| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2013-RN-00623-1 |
| Product Name/Description |
Biograph mCT systems running the VG40A or VG40B software
(Digital Imaging System) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
19/06/2013 |
| Responsible Entity |
|
| Reason/Issue |
This recall action is an update to RC-2013-RN-00357-1.Siemens has identified that Biograph mCT systems running software VG40A or VG40B can experience intermittent aborting of CT or PET/CT scans during an examination, in addition to intermittent CT planning and image reconstruction failures. These issue are due to software errors.
|
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Siemens is advising end users on how a check can be performed during the planning of the CT acquisitions and reconstructions, within a PET/CT protocol that could indicate that a problem is likely to occur. The problems will be addressed in the upcoming VG40C software release which is planned to be released within the next 2 months. |
| Contact Information |
1800 310 300 - Siemens Technical Assistance |