| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2014-RN-01243-1 |
| Product Name/Description |
Biograph mCT and Biograph mCT Flow systems running VG50A software and equipped with the Adaptive 3D Intervention option
Software version: VG50A
ARTG number: 144218 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
21/11/2014 |
| Responsible Entity |
|
| Reason/Issue |
Siemens has identified a potential malfunction that may cause a display freeze during CT interventional procedures. The user interface may lock-up when performing an Adaptive 3D Interventional procedure when the "Auto save at last displayed images as key images" is enabled.
When the issue occurs, normal interaction with the system is no longer possible and no error messages are displayed. Therefore the end-user and/or interventionalist may not know that the system has stopped interacting and continue wiht the interventional procedure. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Siemens is advising their customers to reconfigure the system Storage to deactivate "Auto save at last displayed images as key images". A software update will be implemented to correct the problem. This action has been closed-out on 18/03/2016. |
| Contact Information |
1800 310 300 - Siemens Technical Support Centre |