Events

Recall of Brain Metastases v1.0.0 and Adaptive Hybrid Surgery Analysis (AHSA) v1.0.0(Used for Linac based radiation treatment planning 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-2016-RN-00046-2
  • Event Risk Class
    Class I
  • Event Initiated Date
    2016-01-15
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00046-2
  • 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
    Brainlab image fusion is used for co-registration of medical images. when loading the fusion result in affected devices, under specific circumstances, the fusion result stored by image fusion is disregarded. instead the image datasets are co-registered based on the scanner-inherent fusion that can potentially result from acquiring the images in one imaging session. in consequence, the image datasets may become shifted e.G. organs at risk or planning target volume, may become shifted in relation to their anatomical position. while using brain metastases 1.0.0, if the shifted objects are 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. while using ahsa 1.0.0, the incorrect information displayed can have an effect on clinical decisions. in a worst case scenario, this can mislead the clinician in assessing the extent of tumour resection during surgery.
  • Action
    Brainlab will implement a software update for the affected systems. In the interim, users of affected systems are advised to adhere to the following: If possible do not use image datasets with an identical coordinate system (i.e. same frame of reference information), unless the scanner fusion is acceptable to be approved in Image Fusion. Always carefully review and verify the fusion result and all objects for correctness and validity in Brain Metastases or Adaptive Hybrid Surgery Analysis. Specifically if the error message is displayed by the software, review the position of all objects in the CT used for treatment planning and in the image datasets with the same frame of reference. Please note that the error will not be visible in SmartBrush, Image Fusion and DICOM Viewer. Always verify the fusion result and correct position of objects in Brain Metastases or Adaptive Hybrid Surgery Analysis.

Device

Brain Metastases v1.0.0 and Adaptive Hybrid Surgery Analysis (AHSA) v1.0.0(Used for Linac based r...
  • Model / Serial
    Brain Metastases v1.0.0 and Adaptive Hybrid Surgery Analysis (AHSA) v1.0.0(Used for Linac based radiation treatment planning of cranial, head and neck, and extracranial lesions)ARTG Number: 230067
  • Manufacturer
    Brainlab Australia Pty Ltd

Manufacturer

Brainlab Australia Pty Ltd