| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2015-RN-00396-1 |
| Product Name/Description |
Brainlab Navigation Software Spine & Trauma 3D versions 2.0 /2.1 and Navigation Software Cranial / ENT version 2.1
ARTG Number: 96517 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
12/05/2015 |
| Responsible Entity |
|
| Reason/Issue |
Brainlab navigation software offers automatic registration of CT image data sets, intraoperatively acquired with an integrated NeuroLogica BodyTom portable CT scanner (“BodyTom”). In the course of clinical usage of these devices at different hospitals, registration inaccuracies have been identified in some instances when using automatic registration with BodyTom. In these cases the data set could not be accurately registered to the actual patient anatomy when performing automatic registration. An accurate registration (match between CT image data set virtually displayed in navigation and the current patient anatomy) is essential for a successful navigation.
If a potentially inappropriate registration is not detected during user verification, the deviation of the position information in the navigation software could mislead the user regarding clinical decisions. This could ultimately lead to ineffective treatment, serious injury or even death of the patient. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
To reduce the risk of an inappropriate automatic registration, Brainlab in cooperation with NeuroLogica has developed an improved integration and verification workflow to be followed by users which is provided with the customer letter.
Brainlab will individually contact each affected customer to offer:
a) a service visit to assist in the selection and marking of a suitable movement path and to perform the calibration and verification in cooperation with Neurologica.
b) an additional training regarding the improved verification methods. This action has been closed-out on 08/08/2016. |
| Contact Information |
02 9424 3800 - Brainlab Australia |