Events

Recall of iPlan RT Dose / iPlan RT Versions 4.5.3 and 4.5.4, when used in combination with the optional function Dose Planning for Agility Multileaf-Collimator (MLC)

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Brainlab Australia Pty Ltd.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    RC-2016-RN-01317-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2016-10-07
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-01317-1
  • Notes / Alerts
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
  • Extra notes in the data
  • Reason
    The agility mlc controller automatically adds a physical gap of 1mm (about 3mm projected to the isocenter) between opposing closed leaf pairs. therefore, leakage radiation through this gap must be correctly considered during treatment planning and dose calculation. due to a software inconsistency, the brainlab pencil beam dose calculation algorithm does not correctly regard and represent this gap if all of the following conditions are met:1. iplan rt dose v. 4.5.3 or 4.5.4 is used.2. the planning option for agility mlc is used for a treatment plan.3. the machine profile (dose profile entered in the brainlab treatment planning software) for the used agility mlc and linear accelerator combination contains a leaf shift static value different than 0mm.If the above described conditions are met, only specific plans irradiating multiple separate target volumes simultaneously with a single isocenter are affected.
  • Action
    Users are advised to immediately check the Leaf Shift Static value in all the machine profiles in iPlan RT Dose for an Agility MLC: Ensure that this value is set to “0 mm”. If another value is found, please change this specific value to 0 in order to permanently resolve the described potential issue. The users are also reminded of the following information which is in the current IFU: - For any new or changed machine profiles, it is highly recommended to perform a dose verification (using a phantom) before clinical use, to ensure adequate implementation and accuracy of dose calculation. - Patient-specific Quality Assurance of a treatment plan and verifying the dose distribution (in a suitable phantom) is highly recommended before irradiating the patient. Brainlab will be offering a software solution and will contact affected customers starting November 2017 to implement the update free of charge.

Device

iPlan RT Dose / iPlan RT Versions 4.5.3 and 4.5.4, when used in combination with the optional fun...
  • Model / Serial
    iPlan RT Dose / iPlan RT Versions 4.5.3 and 4.5.4, when used in combination with the optional function Dose Planning for Agility Multileaf-Collimator (MLC)ARTG Number: 121114
  • Manufacturer
    Brainlab Australia Pty Ltd

Manufacturer

Brainlab Australia Pty Ltd