Events

Recall of SYNGO.VIA

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by SIEMENS HEALTHCARE LIMITED.

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
    78053
  • Event Risk Class
    III
  • Event Initiated Date
    2013-09-19
  • Event Country
    Canada
  • Event Source
    HC
  • Notes / Alerts
    Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
  • Extra notes in the data
  • Reason
    Siemens is providing an update package for all systems running on syngo.Via software version va20. this resolves issues encountered with the following software applications: syngo.Via ct - in workflows that contain the mm reading workflow step especially ct neuro perfusion and ct dynamic angio data may not have been loaded to the mm reading workflow step if the data set was assigned to such a workflow scanner site. - in ct bone reading the edit rib function did not work properly: after scrolling multiple times in an mpr image the marker disappeared and after editing a centerline multiple times the edited rib was not correctly displayed in the unfolded rib view. - in ct coronary analysis heart segmentation in vrt images may have been of poor quality as some parts of the heart were missing. - in ct cardiac function the identification of the annular plane did not work in pediatric studies although the system confirmed a completion of preprocessing preprocessing was not completed. syngo.Via mr - in the neuro perfusion workflow the task "remaining images" was missing. therefore it could happen that some series were not available in the workflow. syngo.Via mi - in mm oncology editing a contour could lead to an erroneous segmentation.

Device

SYNGO.VIA
  • Model / Serial
    Model Catalog: 10496180 (Lot serial: LOT/SN: 100778 101414 101963)
  • Product Description
    SYNGO.VIA
  • Manufacturer
    SIEMENS HEALTHCARE LIMITED

Manufacturer

SIEMENS HEALTHCARE LIMITED
  • Manufacturer Address
    OAKVILLE
  • Manufacturer Parent Company (2017)
    Siemens Ag
  • Source
    HC