IntelePACS InteleViewer software version 4.11.1 P144 (Radiology picture archiving and communication system) 의 리콜

Recall

RC-2016-RN-00199-1

Class II

2016-02-25

Australia

DHTGA

https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00199-1

Since the introduction of a fix to the measurements algorithm (bz55214), inteleviewer now uses the ratio of the distance from the source to patient over distance from source to detector to compute a scaling factor to apply to measurements when the estimated radiographic magnification factor (dicom (0018,1114)) is not present. that scaling should only be applied when dealing with a projection radiography modality (cr, dx, mg, px, rf, or xa), however, it ended up being applied to other modalities, such as ct, generating erroneous measurements.This software defect could lead radiologists to base their diagnosis/report on wrong anatomical measurements. no patient incidents have been reported at this time.

Emergo is advising users to ensure that they uninstall the affected software version from their workstations and install an alternative version of lnteleViewer (e.g. IV 4-11-1 P143 or IV 4-11-1 P145). Also, users are advised to review the studies that were done with lnteleViewer 4-11-1 Pl44 and determine appropriate follow-up with patients. Users will be provided with the list of potentially affected studies.