Events

Recall of PRAXIM navigation systems

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 PRAXIM.

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
    2006-12-27
  • 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-lots-de-marqueurs-utilises-dans-les-systemes-de-navigation-praxim
  • 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    The PRAXIM company has withdrawn from the market on December 26, 2006, the batches of the references specified in the appendix of the medical device called "markers used in the PRAXIM navigation systems" following a solder defect in a few bags that could lead to a risk of loss of sterility .. The company has directly notified the recipients of the incriminated lots with the message attached (27/12/2006) (118 KB) validated by the Afssaps .. This information is addressed to the directors of institutions health authorities and local correspondents for material vigilance for dissemination, where appropriate to the services concerned. The competent European authorities concerned shall be informed of this measure by the manufacturer.

Device

PRAXIM navigation systems
  • Model / Serial
  • Product Description
    medical_device
  • Manufacturer
    PRAXIM

Manufacturer

PRAXIM
  • Source
    LAANSM