| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2013-RN-01317-1 |
| Product Name/Description |
SOMATOM CT System
SOMATOM Definition Flash running software version syngo CT2012B
SOMATOM Definition Edge running software version syngo CT2012B
SOMATOM Definition AS running software version syngo CT2012B
SOMATOM Definition running software version syngo CT2012B
SOMATOM Definition AS running software version syngo CT2013B
ARTG numbers: 164065 (SOMATOM system),160853 (syngo software) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
11/12/2013 |
| Responsible Entity |
|
| Reason/Issue |
Siemens has identified a software malfunction that may lead to a system display freeze during interventional procedures. If the function, "Auto save last displayed images as key images" is activated during an interventional procedure, the software configuration allows conflicting access to the CT system image database. In such situations, a system display freeze might occur. Normal interaction with the system is then no longer possible. No error message is issued and only a system restart resolves the problem. In case of a sudden system display freeze the interventionalist will potentially not immediately recognise the malfunction and continue the interventional procedure. There is a possibility of injury to a patient. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Siemens advising users to deactivate the "Auto save last displayed images as key images" function to prevent the issue from occurring. Images can continue to be saved manually. Siemens is providing a software update to permanently correct the issue in February 2014. This action has been closed-out on 29/01/2016. |
| Contact Information |
1800 310 300 - Siemens Technical Support Centre |