Events

Recall of Biograph Horizon with VJ20A Software

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-00126-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2018-02-08
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00126-1
  • 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 has become aware of an issue with the pet quality control software that introduces an error into the pet normalization file. as a result there may be minimal visual and quantitative impacts to the pet images acquired and reconstructed with petsyngo vj20a software.
  • Action
    Siemens will be in contact with affected customers to arrange for a software update to be installed. In the event that users have any concerns about data that has been previously acquired and reconstructed prior to correction, users may refer to the Customer Letter for instructions for reconstructing data with a new normalization file.

Device

Biograph Horizon with VJ20A Software
  • Model / Serial
    Biograph Horizon with VJ20A SoftwareCatalogue Number: 10532746 and 10532748ARTG Number: 271560 (Siemens Healthcare Pty Ltd - Combination diagnostic imaging system, PET/CT)
  • Manufacturer
    Siemens Healthcare Pty Ltd

Manufacturer

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