The Therapeutic Goods Administration (TGA) of Australia has posted a medical device safety alert concerning the Brainlab Brain Metastases v1.0.0 and Adaptive Hybrid Surgery Analysis v1.0.0 manufactured by Brainlab.
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 Metastases v1.0.0 or Adaptive Hybrid Surgery Analysis v1.0.0.
For the Brain Metastases v1.0.0, 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 v1.0.0, 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.
The manufacturer will provide a software update with this issue solved. In the interim, users are advised to implement the workarounds instruction provided by the manufacturer.
For details, please refer to the TGA website:
http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2015-RN-01164-1
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 1 December 2015