Events

translation missing: fr.activerecord.attributes.event.titles.recall_field_safety_notice

Selon Saudi Food & Drug Authority, ce/cet/cette translation missing: fr.activerecord.attributes.event.types.recall_field_safety_notice concerne un dispositif en/au/aux/à Saudi Arabia qui a été fabriqué par GE Healthcare.

Qu'est-ce que c'est?

Les avis de sécurité sont des communications que les fabricants de dispositifs médicaux ou leurs représentants font parvenir en particulier aux travailleurs du secteur médical, mais aussi aux utilisateurs de ces dispositifs. Les avis de sécurité concernent les actions entreprises quant aux dispositifs présents sur le marché et peuvent inclure des rappels et des alertes.

En savoir plus sur les données ici
  • Type d'événement
    Recall / Field Safety Notice
  • ID de l'événement
    mdprc 033 08 12 000
  • Date de mise en oeuvre de l'événement
    2012-08-14
  • Pays de l'événement
    Saudi Arabia
  • Source de l'événement
    SFDA
  • URL de la source de l'événement
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=4&rid=2190
  • Notes / Alertes
    Saudi data is current through January 2019. All of the data comes from the Saudi Food & Drug Authority, 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 Saudi Arabia.
  • Notes supplémentaires dans les données
    Report Source: NCMDR
    SFDA urges all hospitals that have devices subjected to recall, to contact the company.
  • Cause
    While performing a fluoroscopic acquisition with the innova 2121iq or innova 3131iq systems, there is a potential for loss of usable imaging mode which requires the system to restart in order to recover. it may happen in a very specific scenario when one operator is requesting a lih (last image hold) functionality and another operator starts a short fluoroscopy exposure (stopping fluoroscopy exposure within 2 seconds) without waiting for the display of the lih (last image hold) in review monitor. the user would need to restart the system in order to regain acquisition capability. there can be an increased risk of complications during the procedure as a result of imaging functionality loss.

Device

Cardiovascular X-ray imaging systems, Innova 2121IQ, Innova 3131IQ
  • Modèle / numéro de série
    Innova 2121IQ, Innova 3131IQ
  • Description du dispositif
    Cardiovascular X-ray imaging systems
  • Manufacturer
    GE Healthcare

Manufacturer

GE Healthcare