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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 Siemens Ltd
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