Events

Recall of Segufix support belts

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 Adhésia Laboratoire.

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
    2004-07-28
  • 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-ceintures-de-maintien-segufix-par-la-societe-adhesia-laboratoire
  • 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
    In agreement with AFSSAPS, Adhésia Laboratoire is recalling the Segufix support belts, references SG00, SG01 and SG 02, which are not equipped with lateral straps attached to the belt following several serious incidents of materiovigilance. The users of these seat belts were informed on 26 July 2004 of this reminder by the attached letter (26/07/2004) (194 KB). This recall follows a notification by the competent German authority ( Bfarm) .. This information concerns the directors of health establishments and local correspondents of materiovigilance for diffusion to the concerned services in particular the services of geriatrics and psychiatry.

Device

Segufix support belts

Manufacturer

Adhésia Laboratoire
  • Source
    LAANSM