| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2016-RN-01474-1 |
| Product Name/Description |
AXIOM Artis systems with s/w version VB35E and Megalix X-Ray tubes
ARTG Number: 102177 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
10/11/2016 |
| Responsible Entity |
|
| Reason/Issue |
For AXIOM Artis systems with software version VB35E and Megalix X-Ray tubes, the semi-automatic focus switch may in cases of a type of defect in foci "small" and "micro" (if present), does not work as intended when pressing the footswitch multiple times. This focus defect, that causes the failure of the semi-automated focus switch, becomes more likely as the service life of the X-Ray tube increases.
This can result in the spontaneous malfunction of the active (micro or small) focal spot and a loss of imaging. While the manufacturer is not aware of any patient injuries, under the above circumstances this issue can cause a loss of the fluoroscopy functionality and may lead to a situation where the clinical procedure has to be aborted, rescheduled or the patient needs to be relocated to a functioning system. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
A software update will correct the above mentioned issue. After the update, the Artis system will switch again semi-automatically to a functioning focal spot for all focus defects, enabling images to be displayed until the current procedure comes to an end.
Users are advised that:
- For system operation with a 2-foci Megalix X-Ray tube, it is still possible to perform image acquisition with the large focus after manual selection of a corresponding organ program.
- For system operation with a 2-foci Megalix X-Ray tube, It is still possible to perform image acquisition with the large focus after manual selection of a corresponding organ program.
- There should be standard emergency procedures in place in case of system failures.
This action has been closed-out on 20/03/2018. |
| Contact Information |
1800 310 300 - Siemens Customer Care Centre |