Events

Recall of BRAINSCAN RADIOSURGERY SYSTEM - SOFTWARE

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by BRAINLAB AG.

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
    100491
  • Event Risk Class
    II
  • Event Initiated Date
    2016-01-08
  • Event Country
    Canada
  • Event Source
    HC
  • Notes / Alerts
    Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
  • Extra notes in the data
  • Reason
    The contours of anatomical structures outlined in brainlab smartbrush are displayed shifted when loaded in brain matestases. brainlab has identified a potential error when importing image sets and associated outlined objects into brain matestases version 1.0.0 or adaptive hybrid surgery analysis version 1.0.0.

Device

BRAINSCAN RADIOSURGERY SYSTEM - SOFTWARE
  • Model / Serial
    Model Catalog: 21703-01 (Lot serial: 1.0.0.); Model Catalog: 21703-02 (Lot serial: 1.0.0.); Model Catalog: 21702-04 (Lot serial: 1.0.0.)
  • Product Description
    BRAINSCAN RADIOSURGERY SYSTEM - SOFTWARE
  • Manufacturer
    BRAINLAB AG

Manufacturer

BRAINLAB AG
  • Manufacturer Address
    MUNICH
  • Manufacturer Parent Company (2017)
    Brainlab AG
  • Source
    HC