| TGA Action ID |
RC-2025-RN-00922-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
Catalyst HD, Catalyst+ HD
Model Number: SP003-0002, SP001-0026, all versions with SRS license |
| ARTG Number |
266989 |
| Unique Device Identifier (UDI) |
UDI-DI: 17350005280779 , UDI-PI: 07350005280024 |
| Action Type |
Product Correction |
| Action Level |
Hospital |
| Hazard Classification |
Class I |
| Reason for the Action |
Gamma Gurus have identified a problem affecting the cSRS mode of the Catalyst+ HD and Catalyst HD systems. The stated precision of the Catalyst system for stereotactic radiosurgery (SRS) treatments cannot be guaranteed for all couch angles and system setups. In certain cases, the system may indicate the patient as correctly positioned at the isocentre, even when the isocentre is positioned outside of the indicated tolerance. This could result in erroneous dose delivery in the worst-case scenario.
This problem can only occur if the cSRS mode is used in combination with the cMotion module and the patient is incorrectly positioned, or the patient moves during treatment delivery. The problem is most prominent at non-coplanar couch positions.
No adverse events have been reported to date. |
| Instructions for Customers/Users |
a) Users are advised to not use Catalyst HD or Catalyst+ HD in combination with cSRS and cMotion until this problem is resolved or other actions have been taken. Please note, cMotion can continue to be used without cSRS active.
b) Ensure that all the staff operating the Catalyst+ HD and Catalyst HD, and the c4D software application are informed of this information.
c) The manufacturer C-RAD will release a new version of the software application c4D resolving this problem and/or update to IFU/labelling. |
| Action Commencement Date |
28/10/2025 |
| Responsible Entity |
|
| Contact Information |
02 9520 1966 - Gamma Gurus |