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 GE 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 095 12 15 000
  • Date de mise en oeuvre de l'événement
    2015-12-23
  • 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=8667
  • 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
    Ge healthcare has recently become aware of an issue related to the operation of the safety latch within the column that supports the horizontal arm. this safety latch mechanism serves as a backup in the unlikely event the primary safety cable breaks. a fall of the arm assembly could result in bodily harm to a person. there have been no incidents or injuries reported as a result of this internally found issue.

Device

Optima XR200amx, Optima XR220amx and Brivo XR285amx X-ray imaging systems
  • Modèle / numéro de série
    All Optima XR200amx, Optima XR220amx and Brivo XR285amx X-ray imaging systems.
  • Description du dispositif
    X-Ray Imaging systems.
  • Manufacturer
    GE Healthcare

Manufacturer

GE Healthcare