| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2013-RN-01350-1 |
| Product Name/Description |
Artis systems running software version VC21B in conjunction with a Large Display
ARTG Number: 102177 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
20/12/2013 |
| Responsible Entity |
|
| Reason/Issue |
If the system is not turned “OFF” manually at regular intervals an automatic reset of the Large Display Controller can occur. During the reset the system switches for approximately 1-2 minutes into the “Bypass Fluoro” mode. During this time only the native fluoroscopic image is displayed. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Siemens is advising operators of the Artis system to ensure that the system is manually turned off at regular intervals. A software update will be implemented to correct the problem. |
| Contact Information |
1800 310 300 - Siemens Technical Support Centre |