| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2013-RN-00076-1 |
| Product Name/Description |
Artis Zee/Zeego Systems equipped with A 100 plus generator (Fluoroscopic angiographic digital x-ray system)
System Material numbers: 10094135, 10094137, 10094139, 10094141, 10094142, 10094143, 10280959
Generator Material number: 10563420
ARTG Number: 102177 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
12/02/2013 |
| Responsible Entity |
|
| Reason/Issue |
Siemens has determined that the A 100 plus generator may fail during operation when equipped with the Artis Zee/Zeego system. The generator fails due to a tolerance problem in the power supply of the generator control. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Siemens will be fitting affected systems with a modified board assembly which is able to cover larger tolerance deviations |
| Contact Information |
1800 310 300 - Siemens Regulatory Affairs |