| TGA Action ID |
RC-2025-RN-00915-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
IntelePACS – InteleConnect / TechPortal
Versions: PACS-5-6-1-R64 through R68, PACS-5-7-1-R42 through R47, PACS-5-8-1-R20 through R23, PACS-5-9-1-R1 through R3 |
| ARTG Number |
149923 |
| Action Type |
Product Correction |
| Action Level |
Hospital |
| Hazard Classification |
Class II |
| Reason for the Action |
Emergo has identified a problem with the InteleConnect/TechPortal contained in IntelePACS software versions PACS-5-6-1-R64 to R68, PACS-5-7-1-R42 to R47, PACS 5-8-1-R20 to R23, and PACS-5-9-1-R1 to R3. The defect identified could result in the unintended loss of pre-existing data in the 'Relevant Clinical Info' field when modifying studies through the Case Editor in either the Technologist Portal or Referring Physician Portal.
This problem could result in the permanent loss of relevant clinical information that was previously entered, potentially impacting clinical decision-making, and posing a risk to patient safety.
There have been no reports of adverse reactions or other indications of injuries or diseases related to this problem. |
| Instructions for Customers/Users |
Emergo will contact consignees with further instructions on how to obtain the upgrade. Until the update is applied, staff members are to implement the interim mitigation as highlighted in the Customer Letter.
This action has been closed out on 17/02/2026 |
| Action Commencement Date |
23/10/2025 |
| Responsible Entity |
|
| Contact Information |
02 9006 1662 - Emergo Australia |