{ "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": "2026-08-22", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "142245", "product_res_number": "Z-0648-2016", "event_date_initiated": "2015-11-05", "event_date_created": "2016-01-14", "recall_status": "Terminated", "event_date_terminated": "2017-08-21", "res_event_number": "72804", "product_code": "MUJ", "k_numbers": [ "K142108" ], "product_description": "RT Elements are applications for radiation treatment planning for use in stereotactic, conformal, computer planned, Linac based radiation treatment of cranial, head and neck, and extracranial lesions. The simulated plan is intended for treatment evaluation for example in tumor board meetings or operating rooms", "code_info": "Adaptive Hybrid Surgery Analysis version 1.0.0  Model/catalogue number Description 21702-04 ELEMENTS AUT. BRAIN METASTASES PLAN INST 21703-01 ELEMENTS ADAPT HYB SURG ANALYSIS LICENSE 21703-02 ELEMENTS ADAPT HYB SURG ANALYSIS INST 21702 ELEMENTS AUTOMATIC BRAIN METS PLAN SUB 21702-12 ELEMENTS AUTOMATIC BRAIN METS PLAN SUB 21702-36 ELEMENTS AUTOMATIC BRAIN METS PLAN SUB 21702-60 ELEMENTS AUTOMATIC BRAIN METS PLAN SUB 21703 ELEMENTS AD-HYBRID SURG ANALYSIS SUBSCR 21703-12 ELEMENTS AD-HYBRID SURG ANALYSIS SUBSCR 21703-36 ELEMENTS AD-HYBRID SURG ANALYSIS SUBSCR 21703-60 ELEMENTS AD-HYBRID SURG ANALYSIS SUBSCR 21713 ELEMENTS ADAPTIVE HYBRID SURG. ANALYSIS 21722 ELEMENTS AUTO. BRAIN MET PLAN SUBS. FOC 21722-12 ELEMENTS AUTO. BRAIN MET PLAN SUBS. FOC 21722-36 ELEMENTS AUTO. BRAIN MET PLAN SUBS. FOC 21722-60 ELEMENTS AUTO. BRAIN MET PLAN SUBS. FOC 21723 ELEMENTS ADAPT HYB SURG ANALYS SUBS. FOC 21723-12 ELEMENTS ADAPT HYB SURG ANALYS SUBS. FOC 21723-36 ELEMENTS ADAPT HYB SURG ANALYS SUBS. FOC 21723-60 ELEMENTS ADAPT HYB SURG ANALYS SUBS. FOC 21732 ELEMENTS AUTOMATIC BRAIN METS PLAN. 12M", "firm_fei_number": "3002619595", "recalling_firm": "Brainlab AG", "address_1": "Kapellenstr. 12 12 kapellenstr.", "city": "Feldkirchen", "country": "Germany", "reason_for_recall": "Large objects with fine resolution are potentially displayed cropped when imported into Adaptive Hybrid Surgery Analysis version 1.0.0", "root_cause_description": "Software design", "action": "Brainlab sent a FIELD SAFETY NOTICE / PRODUCT NOTIFICATION letter dated November 5, 2015, to all direct accounts informing the of the recall and actions to be taken.\n\nUser Corrective Action:\nUsers of Brain Metastases Version 1.0.0 or Adaptive Hybrid Surgery Analysis 1.0.0 shall adhere to the following:\nAfter import always carefully review and verify all objects for correctness and validity.\nFor reviewing an object, select the image set which was used to outline or to modify the objects in the Data menu. Also compare the contours of an object in Brain Metastases or Adaptive Hybrid Surgery Analysis software to the contours in SmartBrush. \n\nPlease note that the error will not be visible in SmartBrush. Always verify the correct shape of the objects in Brain Metastases or Adaptive Hybrid Surgery Analysis software. If possible do not use image data sets with large slice distance and/or with a low amount of slices. To retrospectively identify if cropped objects have been used for treatment planning, the object contours of a specific treatment plan can be reviewed in Brainlab Dose Review, where the error will also be visible.\n\nBrainlab will provide a software update with this issue solved to affected customers. Brainlab will actively contact affected customers tentatively starting February 2016 to schedule the update. \n\nThe request that users advise the appropriate personnel working in their department of the content of the Notification letter. \n\nIf the user facilities require further clarification, thay can contact their local Brainlab Customer Support Representative. \n\nCustomer Hotline: +49 89 99 15 68 44 or +1 800 597 5911 (for US customers)\nE-mail: support@brainlab.com (for US customers: us.support@brainlab.com)\nFax: Brainlab AG: + 49 89 99 15 68 33", "product_quantity": "48 systems", "distribution_pattern": "Worldwide Distribution - US (nationwide) and Internationally to Australia, Belgium, Brazil, Canada, China, France, Germany, Hong Kong, Ireland, Israel, Italy, Japan, Mexico, Portugal, South Korea, Spain, Switzerland, Turkey and the United Kingdom.", "openfda": { "k_number": [ "K180308", "K170969", "K203469", "K231825", "K002132", "K994413", "K203766", "K201350", "K192065", 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