Events

Recall Or Safety Alert for XiO RTP System version 4.1.

According to Agencia Española de Medicamentos y Productos Sanitarios (Via FOI), this recall or safety alert involved a device in Spain that was produced by Impact Medical System.

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
    Recall / Safety Alert
  • Date
    2014-03-14
  • Event Country
    Spain
  • Event Source
    AEMPSVFOI
  • Notes / Alerts
    The data from Spain is current through June 2018. All of the data comes from Agencia Española de Medicamentos y Productos Sanitarios, 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 Spain.
  • Extra notes in the data
  • Action
    Possible incorrect dose calculation with Xio radiation treatment planning system version 4.1, manufactured by Impact Medical System, United States, when using the Elekta monitored wedges with dynamic shaped arches

Device

XiO RTP System version 4.1.

Manufacturer

Impact Medical System
  • Manufacturer Parent Company (2017)
    Elekta AB
  • Source
    AEMPSVFOI