| TGA Action ID |
RC-2026-RN-00849-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
Horizon-WI Dual-Energy X-ray Absorptiometry (DXA) System
Model number: Horizon-WI |
| ARTG Number |
400491 |
| Unique Device Identifier (UDI) |
15420045505865 |
| Action Type |
Product Correction |
| Action Level |
Hospital |
| Hazard Classification |
Class II |
| Reason for the Action |
The Horizon WI systems manufactured from 11 December 2024 to 16 January 2025 were shipped without the validated VGA cables. Some installations were completed using VGA cables that may not meet Hologic’s applicable performance and safety standards for this system.
The impacted units may present a potential risk of elevated Electromagnetic Interference (EMI) to users and/or patients near the affected Horizon DXA systems. The impact can range from user dissatisfaction to delay in treatment and presents an elevated risk of interference to the population of individuals with active, implantable medical devices.
As of October 1, 2026, Hologic has received 24 complaints from field engineers pertaining to this problem, with no reports of patient or user injury. |
| Instructions for Customers/Users |
A Hologic field service representative will contact affected customers to schedule an appointment to remediate the system with an Hologic-approved, compliant VGA cable.
In the interim, Hologic advises that customers can use the device, however users and patients with active implantable medical devices should refrain from operation or use of these devices until after remediation has been completed. |
| Action Commencement Date |
21/10/2026 |
| Responsible Entity |
|
| Contact Information |
02 9888 8000 - Hologic Customer Service |