| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2014-RN-00544-1 |
| Product Name/Description |
Wireless Footswitch used in conjunction with AXIOM Artis, Artis Zee and Artis Q Systems
Charging stations (catalogue no. 04787763) with serial numbers <10,000 are affected
ARTG Number: 145549 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
20/05/2014 |
| Responsible Entity |
|
| Reason/Issue |
If the wireless footswitch gets disconnected from the loading station due to an unintentional pull of the plug connection, the plug can become damaged.As a consequence, this could have the implication that the wireless footswitch can no longer be charged. Safe removal of the plug connection requires the interlocking mechanism to be loosened. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
The cabling that is currently being used will be replaced for all affected systems that are installed. The new solution has a coupling device that automatically unlocks upon draw. In addition, Siemens will provide an addendum for the operating manual that describes the appropriate handling required by the user. |
| Contact Information |
1800 310 300 - Siemens Technical Support |