Events

Recall of Brainlab Brain Metastases v1.0.0 and Adaptive Hybrid Surgery Analysis v1.0.0(Picture archiving and communication system (PACS) used in stereotactic, conformal, computer planned, Linac based radiation treatment of cranial, head and neck, and extracranial lesions)

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-2015-RN-01164-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2015-11-27
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-01164-1
  • 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
    Under very specific circumstances, there is the potential for large objects with fine resolution to be displayed cropped when imported from smartbrush into brainlab brain metastases1.0.0 or adaptive hybrid surgery analysis 1.0.0 for the brain metastases 1.0.0, if the cropped object is not recognised by the user before the plan is used for treatment and the deviation exceeds clinically acceptable limits, this could result in ineffective radiation treatment, serious patient injury, or even death of the patient. structures that are cropped in brain metastases are also cropped in the exported dicom rt structure set files. for the adaptive hybrid surgery analysis 1.0.0, if determination regarding the potential for radiotherapy is made, the incorrect information displayed can have an effect on clinical decisions. if the determination is done during surgery this could even, in a worst case scenario, mislead the user in regards to assessing the extent of resection during this surgery.
  • Action
    Brainlab will provide a software update with this issue solved to affected customers. Brainlab will actively contact affected customers starting February 2016 to schedule the update. In the interim, users are advised to implement the following workarounds: After import always carefully review and verify all objects for correctness and validity. 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. This action has been closed-out on 26/08/2016.

Device

Brainlab Brain Metastases v1.0.0 and Adaptive Hybrid Surgery Analysis v1.0.0(Picture archiving an...
  • Model / Serial
    Brainlab Brain Metastases v1.0.0 and Adaptive Hybrid Surgery Analysis v1.0.0(Picture archiving and communication system (PACS) used in stereotactic, conformal, computer planned, Linac based radiation treatment of cranial, head and neck, and extracranial lesions)ARTG Number: 230067
  • Manufacturer
    Brainlab Australia Pty Ltd

Manufacturer

Brainlab Australia Pty Ltd