{ "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": "2026-09-05", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "132119", "product_res_number": "Z-0994-2015", "event_date_initiated": "2014-12-15", "event_date_posted": "2015-01-16", "recall_status": "Terminated", "event_date_terminated": "2017-01-26", "res_event_number": "70020", "product_code": "KPR", "k_numbers": [ "K062623", "K111292", "K133259" ], "product_description": "Ysio Max, Luminos dRF Max and Agile Max systems with software version VE10 and SmartOrtho license.\n\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": "Material 10762470 10762470 10762470 10762470 10762470 10762470 10762470 10762470 10762470 10762470 10762470  serial numbers24077 24051 24038 24059 24066 24015 24026 24058 24039 24090 24075", "firm_fei_number": "2240869", "recalling_firm": "Siemens Medical Solutions USA, Inc", "address_1": "51 Valley Stream Pkwy", "city": "Malvern", "state": "PA", "postal_code": "19355-1406", "additional_info_contact": "Customer Support\n610-219-6300", "reason_for_recall": "Potential for composed images to be flipped before being sent to PACS on systems with software version VE10 and SmartOrtho license. Flipped images may be reversed so the associated annotations, e.g. labels (R/L), may be displayed incorrectly, potentially leading to misdiagnosis.", "root_cause_description": "Software design", "action": "The firm, Siemens, sent a \"Safety Advisory Notice - XP080/14/S\" letter dated December 8, 2014, to end users that identified the product, problem, and actions to be taken. Siemens provided instructions to avoid the issue and indicated a software fix would be released as a permanent resolution. The customers were instructed observe this safety notice and comply with the corresponding measure until the update has been fully completed.\n\n\nIf you have any questions, contact the Regulatory Technical Specialist at 610-219-2119.", "product_quantity": "11", "distribution_pattern": "US Distribution to states of: ID, IL, MI, MN, MO, ND and PA.", "openfda": { "k_number": [ "K071401", "K223842", "K152788", "K811142", "K193637", "K220149", "K790069", "K233543", "K233920", "K242847", "K140683", "K173517", "K120752", "K123105", "K872468", "K771051", "K012389", "K101042", "K083109", "K812332", "K220919", "K071403", "K120034", "K023008", "K790070", "K150725", "K192541", "K860025", "K201725", "K121109", "K220271", "K192453", "K193089", "K103050", "K080655", "K223550", "K061595", "K161937", "K191879", "K811215", "K800788", "K162529", "K233662", "K173953", "K953832", "K150816", "K133959", "K790685", "K230800", "K981880", "K212186", "K913711", "K790741", "K140332", "K990298", "K941592", 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