Events

Recall of Somatom Force with software versions, VA50A and VA50A_SP2 with paediatric kernel Hp38 (Computed Tomography (CT) system)

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-2016-RN-00401-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2016-04-05
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00401-1
  • 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
    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.
  • Action
    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.

Device

Somatom Force with software versions, VA50A and VA50A_SP2 with paediatric kernel Hp38 (Computed T...
  • Model / Serial
    Somatom Force with software versions, VA50A and VA50A_SP2 with paediatric kernel Hp38 (Computed Tomography (CT) system)Catalogue Number: 10742326 ARTG Number: 164065
  • Product Classification
    Radiology Devices
  • Manufacturer
    Siemens Healthcare Pty Ltd

Manufacturer

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