Events

Safety Alert for Equipment for Lithotripsy

According to National Institute of Drugs and Food Surveillance (INVIMA), this safety alert involved a device in Colombia that was produced by Storz Medical Ag.

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
    I1603-88
  • Event Number
    2010EBC-0006174
  • Date
    2016-03-02
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=154
  • 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 informs that due to the addition of tolerances of the insert of the referenced table and of the cutting table, this can be removed from its position, leading to the occurrence of potentially adverse events on the patients.

Device

Equipment for Lithotripsy
  • Model / Serial
    SLX-F2, concerning the insert of the carbon fiber table as an optional part of the Urology Kit, serial || OR.079, OR.269, OR.110 and OR.299.
  • Product Description
    Used in urology for the treatment of kidney stones, urethral stones, bladder stones, IPP, CPPS.
  • Manufacturer
    Storz Medical Ag

Manufacturer

Storz Medical Ag