Events

Recall of syngo Imaging XS and syngo.plaza (Radiology picture archiving and 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-2014-RN-01235-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2014-11-24
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-01235-1
  • 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
    Printouts may be printed in incorrect anatomical size when using syngo imaging xs/ syngo.Plaza filming application to print in anatomical size with a printer not appropriate for anatomical printing. this may happen due to an invalid combination of printer and the printer configuration file.
  • Action
    Only printers identified in the customer letter are validated to be used for anatomical printing. Siemens is recommending users to check their anatomical printouts by using the scale at the right-hand edge of the printout. The distance between two graduation lines corresponds to one centimetre in the anatomy. Please calculate any distances measured on the printout to correspond with this scale prior to printing. If customers have any printer which is not suitable for anatomical printing, they are advised to contact the Siemens Sales Representative. This action has been closed-out on 07/06/2016.

Device

syngo Imaging XS and syngo.plaza (Radiology picture archiving and communication system)
  • Model / Serial
    syngo Imaging XS and syngo.plaza (Radiology picture archiving and communication system)syngo Imaging XSModel numbers: 7502029 and 10496279, syngo.plaza Model numbers :10863173, 10592457 and 10863171ARTG number: 120332
  • Manufacturer
    Siemens Ltd

Manufacturer

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