Events

Safety Alert for BrainSCAN and iPlan RT treatment planning software versions

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

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
    2012-03-20
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20120320a.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
    Field safety notice: brainlab brainscan and iplan rt treatment planning software versions medical device manufacturer, brainlab ag, has issued a field safety notice concerning all brainlab brainscan and iplan rt treatment planning software versions. according to brainlab, the accuracy of the brainlab radiotherapy treatment planning software was not within clinically desirable limits for very small multi-leaf-collimator field sizes. if not recognized by the user with the recommended treatment plan quality assurance, the irradiation of such a treatment plan might lead to serious injury of the patient and/or ineffective treatment. brainlab is notifying affected customers with a field safety notice and will provide an updated instructions for use to them. the tentative availability of the update will be in june 2012. according to the local supplier, the affected devices were distributed to hong kong. if you are in possession of the products, please contact your supplier for necessary actions.

Device

BrainSCAN and iPlan RT treatment planning software versions
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Brainlab BrainSCAN and iPlan RT treatment planning software versions
  • Manufacturer
    Brainlab AG

Manufacturer

Brainlab AG