Events

Recall Or Safety Alert for Serial numbers H48F824, H48F825, H48F826 H48F827, H48F828 and H48F829 of the "EclipseTM treatment planning system", model H48, software version 11.0 with PBC software version 11.0.21 and 11.0.30, manufactured by Varian Medical Systems, Inc. .

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 Varian Medical Systems, Inc.

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
    2013-02-27
  • 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
    The calculation of the dose dynamics plans that include different energy fields with the "EclipseTM treatment planning system", software version 11.0, is incorrect when the filiform beam convolution algorithm is used

Device

Serial numbers H48F824, H48F825, H48F826 H48F827, H48F828 and H48F829 of the "EclipseTM treatment...

Manufacturer

Varian Medical Systems, Inc