| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2014-RN-01318-1 |
| Product Name/Description |
Ysio Max, Luminos dRF Max and Luminos Agile Max (with software version VE10 including SmarthOrtho license)
ARTG Number: 102182, 102184 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
15/12/2014 |
| Responsible Entity |
|
| Reason/Issue |
Siemens has identified a potential malfunction which can occur when composed images are flipped on the integrated imaging system FLOUROSPOT Compact. When composed images are flipped (vertically or horizontally) the image information might become corrupted as a result of a software malfunction. The affected images and associated annotations such as labels (e.g. R/L) may show incorrectly.
The corrupt image information might lead to an incorrect diagnosis. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Siemens is providing a new software version that will permanently resolve the described malfunction. In the interim end users are advised to follow work around instructions to ensure the safe use of the systems Ysio Max, Luminos dRF Max and Luminos Agile Max systems. This action has been closed-out on 08/08/2016. |
| Contact Information |
1800 310 300 - Siemens Technical Support Centre |