Events

Safety Alert for Nicolet® Cortical Stimulator Control Unit, Nicolet® C64 Stimulus Switching Unit (SSU) Amplifier and NicoletOne Software with Cortical Stimulator License

According to Department of Health, this safety alert involved a device in Hong Kong that was produced by CareFusion Corporation.

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
    Safety alert
  • Date
    2012-01-26
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20120126c.html
  • Notes / Alerts
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 Hong Kong.
  • Extra notes in the data
    Medical Device Safety Alert
  • Reason
    Field safety notice: recall of carefusion nicolet® cortical stimulator control unit, nicolet® c64 stimulus switching unit (ssu) amplifier and nicoletone software with cortical stimulator license medical device manufacturer, carefusion corporation, is conducting a voluntary recall of nicolet® cortical stimulator control unit, nicolet® c64 stimulus switching unit (ssu) amplifier and nicoletone software with cortical stimulator license. carefusion has identified potential risks associated with the cortical stimulator control unit, ssu amplifier and related software applications. affected units have the potential to develop a short circuit, and affected software licenses may display or capture the incorrect electrode annotation label on the cortical stimulator control unit screen and in the associated report. the united states food and drug administration (fda) has classified this action as a class i recall. according to the local supplier, the affected products are not distributed in hong kong. for details, please refer to the fda website: http://www.Fda.Gov/safety/recalls/ucm288493.Htm if you are in possession of the affected products, please contact your supplier for necessary actions.

Device

Nicolet® Cortical Stimulator Control Unit, Nicolet® C64 Stimulus Switching Unit (SSU) Amplifier a...
  • Model / Serial
  • Product Classification
    Neurological Devices
  • Product Description
    Medical Device Safety Alert: Recall of CareFusion Nicolet® Cortical Stimulator Control Unit, Nicolet® C64 Stimulus Switching Unit (SSU) Amplifier and NicoletOne Software with Cortical Stimulator License
  • Manufacturer
    CareFusion Corporation

Manufacturer

CareFusion Corporation