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 SIEMENS.

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 088 07 12 000
  • Date de mise en oeuvre de l'événement
    2012-07-23
  • 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=2123
  • 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
    The issue is isolated images of pixel depth greater than 12 bit (99% of all stored images). problem exists prior to va20d as well" analysis showed that this behaviour is caused by a software bug. in some situations it can happen that a miscalculation is done for the grey scale values in the functions "region of interest", "pixel lens", "edge enhancement" and "histograms". the min/max value of pixel density in the functions "region of interest", "pixel lens", "edge enhancement" and "histograms" is not correct for images with a pixel depth greater than 12 bit. it has to be noted that the mentioned measurements shown in prior images are also not correct. all values which are calculated for images with a pixel depth less than or equal to 12 bits are correct.

Device

Picture archiving and communication system, radiology, Syngo. Plaza and Syngo Imaging XS
  • Modèle / numéro de série
    (1) System Label 10592 457 System version:VA20D (2) System Label104 96 279 System version:All versions VA70 and higher are affected
  • Description du dispositif
    picture archiving and communication system
  • Manufacturer
    SIEMENS

Manufacturer

SIEMENS
  • Société-mère du fabricant (2017)
    Siemens Ag
  • Représentant du fabricant
    Siemens Medical Solutions, Jeddah, (02) 6602933
  • Source
    SFDA