| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2014-RN-00563-1 |
| Product Name/Description |
ACUSON S2000 and ACUSON S3000 Ultrasound Systems (software version VC25) or with HELX Evolution (software version VC30A)
Catalogue numbers: 10041461, 10440017 and 10441730
ARTG Number: 137563 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
29/05/2014 |
| Responsible Entity |
|
| Reason/Issue |
When using the 9L4 transducer in combination with Virtual Touch Quantification (VTq), the displayed Mechanical Index (ie, the Ml value which reflects the risk of mechanical cavitation that could cause tissue damage) may be outside the stated tolerance of +/=15%. This occurs only between the depths of 2.5cm and 3.4cm. To date, no patient injury has been reported. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Users are advised that the MI values should be interpreted as relative information and used only to assist the operators in implementing the ALARA (As Low As Reasonably Achievable) principle during patient examinations. For systems with software version VC25, Siemens is updating the Instructions for Use regarding the tolerance of the Mechanical Index (MI) displayed values. For systems with software version VC30A, Siemens is updating the software. This action has been closed-out on 18/02/2016. |
| Contact Information |
1800 310 300 - Siemens Technical Support |