| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2013-RN-01266-1 |
| Product Name/Description |
BrainLab Navigation Software Spine and Trauma 3D 2.0 (intra-operative image guided stereotactic localisation system to enable precision spine and trauma surgeries)
ARTG Number: 96517 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
28/11/2013 |
| Responsible Entity |
|
| Reason/Issue |
In the ‘fluoro match registration’ function when used in combination with a digitally integrated C-arm, the software algorithm may not find an adequate match between the intraoperatively acquired 2D fluoroscopic images and the preoperative CT or other compatible 3D datasets. Due to a software anomaly the intraoperative 2D fluoroscopic images are not correctly processed, causing a low contrast of the images potentially resulting in the software algorithm being unable to find a correct match between the low contrast 2D fluoroscopic images and the segmented area of the 3D dataset. Alternatively, it may incorrectly match the segmented area to the Spine Reference X-clamp. For an incorrect match, the display of instruments by the navigation system would be shifted compared to the actual patient anatomy. If this is not detected during user verification, deviation of position information could impact clinical decisions which could lead to ineffective treatment, serious injury or patient death. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Brainlab will provide a software update to affected customers with this issue resolved. As a temporary solution, until the software update has been implemented, users of the Navigation Software Spine & Trauma 3D 2.0 are advised to adhere to the workaround instructions in the customer letter. This action has been closed-out on 01/02/2016. |
| Contact Information |
02 9424 3800 - Brainlab Australia |