ACUSON S Family Ultrasound Systems with software versions VC25D, VC30A, VC30B 의 리콜

Recall

RC-2014-RN-00657-1

Class I

2014-06-23

Australia

DHTGA

https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00657-1

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.

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.