Events

Recall of unkown device

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 N/A.

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
    2004-04-08
  • Event Country
    France
  • Event Source
    ANSM
  • Event Source URL
    https://ansm.sante.fr/S-informer/Informations-de-securite-Retraits-de-lots-et-de-produits/alerte-sur-les-lits-medicaux-electriques-equipes-de-pedales-de-commande-de-hauteur-variable
  • 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
    Due to the persistence of reports of serious incidents related to an involuntary activation of a movement of the electric bed by acting on the variable height control pedal, the Afssaps broadcasts the alert attached (08/04 / 2004) (116 KB) at destination. health facility directors and local correspondents for materiovigilance for dissemination to technical, biomedical, purchasing and care services. the Directorate-General for Social Action for dissemination to the directors of institutions for the elderly and disabled. Each establishment must proceed or have the variable height pedals on the electric medical beds inactivated according to the specific protocols established by the manufacturers. The inactivation procedures that were provided to us by the manufacturers are available from the list below. The other competent European authorities have been informed of this measure. . List of manufacturers distributing in France beds equipped with variable height control pedals. updated: 13/05/0. To obtain the protocol (pdf format), click on the name of the manufacturer. . WORKSHOPS OF UPPER FOREZ (01/01/1970) (0 KB MATIFAS (07/04/2004) (2329 KB CORONA (14/04/2004) (615 KB MEDICATLANTIC (13/04/2004) (151 KB EDENA (13/04/2004) (1629 KB) MEYRA - no product distributed in English HILL-ROM (14/04/2004) (2972 KB MMO (08/04/2004) (1146 KB) EST ( 07/04/2004) (4554 KB SOTEC (08/04/2004) (118 KB MALVESTI TASSERIT (13/05/2004) (8 KB)

Device

unkown device
  • Model / Serial
  • Product Description
    medical_device
  • Manufacturer
    N/A

Manufacturer

N/A
  • Source
    LAANSM