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.

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 001 04 12 000
  • Date de mise en oeuvre de l'événement
    2012-04-03
  • 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=1632
  • 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
    Philips healthcare has received reports of three occurrences where the monitor ceiling suspension system fell to its lowest position. in one occasion it collided with the table top. no patient harm has been reported. the investigation initiated concluded that the cause of the failure was an assembly error of the actuator of the mcs.

Device

Radiographic/Fluoroscopic Systems
  • Modèle / numéro de série
    System: Allura Systems FD10 , FD20, FD10/10, FD20/10 and FD20/20 (*) shipped between November 15th 2011 and March 15th 2012 that include an Actuator with an assembly error (Actuator Short Assy: 989600-184-665 and Actuator Long Assy: 989600-184-654). A limited number of Allura Sytems (3 FD10 and 1 FD20/20) (**) in which the Actuator has been replaced by an Actuator with an assembly error. (*) Productcodes: 722010, 722011, 722012, 722013, 722014, 722015, 722019, 722020, 722022, 722023, 722024, 722025 (**) Product codes: 722001, 722003 and 722008
  • Description du dispositif
    Radiographic/Fluoroscopic Systems, Angiography/Interventional
  • Manufacturer
    Philips Healthcare

Manufacturer

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