Events

Recall of SOMATOM Definition AS when used with Patient table PHS1600 and software license for "Adaptive 4D Spiral"

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-2015-RN-01057-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2015-10-29
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-01057-1
  • 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 use of the combination phs1600 table with the perfusion scan mode 'adaptive 4d spiral' (typically used for critical diagnostic examinations) could occasionally initiate scan aborts. there is an increased risk of a scan abort when using the perfusion scan mode in combination with the phs1600 table, especially when applying contrast media. please note that the decreased performance stability is not affecting any other scan modes or the mechanical stability of the table in general.
  • Action
    Siemens is developing a solution for the use of the patient table PHS1600 in combination with the "Adaptive 40 Spiral" scan mode. Users are advised that they should be aware of the increased risk of a scan abort while using the perfusion scan mode in combination with the PHS1600 table. This action has been closed-out on 31/08/2016.

Device

SOMATOM Definition AS when used with Patient table PHS1600 and software license for "Adaptive 4D ...
  • Model / Serial
    SOMATOM Definition AS when used with Patient table PHS1600 and software license for "Adaptive 4D Spiral"ARTG Number: 164065
  • Manufacturer
    Siemens Healthcare Pty Ltd

Manufacturer

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