| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2024-RN-00457-1 |
| Product Name/Description |
ARTIS icono systems with small detector and the according collimator
Product Codes: 11327700 and 11328100
ARTG 273952
(Siemens Healthcare Pty Ltd - X-ray system, diagnostic, fluoroscopic, angiographic, stationary, digital) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
4/06/2024 |
| Responsible Entity |
|
| Reason/Issue |
In very rare situations, the first x-ray release after patient registration might be performed with a wrong copper prefiltration. After an acquisition or significant changes in the projection or angulation the problem will automatically be resolved. |
| Recall Action |
Product Defect Correction |
| Recall Action Instructions |
Until the software release to correct the problem is available, the manufacturer recommends taking any action, which lead to a change of the prefiltration, prior to the first x-ray release after a patient registration. This could be the first acquisition, the change of the organ program or changed water values due to steeper angulation.
Siemens will contact customers for an appointment to perform the correction when the update is made available. |
| Contact Information |
1800 310 300 - Siemens Customer Care Centre |