Events

Recall of SYNGO DUAL ENERGY VIEWER

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

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
    106746
  • Event Risk Class
    III
  • Event Initiated Date
    2008-10-31
  • 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
    A problem when patient was scanned in a different position other than supine. saved images over the functionality "save sets ct" the orientation-labels from the saved images will not correspond to the image.

Device

SYNGO DUAL ENERGY VIEWER
  • Model / Serial
    Model Catalog: 10094833 (Lot serial: 1389); Model Catalog: 10094833 (Lot serial: 1249); Model Catalog: 10094833 (Lot serial: 1203); Model Catalog: 10094833 (Lot serial: 1177); Model Catalog: 10094833 (Lot serial: 1130); Model Catalog: 10094833 (Lot serial: 1027); Model Catalog: 10094833 (Lot serial: 1023); Model Catalog: 10094833 (Lot serial: 1390); Model Catalog: 10094833 (Lot serial: 1524); Model Catalog: 10094833 (Lot serial: 1661); Model Catalog: 10094833 (Lot serial: 1785); Model Catalog: 10094833 (Lot serial: 1877); Model Catalog: 10094833 (Lot serial: 1880); Model Catalog: 10094833 (Lot serial: 1925); Model Catalog: 10094833 (Lot serial: 2075); Model Catalog: 10094833 (Lot serial: 2311); Model Catalog: 10094833 (Lot serial: 1004); Model Catalog: 10094833 (Lot serial: 2191); Model Catalog: 10094833 (Lot serial: 2074)
  • Product Description
    SYNGO DUAL ENERGY VIEWER
  • Manufacturer
    SIEMENS CANADA LIMITED - HEALTHCARE

Manufacturer

SIEMENS CANADA LIMITED - HEALTHCARE
  • Manufacturer Address
    MISSISSAUGA
  • Manufacturer Parent Company (2017)
    Siemens Ag
  • Source
    HC