Events

Recall of syngo.plaza(Radiology picture archiving/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-2015-RN-00034-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2015-01-15
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00034-1
  • 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
    In the event of a system crash (e.G. bluescreen, power outage) the image may not be written from cache to the file system and may be lost in syngo.Plaza. when a further image is received, syngo.Plaza will allocate the same file name for the new image, and after some internal checks it will add the entry to the database for the new image. this gives rise to two references in the database to the same image which may lead to either:· the wrong image being displayed, which means for that series there is an image with a wrong examination parameter, and/or wrong examination (e.G. head/knee) and/or may be the wrong patient. this patient mix-up could lead to a wrong diagnosis, or· data loss in that an image is missing.To date this issue has not been reported by australian customers.
  • Action
    Siemens is providing a work around for customers whilst a permanent software fix is being developed. This action has been closed-out on 15/07/2016.

Device

syngo.plaza(Radiology picture archiving/communication system)
  • Model / Serial
    syngo.plaza(Radiology picture archiving/communication system)Lot numbers: 10863171 & 10863173ARTG number: 120332
  • Product Classification
    Radiology Devices
  • Manufacturer
    Siemens Ltd

Manufacturer

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