Events

Recall of SOMATOM DEFINITION FLASH SYS - MAIN

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
    62140
  • Event Risk Class
    III
  • Event Initiated Date
    2017-11-07
  • 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 healthcare became aware of possible incorrect tube current calculations by the care dose4d algorithm for head scans based on p.A. (posterior-anterior) or a.P. topograms. depending on the geometrical shape of the skull bone it may happen in rare cases that the calculated dose distribution is not appropriate. potentially the care dose4d software will select the maximum tube current for the uppermost part of the skull thus leading to unnecessary radiation exposure.

Device

SOMATOM DEFINITION FLASH SYS - MAIN
  • Model / Serial
    Model Catalog: 10430603 (Lot serial: N/A); Model Catalog: 77 40 769 (Lot serial: N/A); Model Catalog: 10742326 (Lot serial: N/A); Model Catalog: 10590000 (Lot serial: N/A); Model Catalog: 8098027 (Lot serial: N/A)
  • Product Description
    SOMATOM DEFINITION FLASH SYS -MAIN;SOMATOM DEFINITION-MAIN UNIT;SOMATOM FORCE;SOMATOM DEFINITION EDGE SYSTEM -CT SYSTEM;SOMATOM DEFINITION AS -MAIN UNIT
  • Manufacturer
    SIEMENS HEALTHCARE LIMITED

Manufacturer

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