| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2015-RN-00816-1 |
| Product Name/Description |
ACUSON SC2000 ultrasound systems with software versions VB10B and lower
Lot number: 10433816
ARTG number: 139591 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
31/08/2015 |
| Responsible Entity |
|
| Reason/Issue |
The ACUSON SC2000 ultrasound system considers uppercase/lowercase differences in the same patient name as unique patient instances when registered on the same ultrasound system. The system recalls the case sensitivity even if the original study has been removed from the hard drive. If these differences are not corrected at the time of registration, the system does not capture images or clips.
The potential risk is the study data, including measurements, may not be captured and the study will need to be re-performed. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Siemens is providing work around instructions to follow as an interim measure. A software upgrade will be provided as a permanent solution. This action has been closed-out on 18/04/2017. |
| Contact Information |
1800 310 300 Technical Support Centre |