Events

Recall Or Safety Alert for All the cardiovascular X-ray imaging systems Advantx, Innova 2000, Innova 2100IQ, Innova 3100, Innova 3100IQ, Innova 4100 and Innova 4100IQ equipped with superior video monitor in suspension

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 GE Medical Systems SCS.

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
    2013-10-01
  • 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 fall of the upper video monitor in suspension of certain cardiovascular X-ray imaging systems, manufactured by GE Medical Systems SCS, France.

Device

All the cardiovascular X-ray imaging systems Advantx, Innova 2000, Innova 2100IQ, Innova 3100, In...

Manufacturer

GE Medical Systems SCS