| TGA Action ID |
RC-2026-RN-00217-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
YSIO X.pree with software version VA20G and X.wi-D detectors
Product Code: 11574001 |
| ARTG Number |
440731 |
| Action Type |
Product Correction |
| Action Level |
Hospital |
| Hazard Classification |
Class III |
| Reason for the Action |
Siemens Healthineers have identified a potential malfunction when using X.wi-D detectors in combination with software version VA20G on the YSIO X.pree system. In rare cases and under specific acquisition conditions involving X.wi-D detectors, the system may become unresponsive, most commonly during patient examinations that include free exposures.
A system restart is required to restore operations. In some cases, the image acquired immediately before the system freeze may not be recoverable, resulting in an image loss and the necessity to repeat the exposure. Image acquisitions with MAX wi-D detectors are not affected by this problem. |
| Instructions for Customers/Users |
Customers are to:
- Review the instructions provided in the Customer Letter.
- Until the correction is available, it is recommended to perform image acquisitions with the detector in the Bucky tray whenever this is clinically appropriate, instead of acquiring free exposures with X.wi-D detectors. Where available, use a MAX wi-D detector instead of the X.wi-D detector for free exposures.
The manufacturer is preparing a software update (VA20H) for the YSIO X.pree system that will resolve this problem. The update is planned to be available Q3 2026. |
| Action Commencement Date |
24/03/2026 |
| Responsible Entity |
|
| Contact Information |
1800 310 300 - Siemens Customer Care Centre |