Events

Recall of SOMATOM go.Up and SOMATOM go. Now

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-01261-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2017-10-03
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-01261-1
  • 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 have identified that the bolts on the patient table have been tightened with an inadequate torque, which may lead to a loose nut on the bolt. under unfavourable conditions several bolts may gradually loosen at the same time having an effect on the stability of the table.
  • Action
    Siemens is advising users that if there is any unusual noise or vibration to cease use of the CT system and contact Siemens immediately. Siemens will be correcting all affected units.

Device

SOMATOM go.Up and SOMATOM go. Now
  • Model / Serial
    SOMATOM go.Up and SOMATOM go. Now Catalogue Numbers: 11061628 and 11061618ARTG Number: 142119
  • Manufacturer
    Siemens Healthcare Pty Ltd

Manufacturer

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