| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2016-RN-01637-1 |
| Product Name/Description |
Artis zee, Artis Q and Artis Q.zen systems with software version VD11B
Catalogue/Lot Numbers: 10848281, 10848355, 10848282, 10848280, 10094139, 10094137, 10848353
ARTG Number: 273952 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
20/12/2016 |
| Responsible Entity |
|
| Reason/Issue |
During regular field observations Siemens have identified a software issue with two possible, mutually independent causes of a system defect, these are as follows:
1. In Artis systems with A100Plus or A100G 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; and
2. For biplane systems delivered with software version VD11B since April of this year, software problems in conjunction with the graphics card may in rare cases result in the loss of image display in the examination room.
Siemens advises they do not consider it necessary to re-examine any patients in this case and that this is a possible hardware defect that has no influence on the treatment of patients.
A system software update will implement additional protective mechanisms for the generator and correct the software problem. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Siemens will be contacting affected users to arrange a date to perform a system software update, which will implement additional protective mechanisms for the generator and correct the software problem. |
| Contact Information |
1300 310 300 - Siemens Customer Care Centre |