Events

Alerte De Sécurité sur Nicolet® Cortical Stimulator Control Unit, Nicolet® C64 Stimulus Switching Unit (SSU) Amplifier and NicoletOne Software with Cortical Stimulator License

Selon Department of Health, ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Hong Kong qui a été fabriqué par CareFusion Corporation.

Qu'est-ce que c'est?

Les alertes fournissent des informations importantes et des recommandations concernant les dispositifs médicaux. Le fait qu'une alerte soit émise ne signifie pas nécessairement qu'un dispositif soit dangereux. Les alertes de sécurité, qui sont envoyées tant aux travailleurs du secteur médical qu'aux utilisateurs de ces dispositifs, peuvent inclure des rappels. Elles peuvent être rédigées par des fabricants mais aussi par des autorités en charge de la santé.

En savoir plus sur les données ici
  • Type d'événement
    Safety alert
  • Date
    2012-01-26
  • Pays de l'événement
    Hong Kong
  • Source de l'événement
    DH
  • URL de la source de l'événement
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20120126c.html
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
    Medical Device Safety Alert
  • Cause
    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...
  • Modèle / numéro de série
  • Classification du dispositif
    Neurological Devices
  • Description du dispositif
    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