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 Nucletron bv.

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 05 11 000
  • Date de mise en oeuvre de l'événement
    2011-05-29
  • 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=5&rid=450
  • 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: NCAR
    SFDA urges all hospitals that have devices subjected to recall, to contact the company.
  • Cause
    Investigation by the manufacturer showed that in the service mode the “source alignment procedure” could be started with the door physically open. the door interlock only triggers if the door is closed prior to alignment. the alignment can also be done with the doorswitch on linac . if set to linac , the door interlock to the hdr will always be seen by flexitron as being open. in the source alignment mode of the flexitron, the firmware does not look at the state of the door interlock but only to the state-change ( from closed to open). in this case the ir192 –source was thus not automatically retracted into the vault of the apparatus when opening the door of the irradiation bunker as the door switch only works in clinical mode.

Device

FLEXITRON HDR 40 CH(Diagnostic and therapeutic radiation device)
  • Modèle / numéro de série
    Software version: TDU (Treatment Delivery Unit): v 1.1.0 TCC ( Treatment Communication console ) : 1.2.1 Serial No: SYS00003
  • Description du dispositif
    Brachy therapy after loader, The Flexitron Remote After loader System enables an operator to remotely apply a radionuclide source (Ir192) into the body or to the surface of the body for radiation therapy. The Flexitron system is intended to be used in combination with applicators which make it suitable for intracavitary, interstitial,intralumenary, bronchial, endovascular, intra-operative and surface brachytherapy.
  • Manufacturer
    Nucletron bv

Manufacturer

Nucletron bv
  • Société-mère du fabricant (2017)
    Elekta AB
  • Source
    SFDA