description": "Siemens Cios Alpha (VA30) mobile fluoroscopic C-arm X-ray System, designed for the surgical environment. \n11105200", "code_info": "***Updated 12/4/23***\nUDI-DI: 04056869153490\nS/N: \n40013\n40014\n40015\n40018\n40020\n40023\n40030\n40032\n40033\n40034\n40035\n40036\n40039\n40040\n40046\n40047\n40048\n40049\n40050\n40051\n40052\n40054\n40055\n40057\n40058\n40062\n40070\n40073\n40075\n40076\n40077\n40078\n40080\n40083\n40084\n40093\n40094\n40095\n40102\n40103\n40104\n40107\n40108\n40109\n40110\n40111\n40116\n40117\n40119\n40121\n40122\n40123\n40124\n40125\n40126\n40130\n40134\n40135\n40137\n40139\n40157\n40158\n40160\n40161\n40162\n40163\n40164\n40167\n40168\n40169\n40170\n40171\n40174\n40175\n40176\n40188\n40189\n40190\n40191\n40192\n40193\n40194\n40196\n40206\n40208\n40215\n40220\n40226\n40228\n40230\n40231\n40234\n40236\n40238\n40239\n40240\n40242\n40244\n40245\n40246\n40248\n40250\n40251\n40252\n40255\n40256\n40257\n40259\n40261\n40263\n40264\n40265\n40266\n40267\n40268\n40270\n40271\n40273\n40276\n40314\n40315\n40317\n40318\n40322\n40323\n40324\n40336\n40339\n42001\n42002\n42003\n42004\n42005\n42006\n42010\n42018\n42024\n42025\n42028\n42032\n42033\n42037\n42040\n42041\n42042\n42045\n42046\n42052\n42057\n42061\n42068\n42069\n42082\n42087\n42094\n42101\n42111\n42140\n42141\n42146\n42147\n42148\n42156\n42160\n42161\n42185\n42186\n42187\n42188\n42189\n42190\n42191\n42196\n42199\n42202\n43000\n43002\n43003\n43006\n43007\n43013\n43022\n43023\n43025\n43026\n43027\n43028\n43029\n43031\n43033\n43034\n43037\n43042\n43044\n43045\n43046\n43048\n43049\n43055\n43058\n43060\n43061\n43062\n43063\n43072\n43073\n43076\n43079\n43086\n43095\n43105\n43106\n43108\n43112\n43142\n43143\n43150\n43161\n43163\n43177\n43193\n43208\n43222\n43226\n43231\n43257\n43261\n43279\n43283\n43286\n43289\n43291\n43296\n43297\n43298\n43319\n43339", "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": "Meredith Adams\n610-219-4834", "reason_for_recall": "Software issue for Cios Alpha, Cios Flow, and Cios Spin VA30 systems, fulfillment of new requirements from DIN and IEC standards for Cios VA30 systems required may result in patient misdiagnosis/repeat exposure", "root_cause_description": "Software design", "action": "Siemens Medical Solutions USA issued Urgent Medical Device Correction Letter (AX035/23/S).Letter states reason for recall, health risk and action to take.\n Siemens will correct the software error via Update Instruction AX036/23/S. With software version VA30K, the user interface of Cios VA30 systems will be changed to consider the current standards DIN 6862-3 and IEC 60601-2-54. \n\nOur 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.\n\nPlease review, understand, and confirm acknowledgement of the information and instructions outlined in this Customer Safety Advisory Notice. Please respond within 14 days of receiving this notification.\nIf you have received this notification by email via Adobe GigaSign, kindly sign with your digital signature to acknowledge that you have read and understand the content provided. If you have received this customer notification by delivery by the US Postal Service or by FedEx, please send an email to recallsandrefusals.team@siemens-healthineers.com acknowledging that you have read and understand the content provided.\n\nPlease ensure that all users of the affected products within your organization and others who may need to be informed will receive the relevant safety information provided within this notice and will comply with the recommendations therein.", "product_quantity": "237 units", "distribution_pattern": "Nationwide", "openfda": { "k_number": [ "K231700", "K130638", "K181830", "K133278", "K232298", "K010435", "K200074", "K151598", "K101833", "K220432", "K023178", "K010942", "K112180", "K923049", "K251602", "K243328", "K240199", "K162148", "K220409", "K081073", "K082243", "K171755", "K221922", "K172700", "K193326", "K211782", "K162614", "K123508", "K160088", "K234109", "K252099", "K212159", "K213768", "K132558", "K183109", "K251520", "K171565", 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