{ "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": "2026-08-20", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "204260", "product_res_number": "Z-0517-2024", "event_date_initiated": "2023-10-17", "event_date_posted": "2023-12-08", "recall_status": "Open, Classified", "res_event_number": "93399", "product_code": "MUJ", "k_numbers": [ "K141900" ], "product_description": "SagiPlan 2.2, CE0344, Rx Only , Brachyterapy Treatment Planning System", "code_info": "SagiPlan, article # 1374-0600, version 2.2", "firm_fei_number": "1000310011", "recalling_firm": "Bebig Isotopentechnik Gmbh", "address_1": "Robert-Rossle-Str. 10 10 robert-rossle-str.", "city": "Berlin", "country": "Germany", "reason_for_recall": "Due to software malfunction, numerical values may be rounded resulting in inaccurate measurements.", "root_cause_description": "Software Design Change", "action": "On October 17, 2023, Eckert & Ziegler BEBIG GmbH issued a \"Urgent Field Safety Notice\" via email. Eckert & Ziegler asked consignees to take the following actions: \n\n1. If the Length Unit is set to millimeters, user must carefully review and, if necessary, adjust the Image Sequence Plane Separation value during import when working with slice thicknesses that have two decimals, as shown in Figure 1. Users must consider that this approach is not intrinsically safe, therefore solution 1 or 2 is highly recommended \n\n2. If you have used mm as length unit and may have used two decimal numbers in mm for slice thickness, carefully review the patient cases and act accordingly.\n\n3. This notice needs to be passed on to all those who need to be aware within your organization or to any organization where the devices have been transferred to.\nPlease reply to this email by 20th of October 2023 confirming that you have received and understood this information and that you have forwarded it to the people which already have received the named products or will receive them.", "product_quantity": "2 software licenses in US, 255 software licenses in OUS", "distribution_pattern": "US: MD\nOUS: Germany", "openfda": { "k_number": [ "K132971", "K091179", "K982696", "K915691", "K211379", "K232400", "K171885", "K201444", "K982791", "K252304", "K012017", "K242992", "K211034", "K142108", "K041403", "K011246", "K041719", "K100056", "K160093", "K983343", "K180379", "K123263", "K051497", "K022036", "K991815", "K211841", "K260308", "K042269", "K100417", "K220783", "K082221", "K051941", "K100552", "K002312", "K201607", "K223279", "K151666", "K032724", "K210645", "K984532", "K150547", 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