| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2015-RN-00818-1 |
| Product Name/Description |
Cios Alpha mobile C-arm x-ray system
Catalogue/Lot number – 10308191
ARTG Number: 102180 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
28/08/2015 |
| Responsible Entity |
|
| Reason/Issue |
Siemens have received reports that under certain circumstances, when starting the system up or reconnecting the C-arm cable to the main unit, the error 5000/243 “No X-ray - FD re-initialises” may occur. The error refers to a potential hardware malfunction of the Cios Alpha C-arm x-ray system that may occur when starting the system up or reconnecting the C-arm cable to the main unit. When this occurs, the system will become inoperable until the affected part is replaced. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Siemens is planning to release a modification for the Cios Alpha mobile C-arm x-ray system that will resolve the above-mentioned potential malfunction. As soon as the modification is available, a Siemens service engineer will contact customers to schedule implementation of the modification for your system.
Siemens is providing the following instructions to minimise the risk of this issue:
· Ensure that the system is ready after the startup
· Ensure that the error 5000/243 is not displayed, neither as message box nor in the FLC status bar (lower left side of the left monitor)
· In general, avoid disconnecting and reconnecting the C-arm cable during or shortly before starting a procedure. This action has been closed-out on 31/08/2016. |
| Contact Information |
1800 310 300 - Siemens Technical Support Centre |