Events

Recall of syngo WorkFlow MLR with version VB30C_FP1, VB30E, VB35A, VB36A and "Portal Radiologist" license (radiology information system used to process data)

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-2013-RN-00303-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2013-04-05
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00303-1
  • 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
    If procedures requested have been deleted or changed (eg. because a procedure was replaced by a better fitting one in syngo workflow browser or portal radiologist), and the clinical information (risk factors, lab values, reason, diagnosis) was changed after the procedure was changed, then outdated clinical information (risk factors, lab values, reason, diagnosis) could be displayed in the user interface and saved (reason is that the outdated procedure with the outdated clinical information is used).
  • Action
    Siemens is providing users with work around instructions to prevent the problem occurring and is also developing a software correction to permanently correct the problem.

Device

syngo WorkFlow MLR with version VB30C_FP1, VB30E, VB35A, VB36A and "Portal Radiologist" license (...
  • Model / Serial
    syngo WorkFlow MLR with version VB30C_FP1, VB30E, VB35A, VB36A and "Portal Radiologist" license (radiology information system used to process data)ARTG Number: 184557
  • Manufacturer
    Siemens Ltd

Manufacturer

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