Events

Recall of syngo Workflow MLR

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-00097-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2018-02-07
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00097-1
  • 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
    While creating or modifying a report using microsoft word application in classic client, when content is pasted form an external source including the formatting 'section break' or by inserting it manually, data from the pre-defined sections of the template might not be saved to the syngo workflow mlr database. this incomplete report from the database issued for distribution to external systems e.G. his, pacs or fax. in the classic client report viewer the content is complete.To date, no harm has been reported as a result of this issue.
  • Action
    Siemens is preparing a correction to rectify this issue. In the interim, users are advised to always use the standard report creating options of syngo Workflow MLR Classic Client: 1. Use the online speech recognition to dictate the report with the supplied microphone. 2. Type content in the report editor. 3. Use auto text module to speed up the reporting process. 4. Only copy/paste from ASCII view of prior reports in syngo Workflow MLR Classic Client. In the case that users cannot avoid copy and pasting within the same document or from external applications, on all syngo Workflow MLR workstations the default paste option of the Microsoft Word application shall be set to 'KeepTextOnly'. Users may refer to the Customer Letter for further instructions regarding this. In the event that a report was created using copy and paste, users should always verify the content for completeness. Instructions for this are provided in the Customer Letter.

Device

syngo Workflow MLR
  • Model / Serial
    syngo Workflow MLRCatalogue Lot number: 10014099ARTG Number: 184557 - cancelled
  • Manufacturer
    Siemens Healthcare Pty Ltd

Manufacturer

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