| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2018-RN-00183-1 |
| Product Name/Description |
Siemens Somatom Emotion, Sensation, Perspective & Scope CT Systems with s/w versions VB42B, VC10A, VC20A, VC20B, VC28A, VC30A, VC30B & VC40A
ARTG Numbers: 142119 and 274034
(Siemens Healthcare - X-ray system, diagnostic, computed tomography, full-body) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
27/02/2018 |
| Responsible Entity |
|
| Reason/Issue |
Siemens Healthcare became aware of possible incorrect tube current calculations by the CARE Dose4D algorithm for scans that include the head, when based only on p.a. (posterior-anterior) or a.p. topograms. Depending on the geometrical shape of the skull bone, it may happen in rare cases that the calculated dose
distribution is not appropriate and could lead to unnecessary radiation exposure. The described issue will not occur when using a lateral topogram instead of a p.a. or an a.p. topogram. There have been no injuries reported as a result of this issue. |
| Recall Action |
Product Defect Correction |
| Recall Action Instructions |
Siemens is strongly recommending using lateral topograms for all head scans.
Considering that the p.a. or a.p. topogram is preferred in specific protocols such as in CarotidAngio scans and RT_ HeadNeckShoulder, it is strongly recommended to deactivate the CARE Dose4D function for this type of scan.
For software versions VB42B, VC10A, VC20A, VC20B, VC28A, VC30A, VC30B, VC40A, to prevent any possible deterministic radiation effects on the patient's skin or eye lenses, Siemens Healthcare implemented a dose alert according to the technical standard IEC 60601-2-44. A warning will be shown and has to be confirmed by the user if the accumulated CTDIvol for the ongoing examination exceeds the alert threshold in any z-position. The default setting for the threshold is adjusted to 1000 mGy.
This action has been closed out on 09/07/2019 |
| Contact Information |
1800 310 300 - Siemens Customer Care Centre |