| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2015-RN-00595-1 |
| Product Name/Description |
Acuson S2000 and Acuson S3000 Ultrasound Systems with the Virtual Touch IQ option
ARTG Number: 137563 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
3/07/2015 |
| Responsible Entity |
|
| Reason/Issue |
Siemens Healthcare received complaints that when repositioning the Virtual Touch IQ region of interest from the original (default) location, the lateral position of the measurement tool may not align with the lateral position of the shear velocity data. The maximum error in position between the measurement tool and shear velocity data is 3.8 mm.
The issue of concern is a potential underestimation of maximum shear wave velocity of a lesion. This underestimation may lead to a user deciding not to biopsy a cancerous lesion. The potential risk of misdiagnosis associated with this issue is low. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Siemens Healthcare is requesting the customers not reposition the Virtual Touch IQ region of interest from the original (default) location. Siemens is also requesting the customers to review previously performed studies to ensure the results are as expected. This issue will be resolved in a future software release.
This action has been closed-out on 01/03/2018. |
| Contact Information |
1800 310 300 - Siemens Technical Support |