BEUDAMED
    FDA Recall Open, Classified

    Oncentra Brachy users using version 4.0 and above with Applicator Modeling license 170283-00

    Recall: Z-0182-2022 · Initiated October 13, 2021

    Recall

    Recall Number
    Z-0182-2022
    Event Number
    88860
    Firm
    Elekta, Inc.
    FEI Number
    1037831
    Product Code
    MUJ
    Status
    Open, Classified
    Root Cause
    Software design
    Initiated
    October 13, 2021
    Address
    400 Perimeter Center Ter NE, Ste 50, Atlanta, GA, 30346-1227

    Description

    Oncentra Brachy users using version 4.0 and above with Applicator Modeling license 170283-00

    Reason

    Under certain circumstances, there can be a difference between the planned and delivered dose of the two ovoid channels.

    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: 1) 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. 2)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. 3) Recommended User Actions for both scenarios: Until an updated version of Oncentra Brachy is available, it is strongly advised: " To use additional Anchor Points during applicator modelling. This will further reduce the chance of mirroring the Applicator Model. " To cross-check the source dwell position information from the Case Explorer to be in accordance with the source dwell positions in the image views. " Use the Triangles option for the applicator skin visualization in the 3D view, and review whether the Applicator Model has a correct shading display. " Perform proper Quality Assurance for all treatment plans before treatment delivery. Consignees are required to acknowledge receipt of the notification to Elekta within 30 days.

    Distribution

    Distribution throughout USA OUS 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

    Quantity

    1072 devices