ACUSON SC2000 Ultrasound Systems with software version 3.5 (VA35) 의 리콜

Recall

RC-2014-RN-00486-1

Class II

2014-04-29

Australia

DHTGA

https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00486-1

The following issues may occur when using the stress echo feature:- shorter-than-expected clips may occur when using systolic-only captures with heart rates at approximately 120bpm (beats per minute) and higher. this computational error may occur at any heart rate; but the system produces a smaller error for lower heart rates. the issue may also cause the system to change from systolic-only captures to full beat (r-r).- intermittently, some post-exercise clips may not be captured during continuous capture acquisition. - post-exercise clips marked for deletion (unselected clips) may be restored to the study after cycling power to the system. the potential risk to the patient may be a repeated stress echo study.

A software update will be provided to correct this problem. End users are advised to avoid the potential risks associated with this issue by: - Discontinue use of the stress echo feature with software version 3.5 - For studies acquired with the systolic only captures, review all patient studies on exams performed after the software revision 3.5 was installed.