| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2015-RN-00720-1 |
| Product Name/Description |
ACUSON SC2000 ultrasound systems with software versions VA16A to VA30A and the Stress Echo Option
Catalogue/Lot number – 10433816 (ACUSON SC2000) with software versions VA16A to VA30A and 10436375 (2D Stress Echo Licence)
ARTG number: 139591 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
12/08/2015 |
| Responsible Entity |
|
| Reason/Issue |
When performing a 2D Stress Echo study, specific keystrokes may result in a potential loss of data, where some selected clips may not be saved as part of the study. The potential risk is that the stress echo study may need to be performed again. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Siemens is providing users with interim instructions to follow. A software update will be provided to affected users, which will resolve the issue. This action has been closed-out on 05/12/2016. |
| Contact Information |
1800 310 300 - Siemens Technical Support Centre |