Events

Recall of Brainlab Patient Data Manager(Used for the display of medical images or treatment / surgery plans from picture archiving and communication systems (PACS), file servers, or removable storage media)

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Brainlab Australia Pty Ltd.

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
    RC-2015-RN-00960-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2015-09-29
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00960-1
  • Notes / Alerts
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • Extra notes in the data
  • Reason
    When actively deselecting a fused reference dataset in content manager (the default setting is “selected”), a contained point, object or trajectory may appear shifted and/or distorted in the subsequently used brainlab navigation or planning software. if a reference dataset is deselected and the error occurs, the magnitude of shift or distortion varies, depending on the differences between the two datasets. therefore, for some cases, the shift or distortion will be clearly visible when the plan is used in a brainlab planning or navigation system. however, a shift could also be non-obvious. if a shift or distortion occurred and was not detected during review of the data, the deviation of the information displayed in the brainlab planning or navigation software could mislead the user regarding clinical decisions. this could ultimately lead to ineffective treatment, serious injury or even death of the patient.
  • Action
    Brainlab will provide a software solution to prevent the described scenario from occurring starting February 2016. In the interim, users are advised not to deselect individual datasets where a Point, Object or Trajectory was planned in. If users are unsure in which dataset a Point, Object or Trajectory was planned, do not deselect any content from the plan. Open the entire plan instead. Before patient treatment, always review the plausibility of all information input to and output from the device.

Device

Brainlab Patient Data Manager(Used for the display of medical images or treatment / surgery plans...
  • Model / Serial
    Brainlab Patient Data Manager(Used for the display of medical images or treatment / surgery plans from picture archiving and communication systems (PACS), file servers, or removable storage media)Product Version NumbersContent Manager (versions 2.0.0, 2.0.1, 2.0.2, 2.0.3, 2.1.0) Patient Browser (versions 4.0.0, 4.0.1, 4.0.2, 4.0.3, 4.1.0) DICOM Viewer (versions 2.0.0, 2.0.1, 2.0.2, 2.0.3, 2.1.0) ARTG Number: 96517
  • Manufacturer
    Brainlab Australia Pty Ltd

Manufacturer

Brainlab Australia Pty Ltd