| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2017-RN-00228-1 |
| Product Name/Description |
Artis Systems with software versions VC14, VC21, VD10, VD11 and VE10
(fluoroscopic angiographic digital x-ray system)
Catalogue Numbers: 10094135, 10094137, 10094139, 10094141, 10280959, 10848280, 10848281, 10848282, 10848283, 10848353, 10848355
ARTG Number: 273952 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
14/02/2017 |
| Responsible Entity |
|
| Reason/Issue |
Siemens has identified an issue with the current operating instructions. An existing system function is not fully described in the operating instructions, and this function may allow users to complete a treatment or diagnosis despite a defective focus.
For Artis systems with the specified software versions, a semi-automatic focus switch is implemented. Interacting with a special type of defect due to wear in the foci "small" and "micro" (if present), this performs an automatic focus switch when the footswitch is pressed several times. This special system function is not fully described in the operating instructions currently available. If a focus (small/micro) develops a defect, an alternative focus can be selected by pressing the footswitch several times. This enables radiation to be generated once again so that the clinical treatment or diagnosis can be continued. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Siemens is providing supplement to the operating instructions that describes the corresponding "system messages" for the existing system function and explains how to use the function properly in the event of a fault.
This action has been closed-out on 01/03/2018. |
| Contact Information |
1800 310 300 - Siemens Customer Care Centre |