{ "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": "2026-09-10", "results": { "skip": 0, "limit": 1, "total": 2 } }, "results": [ { "cfres_id": "217903", "product_res_number": "Z-1339-2026", "event_date_initiated": "2025-12-12", "event_date_posted": "2026-02-10", "recall_status": "Open, Classified", "res_event_number": "98212", "product_code": "MUJ", "k_numbers": [ "K151666" ], "product_description": "Brand Name: Leksell GammaPlan\nProduct Name: Radionuclide RT Treatment planning system\nSoftware Version: 11.1\nProduct Description: Leksell GammaPlan is a computer-based system designed for Leksell Gamma Knife treatment planning.", "code_info": "Lot Code: 07340048311236 (LGP 11.1)", "firm_fei_number": "1037831", "recalling_firm": "Elekta, Inc.", "address_1": "400 Perimeter Center Ter NE Ste 50 400 Perimeter Center Ter NE", "address_2": "Ste 50", "city": "Atlanta", "state": "GA", "postal_code": "30346-1227", "additional_info_contact": "Elekta Care Support\n001-855-6935358", "reason_for_recall": "Due to an error when defining a new stereotactic reference that users fail to first change an already defined obsolete reference to a pre-plan reference. This may result in a treatment plan that potentially irradiates the incorrect patient location if the error is not detected by users.", "root_cause_description": "Use error", "action": "On 12/12/2025, the firm sent an \"IMPORTANT FIELD SAFETY NOTIFICATION/URGENT: MEDICAL DEVICE CORRECTION\" letter via email to customers informing them that when Defining a new stereotactic reference in an examination for a frame treatment while failing to first change an already defined obsolete stereotactic reference (representing a non-current frame fitting) to a pre-plan reference, may result in a treatment plan that irradiates the wrong patient location if the resulting inconsistent alignment between the stereotactic references is not detected by the user.\n\nCustomers are instructed to:\nIf the stereotactic reference for a frame treatment must be changed prior to plan approval (e.g. due to a change of frame fitting), make sure to first change the already defined obsolete stereotactic reference to a pre-plan reference before defining the new stereotactic reference. By so doing, the treatment examination is automatically updated according to the new stereotactic reference when it is defined.\nDo not combine the use of a stereotactic CBCT reference with other stereotactic references for treatments with a frame. This specific recommendation for CBCT is motivated by the increased likelihood of failure for users to detect an inconsistent stereotactic CBCT reference relative to other stereotactic references, compared to MR and CT image studies, which are typically displayed and explored throughout the planning process.\n\nPost this notice in a place accessible to all users, e.g. Instructions for Use, until this action is closed.\n\" Advise the appropriate personnel, working with this product, on the content of this letter.\n\nFor Questions - Contact Elekta Care Support at 855-693-5358 or email Application.Support.NA@elekta.com", "distribution_pattern": "Worldwide - U.S. Nationwide distribution including in the states of AK, AZ, CA, CO, ST, FL, GA, HI, IA, IL, LA, MA, MI, MN. MO, NC, NJ, NM, NY, OH, OK, OR, PA, PR, SC, SD, TN, TX, UT, VA, WA, WI, and WV. The countries of Algeria, Argentina, Australia, Belarus, Belgium, Brazil, Bulgaria, Canada, China, Colombia, Croatia, Czech Republic, Dominican Republic, Ecuador, Egypt, El Salvador, France, Georgia, Germany, Hong Kong, India, Iran, Iraq, Italy, Japan, Jordan, Republic of Korea, Kuwait, Libyan Arab Jamahiriya, Lithuania, Malaysia, Mexico, Morocco, Netherlands, Norway, Pakistan, Peru, Poland, Romania, Russian Federation, Saudi Arabia, South Africa, Spain, Sweden, Taiwan, Thailand, Turkey, United Kingdom, and Vietnam.", "openfda": { "k_number": [ "K151233", "K193640", "K182665", "K202284", "K260207", "K083264", "K242378", "K082005", "K992434", "K990475", "K974770", "K190178", "K990071", "K151435", "K170969", "K192554", "K234068", "K062967", "K202789", "K233236", "K211841", "K090972", "K181145", "K211379", "K071938", "K252784", "K223279", "K143269", "K022411", "K240671", "K022036", "K151380", "K040474", "K020027", "K091145", "K051497", "K100092", "K013112", "K111311", "K141900", 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"3004526608", "3003793371" ], "device_name": "System, Planning, Radiation Therapy Treatment", "medical_specialty_description": "Radiology", "regulation_number": "892.5050", "device_class": "2" } } ] }