Events

Recall of DM Batteries Defibrillation Electrodes Collapsible

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 Schiller Medical.

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
    2004-08-03
  • Event Country
    France
  • Event Source
    ANSM
  • Event Source URL
    https://ansm.sante.fr/S-informer/Informations-de-securite-Retraits-de-lots-et-de-produits/rappel-de-lots-du-dm-electrodes-de-defibrillation-collables-par-schiller-medical
  • 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
    Schiller Medical withdraws from the market batches bearing the expiry dates between August 2004 and November 2004 of the medical device called collapsible defibrillation electrodes - reference W1410241, manufactured by UnoMedical / Maersk / Niko, related to its FRED defibrillators, following several reports of malfunctions. These malfunctions seem due to poor aging of the electrodes due to the fragility of their packaging bag. A note. : the lots concerned by this recall are easily recognizable by the white color of the packaging bags; the customers concerned are directly notified by Schiller.

Device

DM Batteries Defibrillation Electrodes Collapsible
  • Model / Serial
  • Product Description
    medical_device
  • Manufacturer
    Schiller Medical

Manufacturer

Schiller Medical
  • Source
    LAANSM