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 Medical Systems.

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 106 10 18 000
  • Date de mise en oeuvre de l'événement
    2018-10-21
  • 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=13358
  • 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
    Kv/ma lockin not functioning as specified: the lock-in function is a fluoroscopy only function. when this function is enabled, the current radiation parameters, (kv and ma values), are retained to keep a consistent image impression. this is relevant for examinations of anatomies such as knee or shoulder, where the amount of dose at the detector is strongly influenced by the amount of direct radiation. due to a software bug, the ma values are not locked, but increase when the operator restarts pulsed fluoroscopy several times after activation of the lock-in function. as a result, the patient received an increased radiation dose stitching with skyplate aborts after first image: if there is an improper synchronization between the skyplate detector and the system, the preview offset image will have artifacts. if this happens, the system software identifies the preview image buffer as not usable during the first part image acquisition of the stitching run and as a result will abort the run. the stitching run has to be repeated.

Device

CombiDiagnost,
  • Modèle / numéro de série
    All CombiDiagnost systems with software version 1.0.0, 1.0.1 and 1.0.2
  • Description du dispositif
    CombiDiagnost
  • Manufacturer
    Philips Medical Systems

Manufacturer

Philips Medical Systems
  • Société-mère du fabricant (2017)
    Philips
  • Représentant du fabricant
    Al-Faisaliah Medical System, Riyadh, (01) 2119948
  • Source
    SFDA