Events

Safety Alert for Computerized tomograph DEFINITION AS

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
    I1511-521
  • Event Number
    2008EBC-0001864
  • Date
    2015-11-09
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=167
  • 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
    The manufacturer states that it has identified a malfunction when using the table and the referenced software which produces the occasional abortion of the scan, leading to potential delays in patient care and exposure.

Device

Computerized tomograph DEFINITION AS
  • Model / Serial
    SOMATON DEFINITION AS, concerning the PHS 1600 table in combination with the Adaptative 4D Spiral software
  • 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