Events

Recall of syngo Workflow SLR with versions VA31, VA32, VB10, or VB20A (TBC)(Radiology information 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-2015-RN-00443-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2015-05-28
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00443-1
  • 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 configured for the batching of orders, when an order transaction is received from a his interface, it is temporarily read into the system while waiting for the next transaction to come across the interface. if the next transaction is another procedure for the same patient, it would be "batched" with the first order until a transaction that is not an order for the "batched" patient is received or the maximum wait time of 10 seconds is exceeded. at this point, all the order(s) would be processed.If the system receives a shutdown request to restart the interface process while an order is within this 10 second "batching" window, the order may be lost with no indication to the user. this condition can happen when a user manually attempts to restart the interface process or when all of the application processes are restarted during the day-end processing sequence.
  • Action
    The issue can be avoided by not using the Order Batching feature. If the Order Batching feature is used. Users are recommended to configure the day-end processing to take place at the time with the anticipated lowest number of order transactions until the issue is solved in the software.For new upgrades or new installations, the issue will be solved in the syngo Workflow SLR software version VB20A_HF01 which is planned to be released in 02/2015. For existing VA31, VA32, VB10, and VB20A sites, the issue will be resolved following Safety Update Instruction SY038/15/S which is planned to be released in 02/2015. This action has been closed-out on 31/08/2016.

Device

syngo Workflow SLR with versions VA31, VA32, VB10, or VB20A (TBC)(Radiology information system)
  • Model / Serial
    syngo Workflow SLR with versions VA31, VA32, VB10, or VB20A (TBC)(Radiology information system) Catalogue number: 10558586ARTG number: 142663
  • Manufacturer
    Siemens Ltd

Manufacturer

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