Events

Safety Alert for Brain Metastases v1.0.0 and Adaptive Hybrid Surgery Analysis v1.0.0

According to Department of Health, this safety alert involved a device in Hong Kong that was produced by Brainlab.

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Date
    2015-12-01
  • Event Date Posted
    2015-12-01
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20151201.html
  • Notes / Alerts
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 data from the U.S. and Hong Kong.
  • Extra notes in the data
    Medical Device Safety Alert
  • Reason
    Medical device safety alert: brainlab brain metastases v1.0.0 and adaptive hybrid surgery analysis v1.0.0 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.

Device

Brain Metastases v1.0.0 and Adaptive Hybrid Surgery Analysis v1.0.0
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Brainlab Brain Metastases v1.0.0 and Adaptive Hybrid Surgery Analysis v1.0.0
  • Manufacturer
    Brainlab

Manufacturer

Brainlab