Events

Recall of syngo Workflow MLR using Portal Radiologist

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-2017-RN-00854-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2017-07-11
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00854-1
  • 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 has identified a potential issue with syngo workflow mlr where reports signed off in portal radiologist are sporadically not transferred to external systems. due to irregular synchronisation issues within an mlr application internal process, it can fail to return the appropriate data. the report will not be shared with external systems however the report content is intact within syngo workflow mlr.
  • Action
    For the 'Affected versions' of syngo Workflow MLR, a fix of this potential malfunction is in preparation by Siemens Healthcare GmbH via the upcoming syngo Workflow MLR software update version VB37B this issue will be resolved.

Device

syngo Workflow MLR using Portal Radiologist
  • Model / Serial
    syngo Workflow MLR using Portal RadiologistSoftware versions: VB30C, VB30E, VB30F, VB35A, VB35B, VB36A and VB37ACatalogue Number: 10014099ARTG Number: 274609
  • Manufacturer
    Siemens Healthcare Pty Ltd

Manufacturer

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