Siemens Somatom Emotion, Sensation, Perspective and Scope CT Systems with software versions VB42B, VC10A, VC20A, VC20B, VC28A, VC30A, VC30B and VC40A 의 리콜

Recall

RC-2018-RN-00183-1

Class II

2018-02-27

Australia

DHTGA

https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00183-1

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 dosedistribution 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.

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.