| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2012-RN-01165-1 |
| Product Name/Description |
Artis Zeego Systems (Fluoroscopic diagnostic x-ray system for angiographic procedures) with SW revision VC14, VC20 & VC21 in conjunction with a specific technical configuration
ARTG Number: 102177 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
30/11/2012 |
| Responsible Entity |
|
| Reason/Issue |
In the course of Siemens' product monitoring activities, a potential risk for patient or operators was determined during the operation of an Artis Zeego System with SW revision VC14, VC20 & VC21 in conjunction with a specific technical configuration which cannot be completely excluded. In case of an unlikely failure of brake, the C-arm may descent.
This recall action was undertaken by Siemens Ltd before it was agreed with the TGA. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
All the affected systems were checked by Siemens technical engineer for the potential for the failure mode to occur. |
| Contact Information |
1800 310 300 - Siemens Regulatory Affairs |