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 040 08 15 002
  • Date de mise en oeuvre de l'événement
    2015-09-27
  • 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=8297
  • 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
    When a system parameter “maproute” is set to a value greater than 1, it is possible that not all images in an exam are processed and potentially one or more images may be missing from exams. there have been no injuries reported as a result of this issue. .................................. hpra update action : attention should be given to prior cases, acquired before this parameter was corrected, as they may be affected by the safety issue.

Device

Centricity PACS IW with Universal Viewer Version 5.0 and Centricity Universal Viewer Version 6.0 ...
  • Modèle / numéro de série
    Centricity PACS IW with Universal Viewer versions 5.0 through 5.0 SP7 and Centricity Universal Viewer version 6.0 ................... NCMDR update code: Centricity PACS-IW versions 3.5.0 through 3.7.3.9 SP2, 3.7.3 SPA10 and 4.0.1.
  • Description du dispositif
    Imaging device
  • Manufacturer
    GE Healthcare

Manufacturer

GE Healthcare