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 Philips Healthcare Gamma Cameras.

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 086 08 17 000
  • Date de mise en oeuvre de l'événement
    2017-08-24
  • 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=11452
  • 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
    In order to save archiving space, the allura xper r9 systems and azurion r1.1 systems include the option of downscaling the image when exporting images to the external dicom destination (e.G., pacs). when using the downscale option, the measurements performed with the allura r9 system or azurion r1.1 system using the qa basic measurement tool will not be correctly exported to the external dicom destination. the difference between the original measurement and the exported measurement can vary. the distance value after export is factor 1 to 4 smaller than the original value. the difference will depend on the acquired image (e.G., x-ray protocol, field of view) and the used archive settings (i.E., downscale settings).

Device

Allura Xper R9 and Azurion R1.1
  • Modèle / numéro de série
    Allura Xper R9 and Azurion R1.1 systems with the QA Basic Measurement tool. Product names: Allura Xper R9 7M12, Allura Xper R9 7M20, Azurion 7M12; Azurion 7M20; Azurion 3M12; Azurion 3M15
  • Description du dispositif
    imaging systems
  • Manufacturer
    Philips Healthcare Gamma Cameras

Manufacturer

Philips Healthcare Gamma Cameras
  • Société-mère du fabricant (2017)
    Philips
  • Représentant du fabricant
    Philips Healthcare Saudi Arabia Ltd.
  • Source
    SFDA