| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2014-RN-00784-1 |
| Product Name/Description |
Brainlab Patient Data Manager
Product Version Number: 2.0
Sub Versions: 2.0.0, 2.0.1 & 2.0.2
ARTG Number: 96517 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
14/07/2014 |
| Responsible Entity |
|
| Reason/Issue |
Brainlab has identified two potential problems when loading image data that consists of non-square pixels with PDM 2.0.
1- Display of image data: When loading non-square pixel image data with PDM 2.0, the data set is not correctly transferred and displayed in the corresponding Brainlab navigation or planning software.
2- Dose calculation: It has been determined that non-square pixel data is not suitable for dose calculation with the current Brainlab iPlan RT systems. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
End users are advised to not load image data sets with non-square pixels if Brainlab Patient Data Manager version 2.0 (including subversions 2.0.0, 2.0.1 and 2.0.2) is installed at your hospital. Brainlab will provide a software update to affected customers to correct this issue. This action has been closed-out on 01/03/2016. |
| Contact Information |
02 9424 3800 - Brainlab Australia Pty Ltd |