| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2016-RN-00401-1 |
| Product Name/Description |
Somatom Force with software versions, VA50A and VA50A_SP2 with paediatric kernel Hp38 (Computed Tomography (CT) system)
Catalogue Number: 10742326
ARTG Number: 164065 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
5/04/2016 |
| Responsible Entity |
|
| Reason/Issue |
The manufacturer has advised that the use of the Neonate Head protocol with the paediatric kernel Hp38 could result in artefacts and possibly lead to misdiagnosis. Either not existing blood or liquid is mimicked in the images or actually existing blood or liquid is not depicted as expected. Investigations revealed a wrong parameterisation of the reconstruction algorithm applied for the paediatric head kernel as cause of the problem. This does not affect other kernels or reconstruction modes. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Siemens is advising users not to use the Neonate Head protocol with paediatric kernel Hp38 and is recommending using kernel Hr38 instead. The reconstruction of images is based on raw data, the data acquisition parameters are not affected and no additional dose is applied to the patient. A software upgrade will be performed as a permanent correction. This action has been closed-out on 03/02/2017. |
| Contact Information |
1800 310 300 - Siemens Technical Support Centre |