| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2015-RN-00599-1 |
| Product Name/Description |
ACUSON S1000, ACUSON S2000, or ACUSON S3000 Ultrasound Systems with software version VC30A, VC30B, VC30C, or VC31A
ARTG Number: 137563 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
3/07/2015 |
| Responsible Entity |
|
| Reason/Issue |
Siemens has recently discovered a potential miscalculation when using the Doppler manual trace measurement tool in a full screen display format. The manual trace tool may incorrectly calculate the Time Average Velocity (TAV) and subsequently incorrectly calculate the Pulsatility Index (PI). The potential risk is a misdiagnosis however, the probability is low. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
This issue will be resolved in a future software release. In the interim to avoid this issue, users are advised not to perform measurements utilising the manual Doppler trace tool in a full screen display format. This action has been closed-out on 15/02/2017. |
| Contact Information |
1800 310 300 - Technical Support Centre |