Events

Recall of iPlan CMF 3.0, iPlan Cranial 3.0, iPlan ENT 3.0, iPlan Flow 3.0, iPlan spine 3.0, iPlan Stereotaxy 3.0 (including all subversions)

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-00687-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2013-07-04
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00687-1
  • 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 exporting a treatment plan created with brainlab iplan 3.0 for usage with brainlab navigation software, planned objects may be shown cropped, boundaries shaped differently or the objects may appear larger or smaller if all of the following conditions are met:1. the plan is exported to one of the following navigation software (standard brainlab format is used):-vectorvision cranial/ent ver. 7.X; -kolibri cranial/ent ver. 2.X; -cranial/ent essential/unlimited ver. 1.X; -vectorvision spine ver. 5.5.1; -vectorvision spine ver. 5.6.2. one or more slices of the image set (or any of the image sets fused to it) exceeds a coordinate of +511mm or -511mm, and the contours of the planned object extend into those slices.3. the standard export settings have been changed: the feature "enable interpolation for non-512x512 images" is disabled.
  • Action
    Brainlab are providing users with work around instructions to mitigate the risks as an interim measure. A software update will be provided in users when available to permanently correct the issue. This action has been closed-out on 28/01/2016.

Device

iPlan CMF 3.0, iPlan Cranial 3.0, iPlan ENT 3.0, iPlan Flow 3.0, iPlan spine 3.0, iPlan Stereotax...
  • Model / Serial
    iPlan CMF 3.0, iPlan Cranial 3.0, iPlan ENT 3.0, iPlan Flow 3.0, iPlan spine 3.0, iPlan Stereotaxy 3.0 (including all subversions)ARTG Number: 96517
  • Manufacturer
    Brainlab Australia Pty Ltd

Manufacturer

Brainlab Australia Pty Ltd