Events

Recall of SOMATOM Force with software version VA50A

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-2017-RN-00487-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2017-04-19
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00487-1
  • 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
    An addendum is to be added to the instructions for use (ifu) of the somatom force system with software version va50a which is related to the use of the turbo flash mode with very short scan ranges. when selecting the turbo flash mode in combination with a spiral scan length of less than 27 mm the image reconstruction will possibly fail for this scan. as a workaround the addendum states for the turbo flash mode to always select a spiral scan length higher than 27 mm or to switch to another mode instead.
  • Action
    Siemens is advising users to always select a spiral scan length higher than 27mm or to switch to another mode when selecting the Turbo Flash Mode in combination with a spiral scan length of less than 27mm. (This information is contained in the addendum which will be posted to users). Users are requested to place this addendum in their User Manual and to disseminate the information to the relevant personnel at their organisation.

Device

SOMATOM Force with software version VA50A
  • Model / Serial
    SOMATOM Force with software version VA50ACatalogue Number: 10742326ARTG Number: 274034
  • Manufacturer
    Siemens Healthcare Pty Ltd

Manufacturer

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