Events

Recall of syngo Dynamics (Radiology picture archiving and communication system); Version 9.5

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-2012-RN-00754-3
  • Event Risk Class
    Class II
  • Event Initiated Date
    2012-07-27
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2012-RN-00754-3
  • 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
    If multiple uncompressed images/clips are sent to the syngo dynamics server around the same time, it is possible for an image from a patient to be placed in another patient's study. the dicom data may belong to the correct patient, but the pixel data may belong to another patient.
  • Action
    Siemens is providing work around instructions until a software fix can be implemented to permanently correct the issue.

Device

syngo Dynamics (Radiology picture archiving and communication system); Version 9.5
  • Model / Serial
    syngo Dynamics (Radiology picture archiving and communication system); Version 9.5ARTG Number: 196763
  • Manufacturer
    Siemens Ltd

Manufacturer

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