Events

Recall of SOMATOM Emotion 6 / 16 Slice Configuration systems manufactured before February 2008

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-2015-RN-00492-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2015-06-12
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00492-1
  • 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 three bolts used to fix the balance weight of the data measurement system (dms) may show signs of metal fatigue by producing an unusual noise whilst the gantry is in use and rotating. these bolts may potentially degrade over time and impact on stability of the balance weight. it should be noted that the rupture of a single bolt does not pose a hazard, however in the unlikely situation that all three bolts break, the dms balance weight is likely to drop into the gantry.This may cause serious patient injury and/or loss of scanned data and/or the machine rendered as out of service.No case reports have been received indicating patient injury.
  • Action
    Service engineers will be replacing all the bolts holding the DMS balance weight with a new bolt design. In the interim, to minimise a potential hazard Siemens recommends for users to carefully monitor the noise generated during gantry rotation. Since bolts will deteriorate over time, the balance weight will slowly change its position, potentially leading to a new sound pattern. Should users become aware of a change to the typical noise of the scanner we recommend that you immediately stop operation and contact a Siemens service engineer. This action has been closed-out on 05/09/2016.

Device

SOMATOM Emotion 6 / 16 Slice Configuration systems manufactured before February 2008
  • Model / Serial
    SOMATOM Emotion 6 / 16 Slice Configuration systems manufactured before February 2008Catalogue/Lot number – 10165888, 10165977, 10415118, 10415119 systems manufactured before February 2008ARTG number: 142119
  • Product Classification
    Radiology Devices
  • Manufacturer
    Siemens Ltd

Manufacturer

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