Events

Recall of Intracranial pressure kit

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 SOPHYSA.

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
    2007-10-09
  • 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-kit-de-pression-intracranienne-sophysa
  • 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
    On October 5, 2007, SOPHYSA withdrew from the market lots beginning with 7C or 6C of the following medical devices named. PRESSURE MONITORING PRESSURE MONITORING PRESSURE MONITORING KIT WITH BOLT REF. OSP-P. PRESSURE MONITORING KIT PRESSURE MONITORING PRESSURE INTRACRANIAL PARENCHYMATE TUNNELLIZABLE REF. OSP-P. PRESSIO® PRESSURE MONITORING KIT INTRACRANIAL VENTRICULAR TUNNELLIZABLE REF. PSO-VT,. manufactured by SOPHYSA, following a lack of electromagnetic insulation. The company SOPHYSA has directly notified the recipients of the incriminated lots with the message attached (09/10/2007) (219 KB) validated by Afssaps. This information is addressed to the directors and correspondents of materiovigilance for diffusion if necessary to the services concerned. The relevant European Competent Authorities are informed of this measure by the manufacturer.

Device

Intracranial pressure kit
  • Model / Serial
  • Product Description
    medical_device
  • Manufacturer
    SOPHYSA

Manufacturer

SOPHYSA
  • Source
    LAANSM