| TGA Action ID |
RC-2026-RN-00680-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
IntelePACS – InteleConnect Portal / Tech Portal Version
PACS-5-1-1-R102 PACS-5-2-1-R93 PPACS-5-3-1-R83 through R128 PACS-5-4-1-R66 through R101 PACS-5-5-1-R50 through R89 PACS-5-6-1-R41 through R81 PACS-5-7-1-R21 through R61 PACS-5-8-1-R2 through R42 PACS-5-9-1-R8 through R19 |
| ARTG Number |
149923 |
| Action Type |
Product Correction |
| Action Level |
Hospital |
| Hazard Classification |
Class I |
| Reason for the Action |
Following an update to Chromium-based web browsers, the Physician Portal Case Viewer may incorrectly display the report from a previously viewed examination alongside images from the currently selected examination. The report panel may fail to refresh when users navigate between examinations, resulting in a report that does not correspond to the displayed images while appearing under the same patient identifiers. This could result in misdiagnosis, delayed or incorrect patient treatment. The underlying report data remains correct and unaltered; the problem is limited to the display of report content within the report panel. |
| Instructions for Customers/Users |
While awaiting a software update, customers are to: - Use Firefox or Safari, or use a version of Google Chrome or Microsoft Edge earlier than version 152 when accessing the Physician Portal Case Viewer. - If Firefox, Safari, or an earlier browser version cannot be used, refresh the browser page each time an examination or study is opened to ensure the correct report is displayed. - Arrange for the correction with an Intelerad representative when contacted. |
| Action Commencement Date |
3/09/2026 |
| Responsible Entity |
|
| Contact Information |
AUNZVigilance@ul.com - Emergo Australia |