{ "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": 2 } }, "results": [ { "cfres_id": "218008", "product_res_number": "Z-1174-2026", "event_date_initiated": "2025-12-29", "event_date_posted": "2026-01-27", "recall_status": "Open, Classified", "res_event_number": "98244", "product_code": "OWB", "k_numbers": [ "K250660" ], "product_description": "Interventional Fluoroscopic X-Ray System: LUMINOS Q.namix R;\nSiemens Material Number (SMN): 11574002;\nWith Software Version VB10D-SP02", "code_info": "Siemens Material Number (SMN): 11574002;\nUDI-DI: 04056869993973;\nSerial Numbers: 150050, 150035, 150033, 150034, 150048, 150021, 150020, 150053, 150023, 150044, 150049, 150037, 150054, 150011, 150059, 150024, 150038, 150051, 150029, 150045, 150032, 150056, 150043, 150055, 150041, 150026, 150025, 150022, 150031, 150039, 150046, 150042, 150028, 150047, 150030, 150052, 150027, 150057, 150040, 150058, 150063;", "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": "Rebecca Tudor\n484-323-4198", "reason_for_recall": "Ortho images acquired with preset automatic horizontal flip are not flipped and when acquiring single images, there is the possibility that an image of a previous patient may be processed.", "root_cause_description": "Software design", "action": "On December 29, 2025 URGENT: MEDICAL DEVICE CORRECTION letters were sent to customers. \nActions to be taken:\nIssue 1: Ortho images acquired with preset automatic horizontal flip are not flipped: For ortho examinations, no clinical protocols should be used where the automatic horizontal flip function is active.\nIssue 2: When acquiring single images, there is the possibility that an image of a previous patient may be processed:\na. When acquiring single images with the Dynamic X.fluoro detector, the above-mentioned error\nmessage should be observed, and the system should be restarted when it appears.\nb. Images planned at the Bucky Wall Stand should be acquired on the basic unit or with a mobile\ndetector.\nShould a single image on the Bucky Wall Stand in horizontal orientation be inevitable, the system must be restarted beforehand.\nHow will the problem be resolved?\nSiemens Healthineers is preparing a software update to resolve the described problems. The new software version VB10E will be distributed via Update Instruction XP031/25/S during the first quarter of 2026 free of charge.\nOur service organization will contact you to arrange a date to perform this corrective action. Please feel free to contact our service organization at 1-800-888-7436 for an earlier appointment.", "product_quantity": "41 units", "distribution_pattern": "Worldwide - US Nationwide distribution in the states of AK, CA, IL, MN, NY, OR, VA, WI and the countries of Austria, Belgium, Denmark, France, Germany, Greece, Ireland, Italy, Netherlands, Norway, South Africa, Spain, Sweden, Switzerland.", "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", 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