| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2014-RN-00539-1 |
| Product Name/Description |
ACUSON SC2000 Ultrasound Systems with Software Version 3.5 (VA35)
Catalogue Number: 10433816
ARTG Number: 139591 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
13/05/2014 |
| Responsible Entity |
|
| Reason/Issue |
The following issues may occur with cardiovascular studies after upgrading from software version 2.0 or 3.0 to software version 3.5 and restoring user-defined presets. This applies to all transducers except the 9L4 and 6C1 HD transducers:
- The system may incorrectly display the colour flow data in the wrong position. The potential risk to the patient is misdiagnosis based on erroneous color flow data.
The following issue may occur with software version 3.5:
- When you adjust the Doppler frequency, the system does not restart the pulsed wave Doppler or continuous wave Doppler waveform. However, the system displays previous Doppler data using the new Doppler scale which may result in inaccurate measurement values. The potential risk to the patient is misdiagnosis based on the same Doppler profile providing two different velocity measurement values. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Siemens is advising their customers to use factory default presets with software version 3.5 instead of user defined presets restored from software version 2.0 or 3.0. After adjusting the Doppler frequency, freeze and un-freeze the system to refresh the display of the Doppler spectrum resulting in the correct measurements. Siemens will be replacing the software of all affected devices. Thia action has been closed-out on 28/01/2016 |
| Contact Information |
1800 310 300 - Siemens Technical Support Centre |