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 121 07 18 000
  • Date de mise en oeuvre de l'événement
    2018-07-24
  • 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=12959
  • 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 received a complaint reporting that a monitor ceiling suspension (mcs) with a flexvision 56-inch large screen fell to the ground. the actuator assembly of the mcs became detached and the monitor carriage with the flexvision monitor dropped to the ground. the monitor ceiling suspension is designed to allow flexible positioning near the patient table when in use, and away from the patient table when not in use. (parked position).

Device

Allura Xper, integris systems.
  • Modèle / numéro de série
    All systems mentioned in the attached file that were delivered with an actuator for the FlexVision Monitor Ceiling Suspension in the period 2003 to May 201 1 are affected. Allura Xper FD10 C : 722001 Allura Xper FD10 F : 722002 - Please check attachment for all AFFECTED PRODUCTS -
  • Description du dispositif
    Monitor Ceiling Suspension (MCS)
  • Manufacturer
    Philips Healthcare

Manufacturer

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