{ "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": "189037", "product_res_number": "Z-2445-2021", "event_date_initiated": "2021-08-16", "event_date_posted": "2021-09-10", "recall_status": "Open, Classified", "res_event_number": "88588", "product_code": "MUJ", "k_numbers": [ "K211379" ], "product_description": "syngo.via RT Image Suite with syngo.via VB30, VB40, VB50 and VB60-\n Intended for Radiation Therapy Treatment\nMaterial Number: 10496180", "code_info": "Serial Numbers:\n100713\n223736\n222946\n223440\n223032\n223347\n223084\n223811\n130643\n223004\n451078\n101724\n132011\n131247\n451036\n132231\n451032\n222835\n130848\n500010\n101773\n132729\n130874\n133176\n100421\n100419\n100420\n100643\n100642\n100811\n100814\n100644\n102369\n100812\n100641\n100418\n100813\n100645\n131284\n130712\n223734\n102305\n132893\n223310\n222411\n223258\n223334\n223090\n132781\n131867\n222563\n222417\n222491\n131503\n130125\n451070\n222224\n132108\n500013\n132061\n131169\n451023\n451017\n451077\n132701\n102113\n451094\n130628\n500007\n131213\n131360\n500020\n500028\n451079\n132205\n451031\n451001\n222914\n130331\n451034\n133191\n102108\n132136\n131325\n222686\n223207\n130734\n102021\n131578\n500005\n451071\n222521\n132904\n102031\n222539\n222860\n451039\n130335\n222862\n222638\n100677\n222729\n131336\n223188\n130452\n223220\n131801\n131589\n222719\n132102\n130140\n223844\n500004\n451074\n451030\n133198\n222601\n133261\n132595\n130751\n223150\n131966\n223424\n223259\n223058\n131012\n\n***Updated 12/9/21***\n223021\n\n***Updated 1/31/22:\nSerial number\n222475\n133503", "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": "Potential for data loss when using the contouring or patient marking workflow when editing a structure set after saving and reopening a study, resulting in an incomplete structure set sent to the treatment planning system (TPS).", "root_cause_description": "Software design", "action": "Siemens has initiated three (3) Customer Safety Advisory Notices (CSANs) to affected customers via SY052/21/S, CT042/21/S and MR019/21/S by email or hand delivery by the Siemens Customer Service Engineer on 8/16/21. Temporary workarounds are available for some of the software versions and are described in the CSANs. Additionally,\na solution to eliminate the root cause of this problem is being distributed via SY051/21/S (for SY and CT) and MR021/21/S for MR to all affected customers free of charge.\nThe service organization will contact you to arrange a date to perform this corrective action free of charge. Contact the service organization for an earlier appointment at 1-800-888-7436.\n***UPDATE: 01/31/22\nAdditionally, a solution to eliminate the root cause of this problem is being distributed via CT049/21S, CT061/21/S, CT062/21/S, and CT088/21/S for CT.\n***UPDATE: 03/12/22\nStatus Report Additional 13 S/N's added", "product_quantity": "126 units", "distribution_pattern": "US Nationwide distribution.", "openfda": { "k_number": [ "K000922", "K022036", "K120551", "K252863", "K211034", "K041719", "K915691", "K232400", "K220582", "K202284", "K170750", "K253050", "K011246", "K080601", "K991237", "K063482", "K141283", "K223279", "K091492", "K110730", "K151666", "K062514", "K141900", "K083414", "K113102", "K090808", "K151369", "K082642", "K223724", "K022741", "K083264", "K260308", "K091179", "K093588", "K234068", "K181145", "K260750", "K990475", "K031088", "K071760", "K111311", "K220141", "K013535", "K102915", "K201350", "K062032", "K022411", "K082221", "K080929", "K002237", "K133331", 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"medical_specialty_description": "Radiology", "regulation_number": "892.5050", "device_class": "2" } } ] }