| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2017-RN-00325-1 |
| Product Name/Description |
Wireless Foot Switch - Artis systems
Catalogue Numbers: 4787797, 4787805, 4787813
(Artis Systems supplied after 01 January 2005)
ARTG Number: 145549 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
8/03/2017 |
| Responsible Entity |
|
| Reason/Issue |
Siemens has identified an issue whereby the gap in the housing of the wireless foot switch can result in liquids penetrating the interior. Liquids may include disinfection and cleaning agents as well as bodily fluids. This can result in the failure of the foot switch. If the foot switch fails, it will no longer be possible to use it to release radiation. The hand switch provided can still be used to release exposures, but fluoroscopic examinations will not be possible. Consequently, a situation may arise whereby it is necessary to cancel or restart clinical treatment or to transfer treatment to a functioning system. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Siemens is currently working on a solution which is expected during the second quarter of 2017. Siemens generally recommend the use of sterile covers to protect the foot switch from all types of contamination. This is an effective way to prevent the foot switch from coming into contact with liquids. In the event of foot switch failure, users are further advised that the release of radiation for imaging purposes is still possible using the hand switch. Users are to note that standard emergency processes should be in place and ready for implementation until corrective actions are carried out.
This action has been closed out on 13/11/2018 |
| Contact Information |
1800 310 300 - Siemens Customer Care Centre |