{ "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": "189744", "product_res_number": "Z-0182-2022", "event_date_initiated": "2021-10-13", "event_date_created": "2021-10-28", "recall_status": "Open, Classified", "res_event_number": "88860", "product_code": "MUJ", "k_numbers": [ "K132816" ], "product_description": "Oncentra Brachy users using version 4.0 and above with Applicator Modeling license 170283-00", "code_info": "Oncentra Brachy users using version 4.0 and above with Applicator Modeling license 170283-00\n\nGTIN Numbers: 08717213052758, 08717213038660, 08717213020610, 08717213052321, 08717213052314, 08717213052307, 08717213052291, 08717213052246, 08717213052239,\n08717213051881, 08717213051843, 08717213051782, 08717213051775, 08717213051294, 08717213020610, 08717213053717, 08717213053700", "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": "770-670-2422", "reason_for_recall": "Under certain circumstances, there can be a difference between the planned and delivered dose of the two ovoid channels.", "root_cause_description": "Software design", "action": "An Urgent Important Field Safety Notification letter (FAC-NU-0007) was issued to consignees to notify of the issue, clinical impact and recommend the following:\n\n1) Recommended User Action in the unique scenario, which is only applicable for the Venezia\" applicator: Avoid use of the combination of the two Venezia\" applicator Anchor Points O1-Center and O2-Center by disabling one of them in the Applicator Library Manager.\n\n2)Recommended User Action in the exceptional situation that may also occur for other Applicator Models: Avoid incorrect placement of the Anchor Points, especially exchanging left / right anchor point positions.\n\n3) Recommended User Actions for both scenarios:\nUntil an updated version of Oncentra Brachy is available, it is strongly advised:\n\" To use additional Anchor Points during applicator modelling. This will further reduce the chance of\nmirroring the Applicator Model.\n\" To cross-check the source dwell position information from the Case Explorer to be in accordance\nwith the source dwell positions in the image views.\n\" Use the Triangles option for the applicator skin visualization in the 3D view, and review whether the\nApplicator Model has a correct shading display.\n\" Perform proper Quality Assurance for all treatment plans before treatment delivery.\n\n\nConsignees are required to acknowledge receipt of the notification to Elekta within 30 days.", "product_quantity": "1072 devices", "distribution_pattern": "Distribution throughout USA\n\nOUS distribution including:Algeria, Argentina, Australia, Austria Bahamas, Bangladesh, Belarus, Belgium, Bolivia, Botswana, Brazil Brunei, Bulgaria, Canada, Chile, China, Colombia, Croatia, Cyprus, Czech Republic, Denmark, Egypt, Estonia, Finland, France, Georgia, Germany, Ghana, Greece, Honduras, Hong Kong, Hungary, Iceland, India, Indonesia, Iran (Islamic Republic of), Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Korea, Republic of, Kosovo, Libyan Arab Jamahiriya, Malaysia, Mexico, Morocco, Netherlands, New Zealand, Norway, Pakistan, Peru, Philippines, Poland, Portugal, Republic of Serbia, Romania, Russian Federation, Saudi Arabia, Senegal, Singapore, Slovakia, South Africa, Spain, Sudan, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uzbekistan, Venezuela, Vietnam", "openfda": { "k_number": [ "K071873", "K180308", "K001295", "K161136", "K990475", "K031349", "K233236", "K013112", "K041997", "K112060", "K242992", "K993675", "K160093", "K181145", "K121448", "K130617", "K173940", "K172163", "K250963", "K090531", "K012017", "K203766", "K013535", "K062032", "K082221", "K152393", "K220582", "K080601", "K123152", "K002237", "K091179", "K201350", "K170355", "K090182", "K200487", "K123357", "K241318", "K252784", "K011246", "K992753", "K041719", 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"3014873236", "3005136058", "2916710" ], "device_name": "System, Planning, Radiation Therapy Treatment", "medical_specialty_description": "Radiology", "regulation_number": "892.5050", "device_class": "2" } } ] }