| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2013-RN-01037-1 |
| Product Name/Description |
Ysio, Luminos Agile, Luminos dRF and Uroskop Omnia Systems with software Versions VB10 and VC10 (diagnostic digital x-ray system)
Catalogue numbers – 10094200, 10094910, 10281163, 10281013, 10502200
Multiple serial numbers affected
ARTG Number: 102184 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
9/10/2013 |
| Responsible Entity |
|
| Reason/Issue |
During a RAD (Radiography) examination with automatic exposure control, a highly unlikely malfunction can result in radiation continuing longer than required. This malfunction occurs when the generator stops the tube power too late and therefore too much dose is applied during an acquisition. This may also result in an overexposed image that is not of diagnostic quality, so that the examination needs to be repeated. Statistically this malfunction only occurs once every 7000 images and only if images are taken in automatic exposure mode. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
It is not possible for the user to prevent this malfunction. The exposure time with the use of automatic exposure control is limited to 500ms, which is the maximum time that unwanted radiation will continue. The exposure can be interrupted by the user at anytime by releasing the exposure button. Siemens has implemented a field modification that will resolve the issues. The Australian roll out of this field modification is planned for completion in Q4 2013. This action has been closed-out on 11/02/2016. |
| Contact Information |
1800 310 300 - Siemens Technical Support Centre |