| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2015-RN-00361-1 |
| Product Name/Description |
Siemens Ysio Max, Luminos dRF Max, Luminos Agile Max and Uroskop Omnia Max with software version VE10E
(fluoroscopic and standard diagnostic x-ray systems )
Catalogue Numbers: 10762470, 10762471
ARTG Numbers: 102184, 102182, 213886 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
23/04/2015 |
| Responsible Entity |
|
| Reason/Issue |
Images might be lost and corresponding acquisitions have to be repeated under the following circumstances:
· During an image recovery process on systems with portable detectors (MAX wi-D, MAX mini) the connection of the portable detector is sporadically not re-established.
· If either the “undo” button on the RAD subtask card or the “previous series” button on the Image subtask card are pressed during image readout.
· Sporadically, during an automatic or a manual RIS update. This may cause the deletion of the currently used study and all acquired images within this study. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Siemens is providing temporary instructions for users to follow to prevent the issues from occurring. A software update will be available in Q2 2015 which will permanently resolve the issue. This action has been closed-out on12/08/2016. |
| Contact Information |
1800 310 300 - Siemens Technical Support Centre |