{ "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": "2026-09-12", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "192270", "product_res_number": "Z-0841-2022", "event_date_initiated": "2022-01-31", "event_date_created": "2022-03-30", "recall_status": "Open, Classified", "res_event_number": "89703", "product_code": "KPR", "k_numbers": [ "K081722" ], "product_description": "Ysiosystem with VC10 software version, Model Number 10281013. Radiographic system", "code_info": "Serial Numbers: 20113\n23071\n20118\n22523\n23021\n22169\n23164\n22388\n22119\n22844\n21209\n23699\n21114\n22190\n22146\n22126\n22128\n22836\n22163\n22727\n22135\n22347\n21174\n22676\n22029\n22895\n22917\n22920\n22058\n22847\n22852\n22655\n22708\n22275\n22254\n22928\n22857\n22208\n22071\n23130\n22092\n22175\n21194\n23602\n23018\n23019\n22076\n22630\n21108\n22919\n22825\n22054\n22177\n20105\n22998\n20115\n22104\n22966\n23625\n23627\n22748\n22352\n22353\n22354\n22618\n21004\n21005\n22136\n23059\n22914", "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": "Anastasia Sokolova\n610-219-4834", "reason_for_recall": "Siemens Healthineers has identified a software error in previous software version VB10 for the Ysio fully automated system. The unit may process incorrect internal values for the position of its ceiling tube stand. If the user activates a longitudinal or transversal movement at the time of the error, the system controls may initiate a correction of the tube stand position, resulting in an unintended movement. If the described error occurs, a potential for collision risk for objects or persons in the vicinity of the moving stand exists. This may result in minor to serious injuries to persons.", "root_cause_description": "Software design", "action": "An URGENT: MEDICAL DEVICE CORRECTION dated 1/31/22 was sent to customers.\n\nWhat is the impact on system operation and what are the potential risks?\nIf the described error occurs, a potential for collision risk for objects or persons in the vicinity of the moving stand exists. This may result in minor to serious injuries to persons.\n\nWhat steps can the user take to avoid the potential risks associated with this issue?\nIt is highly improbably that the user will experience the described issue. However, it is recommended to follow regular cautions and instructions listed in the system operator manual, particularly in the chapter Safety , section Information about unit movements . Users and all accompanying personnel are advised to remain outside the zone of potential device movement, e.g., potential movement area of longitudinal and transversal direction of the ceiling stand.\n\nHow will the corrective action be implemented and how effective is the corrective action?\nSiemens Healthineers is distributing a Customer Safety Advisory Letter XP046/20/S to all affected customers. A field software update for Ysio units that will eliminate the described issue will be distributed via an Update Instruction XP045/20/S. Apart from the described correction, the updated software contains further stability, usability, and performance improvements.\n\nThis resolution will be provided free of charge and is planned to be available in the first quarter of calendar year 2022. Your local Siemens Healthineers Service organization will contact you as soon as the software update is available for your system. Please feel free to contact our service organization for an earlier appointment at 1-800- 888-7436. Following the corrective action, the cause is eliminated and any recurrence of this potential fault is prevented\n\nAcknowledge Receipt of this Safety Advisory Notice\nPlease review, understand, and confirm acknowledgement of the information and instructions outlined in this Urgent Safety Advisor", "product_quantity": "70 Systems", "distribution_pattern": "US Nationwide.", "openfda": { "k_number": [ "K061595", "K870400", "K071409", "K242847", "K841923", "K012546", "K163410", "K153119", "K193360", "K001341", "K122726", "K980296", "K872317", "K912515", "K163203", "K900562", "K050704", "K872316", "K231892", "K113855", "K110849", "K033577", "K221853", "K935649", "K212186", "K121513", "K150725", "K922813", "K253446", "K063246", "K242478", "K102680", "K001336", "K043025", "K141381", "K214012", "K150816", "K232178", "K942792", "K132934", "K233722", "K933512", "K160997", "K813173", "K163115", "K990715", "K944613", "K071392", "K040995", "K180543", "K941931", "K202293", "K770060", "K182622", 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