| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2018-RN-00126-1 |
| Product Name/Description |
Biograph Horizon with VJ20A Software
Catalogue Number: 10532746 and 10532748
ARTG Number: 271560
(Siemens Healthcare Pty Ltd - Combination diagnostic imaging system, PET/CT) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
8/02/2018 |
| Responsible Entity |
|
| Reason/Issue |
Siemens Healthineers has become aware of an issue with the PET Quality Control software that introduces an error into the PET normalisation file. As a result there may be minimal visual and quantitative impacts to the PET images acquired and reconstructed with PETsyngo VJ20A software. |
| Recall Action |
Product Defect Correction |
| Recall Action Instructions |
Siemens will be in contact with affected customers to arrange for a software update to be installed.
In the event that users have any concerns about data that has been previously acquired and reconstructed prior to correction, users may refer to the Customer Letter for instructions for reconstructing data with a new normalisation file.
This action has been closed out on the 26/11/2018. |
| Contact Information |
1800 310 300 - Siemens Customer Care Centre |