| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2016-RN-00950-1 |
| Product Name/Description |
SOMATOM Definition AS, Definition Edge and Definition Flash CT scanners with coupled contrast agent injectors in software version VA48A-SP2
(diagnostic computed tomography x-ray system)
ARTG Number: 274034 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
18/07/2016 |
| Responsible Entity |
|
| Reason/Issue |
Siemens have identified that when using the affected devices with software version VA48A-SP2, problems can occur with the contrast agent injectors, regardless of the brand of injector involved. Due to an internal communication error between the firmware and the software of the components involved, the planned CT scan is properly executed, however the injector is not started. This affects only the automatic mode, which is also called the "coupled mode", i.e. does not concern the manual control of the injector. As a result of this error, the contrast agent is not injected and the desired examination result is not achieved. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Siemens is advising users to stop using the automatic "coupled mode", and to only use control manually. Siemens will be implementing a firmware correction as a permanent fix. This action has been closed-out on 22/02/2017. |
| Contact Information |
1800 310 300 - Siemens Customer Care Centre |