{ "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": "2026-08-13", "results": { "skip": 0, "limit": 1, "total": 1259 } }, "results": [ { "cfres_id": "130113", "product_res_number": "Z-0002-2015", "event_date_initiated": "2014-09-02", "event_date_posted": "2014-10-02", "recall_status": "Terminated", "event_date_terminated": "2015-02-24", "res_event_number": "69258", "product_code": "KPR", "k_numbers": [ "K133259" ], "product_description": "Siemens Ysio Max system\nThe Ysio Max is a radiographic system used in hospitals, clinics, and medical practices. Ysio Max enables radiographic and tomographic exposures of the whole body including: skull, chest, abdomen, and extremities and may be used on pediatric, adult and bariatric patients. It can also be used for intravenous, small interventions (like biopsy, punctures, etc.) and emergency (trauma, critical ill) applications. Exposures may be taken with the patient sitting, standing, or in the prone position. The Ysio Max system is not meant for mammography. The Ysio Max uses integrated or portable digital detectors for generating diagnostic images by converting x-rays into electronic signals. Ysio Max is also designed to be used with conventional film/screen or Computed Radiography (CR) cassettes.", "code_info": "Siemens Ysio Max material #s: 10762470, serial numbers: 24033 24028 24024 24034 24015 24026 24014 24016 24025 24037", "firm_fei_number": "2240869", "recalling_firm": "Siemens Medical Solutions USA, Inc", "address_1": "51 Valley Stream Pkwy", "city": "Malvern", "state": "PA", "postal_code": "19355", "additional_info_contact": "Customer Support\n610-219-6300", "reason_for_recall": "Two malfunctions posing potential risk to patients were identified with Siemens Ysio Max, AXIOM Luminos dRF Max, Uroskop Omnia Max, and Luminos Agile Max systems with a specific set of serial numbers that will cause lost images due to an automatic Radiology Information System (RIS) worklist update, thus causing examinations to be repeated. Image label may also be displayed incorrectly after images", "root_cause_description": "Software design", "action": "Siemens sent a Safety Advisory Notice, dated September 2, 2014, to all affected customers. The Notice identified the product, the problem, and the action to be taken by the customer. Customers were instructed to disable the automatic RIS worklist update and perform this procedure manually. Customers should disable the Measurement Field Display and Collimator Display by setting the display time for both setting to 0 sec (if editable). Customers should forward the safety notice to the new owner and inform Siemens of the new owner where possible. Customers with questions should call 610-219-2119 or 610-219-4834.\nFor questions regarding this recall call 610-219-6300.", "product_quantity": "10", "distribution_pattern": "Nationwide Distribution - US including UT, MO, CO, MA, MN, MS, OH, SC, MI, and NY.", "openfda": { "k_number": [ "K071402", "K071401", "K102349", "K800788", "K220149", "K013826", "K190330", "K213700", "K122454", "K803049", "K953832", "K180663", "K182183", "K063246", "K182880", "K082798", "K841756", "K790069", "K071546", "K970136", "K192364", "K022737", "K231761", "K172869", "K182517", "K790685", "K192541", "K936087", "K921112", "K110828", "K113248", "K853753", "K854110", "K083503", "K172229", "K790070", "K242499", "K210692", "K933778", "K093816", "K091889", "K233719", "K973219", "K203537", "K181629", "K102285", "K082261", "K122726", "K182134", "K972766", "K880982", "K870400", "K072659", "K180765", "K101686", "K133959", "K071392", "K872525", "K183541", "K191699", "K974112", "K913711", "K102408", "K253446", 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