| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2015-RN-00399-1 |
| Product Name/Description |
Cios Alpha mobile C-arm x-ray system
Catalogue number: 10308191
ARTG number: 102180 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
13/05/2015 |
| Responsible Entity |
|
| Reason/Issue |
Under certain circumstances the following user actions may cause the system to freeze.
·When images were transferred from the left monitor to the right monitor (function A to B) during image acquisition (i.e. radiation on) or shortly before starting image acquisition
·When acquisition of image was started while storing of scenes initiated by pressing the Store button was still in progress
·When scene replay was initiated either automatically or by pressing the “play” button (especially when pressing the “play” button more than once) while the storing of those scenes was still in progress
·When image acquisition was initiated again before automatic replay of the last scene started
·When finalized CD/DVDs were used to store additional data
·When radiation summary reports with more than 190 entries were being exported
·When system restart was initiated when the error message “System blocked. Turn system off/on” (error codes 215/80 and/or 208/80) was displayed. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Siemens has provided a workaround whilst a system modification is being developed which is expected for July 2015. This action has been closed-out on 11/08/2016. |
| Contact Information |
1800 310 300 - Siemens Technical Support Centre |