Events

Recall of Symbia T and Symbia T2 Camera System (CT imaging system)

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Siemens 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-2014-RN-00340-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2014-03-17
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00340-1
  • 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
    In certain symbia t and t2 camera systems, circuit boards may come loose inside the ct enclosure due to fatigue of mounting rivets and damage the system components. this may result in an internal error causing the ct gantry to be inoperable.
  • Action
    A service engineer will replace the component fasteners on all affected units. If the gantry emits a loud pounding sound when operated end users are advised to contact a service representative immediately.

Device

Symbia T and Symbia T2 Camera System (CT imaging system)
  • Model / Serial
    Symbia T and Symbia T2 Camera System (CT imaging system)ARTG Number: 123883
  • Manufacturer
    Siemens Ltd

Manufacturer

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