Events

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

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Siemens Healthcare Pty Ltd.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    RC-2018-RN-00183-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2018-02-27
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00183-1
  • Notes / Alerts
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
  • Extra notes in the data
  • Reason
    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.
  • Action
    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.

Device

Siemens Somatom Emotion, Sensation, Perspective and Scope CT Systems with software versions VB42B...
  • Model / Serial
    Siemens Somatom Emotion, Sensation, Perspective and Scope CT Systems with software versions VB42B, VC10A, VC20A, VC20B, VC28A, VC30A, VC30B and VC40AARTG Numbers: 142119 and 274034(Siemens Healthcare - X-ray system, diagnostic, computed tomography, full-body)
  • Manufacturer
    Siemens Healthcare Pty Ltd

Manufacturer

Siemens Healthcare Pty Ltd
  • Manufacturer Parent Company (2017)
    Siemens AG
  • Source
    DHTGA