Events

Safety Alert for Computer tomograph SOMATON

According to National Institute of Drugs and Food Surveillance (INVIMA), this safety alert involved a device in Colombia that was produced by Siemens A.G. || Siemens Shanghai Medical Equipment Ltd..

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Event ID
    I1401-23
  • Event Number
    2008EBC-0001864
  • Date
    2014-01-22
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=212
  • Notes / Alerts
    Colombian data is current through June 2019. All of the data comes from the National Institute of Drugs and Food Surveillance (INVIMA), 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 Colombia.
  • Extra notes in the data
  • Reason
    It was stated by the manufacturer that the software versions "syngo ct2012b, ct2013b" used in the aforementioned biomedical equipment can present conflicts in the "auto save image" mode, causing the image to be frozen, which can lead to an erroneous diagnosis. of the patient.

Device

Computer tomograph SOMATON
  • Model / Serial
    SOMATOM DEFINITION AS, SOMATOM DEFINITION FLASH, SOMATOM DEFINITION EDGE
  • Product Description
    Equipment for the production of cross-sectional images of the body by means of computer reconstruction of the X-RAY transmission.
  • Manufacturer
    Siemens A.G. || Siemens Shanghai Medical Equipment Ltd.

Manufacturer

Siemens A.G. || Siemens Shanghai Medical Equipment Ltd.
  • Manufacturer Parent Company (2017)
    Siemens Ag
  • Source
    NIDFSINVIMA