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 087 07 13 000
  • Date de mise en oeuvre de l'événement
    2013-07-14
  • 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=3948
  • 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
    May exhibit various out-of-context problems. safety issue : ( description, affected products details); safety issue #1 : ( in centricity ris-ic, and a ris-driven integration, the “close” button closes the exam in ris-ic, but does not close the exam in centricity pacs ra1000 workstation, centricity pacs versions 3.2.2.3 and forward are affected ); safety issue #2 : ( interrupted workflow could break the synchronization between nuance powerscribe 360 and centricity pacs ra1000 workstation, centricity pacs versions 3.2 and forward are affected ); safety issue #3 : ( interrupted workflow could break the synchronization between agfa talk and centricity pacs ra1000 workstation, centricity pacs versions 3.1.1.2 and forward are affected ); safety issue #4 : ( centricity pacs ra1000 workstation distance measurements may not be calculated accurately when a modality sends a study to pacs which only contains values in the imager pixel spacing (0018, 1164), and magnification factor (0018, 1114) dicom tags but does not include a value in the pixel spacing (0020,0030) dicom tag, centricity pacs versions 2.X and forward).

Device

Centricity PACS RA1000 Workstations
  • Modèle / numéro de série
    Centricity PACS versions ( 2.1.5.6; 2.1.5.8; 2.1.5.9; 2.1.5.10; 2.1.5.11; 2.1.5.13; 3.1.1.2; 3.2; 3.2.0.1; 3.2.0.2; 3.2.1; 3.2.2; 3.2.2.1; 3.2.2.2; 3.2.2.3; 3.2.6; 3.2 SP7; 4.0; 4.0.1 )
  • Description du dispositif
    Workstations, Picture Archiving and Communication System
  • Manufacturer
    GE Healthcare

Manufacturer

GE Healthcare