| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2013-RN-01077-1 |
| Product Name/Description |
GSI Viewer, prior to version 2.00-0M on AW and prior to version 2.20-0B in AW Server (Picture archiving and communication system, PACS)
ARTG Number: 161257 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
17/10/2013 |
| Responsible Entity |
|
| Reason/Issue |
The GSI Viewer application running on AW/Volume Share or on the AW Server when making a batch and rotating the batch group clockwise 180 degrees (Inferior to Superior) will display images in the Superior orientation. The orientation annotation on the image is correct. The concern is that the patient right/left representation is from the Superior view, which could result in a misreading of the image and misdiagnosis. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
GE Healthcare is advising users that the orientation annotation is correct on the image, and to always correlate any information in any 3D reconstruction with the original data. GE Healthcare advises that a software correction will be installed on all affected systems by March 2014. |
| Contact Information |
1800 659 465 - GE Healthcare National Call Centre |