| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2013-RN-01083-1 |
| Product Name/Description |
Luminos dRF and Uroskop Omnia systems with Software Version VD10
Catalogue Numbers:10094200, 10094910
Siemens Reference Numbers: XP031/13/S
ARTG Number: 102184 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
25/10/2013 |
| Responsible Entity |
|
| Reason/Issue |
Siemens has identified the following potential malfunctions:
1. During a RAD (Radiography) examination with automatic exposure control, a highly unlikely malfunction can result in radiation continuing longer than required. This malfunction happens 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. (Note: this issue also affects software versions VC10 and VB10. Devices running this software are being corrected under recall RC-2013-RN-01037-1.)
2. When selecting a Tomo OGP, in some cases the Luminos dRF system shows a message "Wait for FLC" and this state does not change on its own.
3. Radiation is not activated and therefore an exposure is performed without radiation. |
| 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/Q1 2014. |
| Contact Information |
1800 310 300 - Siemens Technical Support |