| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2016-RN-00924-1 |
| Product Name/Description |
Artis Systems with 19" Live Display
(fluoroscopic angiographic x-ray system)
Reference Number: DSHC1914-DC
Part Number: 10656055
ARTG Number: 273952 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
11/07/2016 |
| Responsible Entity |
|
| Reason/Issue |
Due to an error in the 19" Live Display, image reproduction may fail in the examination room. The loss of image can only occur immediately after system start-up. This failure does not occur during normal operation or when the live image is displayed. Only systems which use a Live Display (reference DSHC1914-DC with part number 10656055) in the examination room are affected. Live Displays with other part numbers are not affected by this issue. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Siemens is advising users that the system can continue to be used. A firmware upgrade will be implemented as a permanent correction.
This action has been closed out on the 12/10/2018. |
| Contact Information |
1800 310 300 - Siemens Customer Care Centre |