Events

Recall of SOMATOM DEFINITION - MAIN UNIT

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
    15559
  • Event Risk Class
    I
  • Event Initiated Date
    2012-12-21
  • 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
    There is a highly sporadic malfunction that concerns the 3d reconstruction functionality of the somatom systems. this problem may occur during the process of a 3d reconstruction job planning and editing within a specific funtionality while another functionality ("preview image") is activated. the problem presents itself as an error message window and the system needs to be rebooted.

Device

SOMATOM DEFINITION - MAIN UNIT
  • Model / Serial
    Model Catalog: 77 40 769 (Lot serial: VA34 OR VA40); Model Catalog: 77 40 769 (Lot serial: SOFTWARE VERSION VA20 VA27); Model Catalog: 77 40 769 (Lot serial: ANY SERIAL NUMBER RUNNING); Model Catalog: 10430603 (Lot serial: VA34 OR VA40); Model Catalog: 10430603 (Lot serial: SOFTWARE VERSION VA20 VA27); Model Catalog: 10430603 (Lot serial: ANY SERIAL NUMBER RUNNING); Model Catalog: 8098027 (Lot serial: ANY SERIAL NUMBER RUNNING); Model Catalog: 8098027 (Lot serial: SOFTWARE VERSION VA20 VA27); Model Catalog: 8098027 (Lot serial: VA34 OR VA40)
  • Product Description
    SOMATOM DEFINITION
  • Manufacturer
    SIEMENS HEALTHCARE LIMITED

Manufacturer

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