| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2013-RN-00966-1 |
| Product Name/Description |
Artis Systems running Artis VC1x software (Fluoroscopic angiographic diagnostic x-ray system)
ARTG Number: 102177 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
13/09/2013 |
| Responsible Entity |
|
| Reason/Issue |
Under certain conditions, x-ray release on Artis system version VC1X may get blocked. The
potential malfunction may only occur if:
a) the system is ready for operation, and
b) the C-arm was moved into the so called "Patient Transfer Position" for patient transfer (in this position x-ray is blocked), and
c) at the same time the C-arm is in "Patient Transfer Position", a hardware failure in the IAS (Image Acquisition System) is occurring.
If the C-arm is moved out of the "Patient Transfer Position" (the problem with the IAS was solved by the system itself), X-ray remains blocked.
This issue is known to have only occurred on a single system in the field. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
If the failure mode occurs, customers are advised to urgently manually switch the system OFF ("System shutdown") then switch the system back ON again. The failure mode cannot be generally rectified by either executing the "System Restart" or "Application Restart" functions. The supplement to the Operator Manual with the above information is enclosed with the customer letters. The problem will be resolved during the next service update. |
| Contact Information |
1800 310 300 - Siemens Technical Support Centre |