Events

Recall of Biograph, Symbia T and Symbia Intevo SPECT/CT systems

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-2018-RN-00654-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2018-06-05
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00654-1
  • 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 healthineers are aware of potentially incorrect tube-current calculations by the care dose4d algorithm when utilising only pa or ap topograms. depending on the geometrical shape of the skull, rare cases may occur in which the calculated dose distribution is not appropriate for scans that include the head, when based only on pa or ap topograms. the care dose4d software may select the maximum tube current for the uppermost part of the skull, which incidentally leads to unnecessary radiation exposure.
  • Action
    Siemens is advising that the manufacturer is developing appropriate solutions to address the problem with high priority. The described issue does not occur when using a lateral topogram. Accordingly, Siemens strongly recommend the utilization of topograms in the lateral position for all CT and PET/CT scans that include the entire head. Alternatively, if users choose to perform both a lateral topogram, in conjunction with a PA or AP topogram they must ensure that they perform the lateral topogram last as CARE Dose4D is based on the last topogram. If users do not utilize a lateral topogram for scans including the entire head, Siemens strongly recommend that users deactivate the CARE Dose4D feature.

Device

Biograph, Symbia T and Symbia Intevo SPECT/CT systems
  • Model / Serial
    Biograph, Symbia T and Symbia Intevo SPECT/CT systemsCatalogue Numbers: 8728581, 10097303, 10097289, 10097302, 10532746, 10532748, 10528958, 10529158, 10529160, 10529161, 10528955, 10507786, 10507786, 10534160, 10248669, 10248672, 10248673, 10248670, 10525581, 10764804, 10764802, 10764803, 11007962, 10764801, 10275007, 10275010, 10275008, 10275009 and 8717733.ARTG Numbers: 123883, 144218 and 271560.
  • Manufacturer
    Siemens Healthcare Pty Ltd

Manufacturer

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