| TGA Action ID |
RC-2025-RN-00449-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
Biograph Horizon systems with previously replaced MAS2 board
Product Code: 10532748 |
| ARTG Number |
271560 |
| Action Type |
Product Correction |
| Action Level |
Hospital |
| Hazard Classification |
Class III |
| Reason for the Action |
The Biograph Horizon PET/CT imaging system may not be following the IEC (International Electronic Commission) standard 60601-1 which states that when an e-stop is initiated, the patient handling system (PHS) must stop abruptly (within 25 mm of its current position). Instead of stopping abruptly, the system may move several additional millimetres more than the 25 mm allotted by the IEC standards.
The overall risk of this additional movement is minimal to both the patient and clinical staff. No adverse events have been reported for this problem. |
| Instructions for Customers/Users |
Users are to be aware that when initiating an e-stop, the system may move several additional millimetres prior to coming to a full stop.
An update to the system will correct this problem and bring it into compliance with IEC 60601-1. Customers will be contacted by Siemens to schedule a service visit to perform the correction. Expected completion of the update is Q1 2026.
This action has been finalised on 11/9/2025. |
| Action Commencement Date |
13/05/2025 |
| Responsible Entity |
|
| Contact Information |
1800 310 300 - Siemens Customer Care Centre |