| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2018-RN-00115-1 |
| Product Name/Description |
ACUSON SC2000 ultrasound systems with software versions VB10A, VB10B, VB10D, VB10E that have PRIME and eSie PISA software licenses
Catalogue Number: 10433816
ARTG Number: 139591 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
6/02/2018 |
| Responsible Entity |
|
| Reason/Issue |
The 3D eSie PISA volume analysis application quantifies valvular regurgitation. While imaging with the Z6Ms volume transesophageal echocardiography transducer, this application may underestimate the EROA (Effective Regurgitant Orifice Area) in comparison to the same patient results obtained with the 4Z1c volume transthoracic echocardiography transducer.
There is a low risk of misdiagnosis occurring from underestimating the patient's mitral regurgitation severity when using the eSie PISA analysis application with the Z6Ms volume transesophageal echocardiography transducer. |
| Recall Action |
Product Defect Correction |
| Recall Action Instructions |
Siemens is advising that users should continue to rely on a combination of several quantitative parameters for evaluation of mitral regurgitation rather than solely on the EROA derived from eSie PISA analysis with the Z6Ms transducer.
This action has been closed out on the 08/11/2018. |
| Contact Information |
1800 310 300 - Siemens Customer Care Centre |