Events

Safety Alert for BrainSCAN version 5.31 and 5.32

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
    2011-11-15
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20111116.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 version 5.31 and 5.32 medical device manufacturer, brainlab, has issued a field safety notice advising users of a potential undesirable effect that might occur with the pencil beam dose algorithm of brainscan version 5.31 or version 5.32 under specific conditions. the brainscan pencil beam dose algorithm may overestimate the dose delivered to the target region if both of the following conditions are met: the scatter measurements have been performed according to the technical reference guide (trg) “brainlab physics” (any revision), i.E. the scatter table was measured and implemented without values for equal jaw and mlc field sizes. and in the treatment plan, the margin between jaw position and mlc field shape is set to a value smaller than the default margin of 8mm in leaf movement direction and 2mm in direction perpendicular to leaf movement. as a consequence, a dose lower than planned and intended might be delivered to the patient, potentially resulting in ineffective treatment. according to the local supplier, the affected device has been distributed in hong kong. if you are in possession of the affected products, please contact supplier for necessary actions.

Device

BrainSCAN version 5.31 and 5.32
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Brainlab BrainSCAN version 5.31 and 5.32
  • Manufacturer
    Brainlab

Manufacturer

Brainlab