Events

Recall of HIRES 90K

According to L’Agence nationale de sécurité du médicament et des produits de santé (ANSM), this recall involved a device in France that was produced by Advanced Bionics.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Date
    2006-03-16
  • Event Country
    France
  • Event Source
    ANSM
  • Event Source URL
    https://ansm.sante.fr/S-informer/Informations-de-securite-Retraits-de-lots-et-de-produits/retrait-de-stimulateurs-cochleaires-implantables-hires-90k-de-la-societe-advanced-bionics
  • Notes / Alerts
    French data is current through early September 2018. All of the data comes from L’Agence nationale de sécurité du médicament et des produits de santé (ANSM), 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 France.
  • Extra notes in the data
  • Action
    The Afssaps was informed on 10/03/2006 of a withdrawal of implantable cochlear stimulators HIRES 90K made by Advanced Bionics the 07/03/2006 after the identification of stimulators with a humidity rate higher than the tolerances and being able to cause malfunctions of these devices. This file is being evaluated by Afssaps. Additional information may be disseminated later. The implanting centers concerned by this withdrawal, in France, have received the attached letter (16/03/2006) (26 KB). The other relevant European Competent Authorities have been informed of this measure by the European representative.

Device

HIRES 90K
  • Model / Serial
  • Product Description
    medical_device
  • Manufacturer
    Advanced Bionics

Manufacturer

Advanced Bionics
  • Source
    LAANSM