Events

Field Safety Notices about NicoletOne Software v5.60.2 through v5.71. with Cortical Stimulator License, Nicolet Cortical Stimulator Control Unit and the Nicolet C64 SSU Amplifier

According to Bundesinstitut für Arzneimittel und Medizinprodukte, this field safety notices involved a device in Germany that was produced by Carefusion Corporation.

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
    04746/11
  • Date
    2011-10-26
  • Event Country
    Germany
  • Event Source
    BAM
  • Event Source URL
    https://www.bfarm.de/SharedDocs/Kundeninfos/EN/10/2011/04746-11_kundeninfo_en.html
  • Notes / Alerts
    German data is current through October 2018. All of the data comes from Bundesinstitut für Arzneimittel und Medizinprodukte, 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 Germany.
  • Extra notes in the data

Device

NicoletOne Software v5.60.2 through v5.71. with Cortical Stimulator License, Nicolet Cortical Sti...
  • Model / Serial
  • Product Description
    Medical electronics / Electromedical devices
  • Manufacturer
    Carefusion Corporation

Manufacturer

Carefusion Corporation