Events

Recall Or Safety Alert for Electrosurgical generator ESG-100, models WB991036 and WB991046, software version 2.11, serial numbers from 11052P230001 to 11265P230003 and from 25477W23-101 to 27085W23-101

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 Celon AG Medical Instruments.

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
    2012-02-02
  • 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
    Possibility that the capacitors C17 and C18 of certain ESG-100 electrosurgical generators manufactured by Celon AG Medical Instruments, Germany, can be falsified components and can show failures with greater probability.

Device

Electrosurgical generator ESG-100, models WB991036 and WB991046, software version 2.11, serial nu...

Manufacturer

Celon AG Medical Instruments
  • Source
    AEMPSVFOI