Events

Safety Alert for Mammography System

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. || Siemens Healthcare Gmbh.

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
    I1702-61
  • Event Number
    2008EBC-0002281
  • Date
    2017-02-20
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=101
  • 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 has identified that the referenced devices enabled with the biopsy functionality can block such a function, when the inversion tool is used simultaneously with the image scanogram (image of the explorer), leading to the occurrence of equipment blockages and possible adverse events on the patients.

Device

Mammography System
  • Model / Serial
  • Product Description
    This equipment is a universal mammography workstation for SCREENING and diagnosis in patients. Its intended use is to detect suspicious lesions in soft tissue for which special technical performance is required. It has the following clinical applications: mammography review, mammography diagnostic test, mammography magnification images, mammography with special compression plates and mammography biopsy-stereotactic.
  • Manufacturer
    Siemens A.G. || Siemens Shanghai Medical Equipment Ltd. || Siemens Healthcare Gmbh

Manufacturer

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