Events

Recall of syngo Dynamics v9.5 with Sensis-syngo Dynamics Integration (Radiology picture archiving and communication 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-00425-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2014-04-17
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00425-1
  • 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
    Sensis reference numbers greater than 1,000,000 are wrongly modified during transfer to syngo dynamics. in this case during “in-progress” a study will get a sensisrefno for the wrong study in sensis. this will cause an incorrect link between syngo dynamics images and the sensis study data. when a patient study is opened in syngo dynamics a sensis report of another patient study is shown.The preconditions for this to occur are:- sensis-syngo dynamics integration- sensis study is opened from syngo dynamics while still "in progress"- sensis reference number is > 1000,000this could result in patient mismatch or a persistent unintended change to patient data could result. the patient mismatch is detectable when the study is opened for the first time if the toolbar is not configured to auto-hide.
  • Action
    Siemens is preparing a service patch modification that will resolve the potential malfunction. In the interim, end users are requested to discontinue opening "in progress" studies and to configure the “AXIOM Artis AE” title in syngo Dynamics to "Other" type of station. This action has been closed-out on 02/02/2016.

Device

syngo Dynamics v9.5 with Sensis-syngo Dynamics Integration (Radiology picture archiving and commu...
  • Model / Serial
    syngo Dynamics v9.5 with Sensis-syngo Dynamics Integration (Radiology picture archiving and communication system)ARTG number: 120332
  • Manufacturer
    Siemens Ltd

Manufacturer

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