Philips Brilliance iCT/iCT SP with software version 4.1.3, 4.1.5 의 리콜

Recall

RC-2016-RN-00680-1

Class II

2016-05-26

Australia

DHTGA

https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00680-1

Philips healthcare became aware of certain issues with the affected products through testing & customer feedback. the identified issues include;- imr cardiac - irregular appearance of contrast in vessels;- missing image annotations in cct- halo artefacts- incorrect z annotation on plan box for coronal/sagittal surviews- post injection delay between timed scans may be inaccurate- unintended change of acquisition timing on scan ruler- bolus tracker does not trigger as expected- cardiac step & shoot stops after arrhythmia detected- tracker scan halted with fdom- error when auto roi placement outside patient anatomy- no "go" when hr outside acceptable range- unplanned results during multi-phase pulmo series, may cause a system crash- dynamic myocardial perfusion acquisition halted after 1st shot- double clicking ecg phase bar crashes exam application- incorrect phase tolerance for cardiac s&s; &- ring artefacts on high resolution images, idose4 & imr.

Philips is providing work around instructions for users to follow as an interim measure. A software upgrade will be implemented as a permanent correction. This action has been closed-out on 24/05/2017.