| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2014-RN-00657-1 |
| Product Name/Description |
ACUSON S Family Ultrasound Systems with software versions VC25D, VC30A, VC30B
ARTG Number: 137563 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
23/06/2014 |
| Responsible Entity |
|
| Reason/Issue |
A potential measurement error may occur in all exams (except Cardiac) when using the Auto-Stats tool or the Velocity tool during live imaging and when adjusting one of the following parameters with the Auto-Stats tool enabled:
- Changing the transmit frequency of the active transducer using the PW MultiHz control.
- Adjusting the position of the spectral baseline using the Baseline control.
- Adjusting the Pulsed Repetition Frequency (PRF) using the Scale control.
During system freeze, the measured results indicate the scale values prior to adjustment of any of the above parameters. As a result, the measurements and/or calculations will be incorrect. To date, no patient injury has been reported as a result of this issue. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Siemens is advising operators that the issue can be avoided by not using the Auto-Stats tool and to only use the Velocity tool on frozen images. A Siemens service engineer will be in contact to update to software to correct the issue. Users are advised that a look back at previously reported results should be considered at the discretion of the clinician. Thia action has been closed-out on 28/01/2016. |
| Contact Information |
1800 310 300 - Siemens Technical Support Centre |