Events

Recall of Frameless SRS QA Target Pointer (Component of Brainlab Stereotactic System used for patient positioning during stereotactic radiosurgery or radiotherapy procedures using a linear accelerator)

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-2013-RN-00716-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2013-07-17
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00716-1
  • 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
    It has been detected that the pointer cap with the engraved cross hairs may become loose even when only a moderate force is applied to the pointer cap. due to the manufacturing tolerances specified the force to loosen the pointer cap may vary, depending on the individual pointer cap and aluminium pointer rod assembly. if this occurs, most likely the pointer cap will detach completely, rendering the target pointer no longer usable. in a scenario that the pointer cap would loosen but not detach completely, a shift of the pointer cap of up to 2mm might remain unnoticed. since the device is used for calibration and quality assurance of patient positioning technologies for radiation therapy treatments at a linear accelerator, this scenario might degrade the accuracy of the positioning solution used.
  • Action
    Brainlab is requesting users to inspect stock and quarantine affected devices. Replacement stock will be provided to affected customers.

Device

Frameless SRS QA Target Pointer (Component of Brainlab Stereotactic System used for patient posit...
  • Model / Serial
    Frameless SRS QA Target Pointer (Component of Brainlab Stereotactic System used for patient positioning during stereotactic radiosurgery or radiotherapy procedures using a linear accelerator)Product Number: 43410Serial Number: 1223012002, 1223012007, 1223012008ARTG Number: 121226
  • Product Classification
    Radiology Devices
  • Manufacturer
    Brainlab Australia Pty Ltd

Manufacturer

Brainlab Australia Pty Ltd