{ "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": "2026-09-17", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "199468", "product_res_number": "Z-1498-2023", "event_date_initiated": "2023-02-02", "event_date_posted": "2023-05-02", "recall_status": "Open, Classified", "res_event_number": "92046", "product_code": "OWB", "k_numbers": [ "K163286" ], "product_description": "ARTIS pheno systems with a Siemens Healthineers table or Trumpf/MAQUET table (OEM)-\nAngiography systems developed for single and biplane diagnostic imaging and interventional procedures.\nModel: 10849000", "code_info": "UDI: 04056869046877\n\nS/N:\nSerial #\n164140\n164159\n164138\n164332\n164331\n164033\n164287\n164282\n164210\n164184\n164183\n164311\n164142\n164312\n164071\n164328\n164034\n164391\n164318\n164244\n164306\n164155\n164340\n164189\n164277\n164173\n164292\n164231\n164095\n164057\n164055\n164054\n164329\n164072\n164190\n164048\n164025\n164026\n164027\n164338\n164094\n164241\n164326\n164267\n164186\n164068\n164121\n164157\n164019\n164152\n164161\n164013\n164069\n164213\n164073\n164293\n164263\n164298\n164060\n164083\n164113\n164021\n164066\n164398\n164362\n164124\n164125\n164366\n164279\n164075\n164098\n164028\n164153\n164330\n164389\n164394\n164172\n164086\n164084\n164074\n164295\n164353\n164234\n164321\n164242\n164275\n164270\n164315\n164344\n164163\n164158\n164053\n164171\n164297\n164134\n164253\n164333\n164188\n164377\n164403\n164063\n164064\n164397\n164300\n164299\n164105\n164160\n164024\n164080\n164049\n164240\n164359\n164227\n164228\n164018\n164022\n164250\n164061\n164187\n164115\n164399\n164011\n164211\n164216\n164204\n164205\n164212\n164100\n164097\n164269\n164303\n164322\n164355\n164400\n164196\n164352\n164168\n164319\n164201\n164202\n164371", "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, during the procedure, X-ray has been released and a reference image has been stored, the following issue may occur: If \"Adjust C-arm to Ref\" is activated when the C-Arm is positioned outside of the working range the C-Arm will reach the target position with an inaccuracy of 5-10 mm. As a result, the message Endposition reached will be displayed .Leading to unintended direction of the movement causing crushing of a patient, staff member, operator, or equipmen\n\nLive images may not match the previously stored reference images. Overlay images may be shown inaccurate on anatomy (e.g., DSA Roadmap workflow does not match real anatomy). This may cause e.g., a vessel perforation in DSA roadmap.", "root_cause_description": "Software design", "action": "Siemens Healthineers issued to all users of ARTIS pheno systems with a Siemens Healthineers table or Trumpf/MAQUET table (OEM) a Customer Safety Advisory Notice to affected customers via AX041/22/S dated 2/3/23. Letter states reason for recall, health risk and action to take for addressing three potential software issues: Detection of wrong table movement direction; Adjust C-arm to Ref; Missing movement stop with multiple collision sensor activation. Siemens will correct the software error via Update Instructions AX040/22/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. Please review, understand, and confirm acknowledgement of the information and instructions outlined in this Urgent Safety Advisory Notice.\n\nSiemens \n\nA software update to correct the error will be distributed to all affected customers via Update Instructions AX040/22/S. Affected systems will be updated to SW version VE10B.", "product_quantity": "141 units US", "distribution_pattern": "Worldwide - US Nationwide distribution.", "openfda": { "k_number": [ "K221516", "K243376", "K231669", "K222625", "K040675", "K150967", "K241572", "K210900", "K243328", "K153244", "K123226", "K130893", "K210912", "K152697", "K030544", "K252099", "K160455", "K183109", "K091918", "K172574", "K160147", "K101833", "K052202", "K123508", "K210307", "K936180", "K213479", "K240465", "K190626", "K073543", "K220342", "K243646", "K051064", "K061163", "K234067", "K011292", "K213768", "K010435", "K251523", "K170909", "K230950", "K141979", "K111551", "K232344", "K162614", "K193230", "K111344", "K120282", "K201743", "K041931", "K200022", "K240199", "K251199", "K101868", "K203623", "K220409", "K122644", "K031637", "K182546", "K221335", "K042793", "K121444", "K233107", "K142708", "K100102", "K022069", "K250282", "K103416", "K974355", "K093066", "K152696", "K983069", "K253726", "K181804", 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