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 003 06 11 000
  • Date de mise en oeuvre de l'événement
    2011-06-04
  • 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=478
  • 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
    Due to an issue in the system time adjustment feature, the system time can drift. if unchecked, or not connected to a network time server, system time can drift, impacting standardized uptake value (suv) measurements. a fifteen minute difference between system time and the dose calibrator clock impacts suvs by 10%. discovery st systems without dimension consoles are not affected. no injury has been reported related to this issue.

Device

Positron Emission Tomography System
  • Modèle / numéro de série
    Discovery VCT, Discovery RX VCT, Discovery STE, Discovery RX and Discovery ST systems with Dimension console. Discovery ST systems without Dimension consoles are not affected.
  • Description du dispositif
    Nuclear Medicine System, Positron Emission Tomography andX-ray System, Diagnostic, Computed Tomography, Full-body
  • Manufacturer
    GE Healthcare

Manufacturer

GE Healthcare