{ "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": 1 } }, "results": [ { "cfres_id": "189947", "product_res_number": "Z-0284-2022", "event_date_initiated": "2021-08-30", "event_date_created": "2021-11-24", "recall_status": "Terminated", "event_date_terminated": "2024-01-16", "res_event_number": "88888", "product_code": "JAK", "k_numbers": [ "K190578" ], "product_description": "SOMATOM Definition AS with software syngo.CT VB20\nModel #8098027", "code_info": "Serial Numbers:\nSerial Number 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"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": "software syngo.CT VB20 in the installed base, with or without syngo.CT software versions VB20_SP1, SP2, SP3, or SP4, may result in workflow interruptions\nresulting in the delay in diagnosis, the necessity for patient rescans, and/or the need for additional contrast media may occur", "root_cause_description": "Software design", "action": "Siemens Medical Solutions USA, Inc. initiated a Customer Safety Advisory Notice (CSAN) to customers via CT021/21/S on 8/30/2021. The CSAN informs the customer of the issues health risk, the new software update version VB20_SP5 to eliminate the root causes of these problems. The software update will be distributed free of charge via CT020/21/S and CT071/21/S (update is dependent on the current software version) to all affected customers. \nAction to take:\nSiemens Healthineers has developed software update syngo.CT VB20 SP5. This new software contains workflow improvements and solutions to the previously described software issues. Please ask your local service organization if you are interested in more detailed information about the content of the software update.\nThe new software, VB20_SP5, will be provided free of charge and will be distributed via Update CT020/21/S or CT071/20/S. Update CT071/20/S is only necessary if the system is being updated from software version VB20, VB20_SP1, or VB20_SP2 directly to VB20_SP5. Following the corrective action process CAPA, the cause of identified\nproduct issues has been eliminated and a recurrence of the identified issues is prevented.\nThis update will be performed remotely. The remote software updates process will require approximately 45 minutes for completion and is completely automatic; however, please make sure the system and power are stable before and during the process, please do not switch off the system during the update process. Siemens highly recommends\nstarting the installation when the scanner will not be in use or when the necessary time for the update to be completed can be scheduled.\nIf you have any questions, please contact our service organization at at 1-800-888-7436.\n\nPlease review, understand, and confirm acknowledgement of the information and instructions outlined in this\nUrgent Safety Advisory Notice. By signing this document, you are acknowledging that you have read and understand the content therein", "product_quantity": "665 units", "distribution_pattern": "US Nationwide distribution.", "openfda": { "k_number": [ "K903763", "K233657", "K020913", "K183161", "K041542", "K011141", "K242403", "K050297", "K073373", "K082960", "K884669", "K042229", "K991553", "K220450", "K012238", "K150565", "K151833", "K192427", "K912752", "K960635", "K210760", "K772289", "K112989", "K173632", "K894269", "K153263", "K121827", "K153429", "K961464", "K991278", "K020385", "K171183", "K233583", "K033774", "K250970", "K843927", "K213944", "K232155", "K160611", "K072737", "K173468", "K192590", "K030450", "K133640", "K151414", "K923111", "K010042", "K203216", "K200498", "K811227", "K113548", "K241440", "K180225", "K193454", "K250766", "K151673", "K972879", "K110066", "K994431", "K123576", "K253520", "K923110", "K133705", "K081482", "K980176", "K061449", "K163528", "K122106", "K120579", "K160587", "K080624", 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