| TGA Action ID |
RC-2026-RN-00757-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
IntelePACS
Affected Versions:
PACS-4-3-4-R20
PACS-4-9-1-R80
PACS-4-12-1-R81 through R90
PACS-4-14-1-R46 through R137
PACS-4-16-1-R50 through R137
PACS-4-17-1-R23 through R117
PACS-4-18-1-R31 through R91
PACS-5-1-1-R17 through R102
PACS-5-2-1-R36 through R93
PACS-5-3-1-R26 through R128
PACS-5-4-1-R15 through R101
PACS-5-5-1-R7 through R89
PACS-5-6-1-R12 through R81
PACS-5-7-1-R2 through R61
PACS-5-8-1-R2 through R42
PACS-5-9-1-R8 through R19 |
| ARTG Number |
149923 |
| Unique Device Identifier (UDI) |
B228INTELEPACS0 |
| Action Type |
Product Correction |
| Action Level |
Hospital |
| Hazard Classification |
Class II |
| Reason for the Action |
Intelerad has identified two software defects affecting certain versions of IntelePACS:
1. A security vulnerability within the InteleBrowser administration portal that could allow an authenticated administrator to execute arbitrary script content in another administrator's browser session. Exploitation could enable unauthorised modification or deletion of image or study data and disruption of legitimate user access.
2. A software defect within Image Object Change Management (IOCM) processing that could allow unintended deletion of image data from an external archive integration configured with a non-default deletion-source filtering override. If not detected, this image data deletion could result in delayed or incorrect patient treatment.
There have been no injuries or unauthorised access reported to Intelerad as a result of this problem. |
| Instructions for Customers/Users |
Customers are to continue to use the system by continuing to follow standard cybersecurity and access control practices until the correction is implemented.
An Emergo representative will contact customers to arrange for the correction. |
| Action Commencement Date |
1/10/2026 |
| Responsible Entity |
|
| Contact Information |
AUNZvigilance@ul.com - Emergo Australia |