| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2013-RN-00687-1 |
| Product Name/Description |
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 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
4/07/2013 |
| Responsible Entity |
|
| Reason/Issue |
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. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
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. |
| Contact Information |
02 9424 3800 - Brainlab Australia |