| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2016-RN-00375-1 |
| Product Name/Description |
Artis zee Systems with generator A100Plus or Artis zeego Systems with software version VC21B. (fluoroscopic angiographic x-ray systems)
Catalogue/Lot numbers: 10280959, 10094139, 10094135, 10094137, 10094141
ARTG Number: 102177 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
31/03/2016 |
| Responsible Entity |
|
| Reason/Issue |
The manufacturer, through post market surveillance, has identified the following problems with the affected devices:
a) In Artis zeego systems, angulations in the vicinity of the C-arm collision area can cause the cable inlet to become clamped and can result in mechanical damage.
b) In Artis systems with A100Plus generators, an attempt to resume operation following detection of a fault (such as a short circuit in the X-ray tube) can result in the failure of a module in the high-voltage generator, which can lead to system non-availability.
The reported issues can cause an ongoing procedure to be terminated. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Siemens service organisation will contact the affected customers to arrange for the installation of a software update, which will eliminate the reported problems.
This action has been closed out on the 12/10/2018. |
| Contact Information |
1800 310 300 - Siemens Technical Support Centre |