Events

Field Safety Notices about PLATINIUM

According to Ministry of Health, State Institute for Drug Control, Coordination Center for Departmental Medical Information Systems, this field safety notices involved a device in Czechia that was produced by Sorin Group Italia S.r.l..

What is this?

Field safety notices are communications sent out by medical device manufacturers or their representatives in relation to actions that they may be taking in relation to their product that is on the market. These are mainly for health workers, but also for users. They can include recalls and alerts.

Learn more about the data here
  • Type of Event
    Field Safety Notice
  • Event ID
    1245
  • Date
    2017-08-17
  • Event Country
    Czechia
  • Event Source
    MHSIDCCCDMIS
  • Event Source URL
    https://eregpublicsecure.ksrzis.cz/Registr/RZPRO/FSN
  • Notes / Alerts
    Czech data is current through July 2018. All of the data comes from the Czech Public Registry of Medical Devices, 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 data from the U.S. and the Czech Republic.
  • Extra notes in the data

Device

PLATINIUM
  • Model / Serial
    Model Number: PLATINIUM VR 1210 PLATINIUM VR 1240 PLATINIUM DR 1510 PLATINIUM DR 1540 PLATINIUM CRT-D 1711 PLATINIUM CRT-D 1741 PLATINIUM 4LV CRT-D 1744 PLATINIUM SonR CRT-D 1811 PLATINIUM SonR CRT-D 1841 PLATINIUM 4LV SONR CRT-D 1844
  • Product Description
    Active implantable medical devices
  • Manufacturer
    Sorin Group Italia S.r.l.

Manufacturer

Sorin Group Italia S.r.l.