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 159 04 18 000
  • Date de mise en oeuvre de l'événement
    2018-04-30
  • 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=12550
  • 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
    When the gantry front cover is removed to allow servicing of components inside the gantry, cover dollies are used to manipulate the cover. during the removal or reattachment of the front cover, a bracket can contact an internal power supply cable and damage that cable’s insulation. this can expose the conductor of a 120vac power supply cable and electrify the cover dolly, thereby introducing the risk of an electrical shock hazard to the service personnel.

Device

Revolution EVO & Optima CT660, CT670, CT680, CT540 Internal Electrical Cable
  • Modèle / numéro de série
    The following CT systems are affected: Revolution EVO (Models 5454001-61 GTIN 00840682109796, 5454001-160 GTIN 00840682109796, 5454001-60 GTIN 00840682109796, 5454001-260 GTIN 00840682109796) Optima CT660 (Models 5454001, 5454001-41, -100, -220, -200, -40, -22, -140, -240, -122, -222) Optima CT670/680 (Model 5454001-230, 5454001-330) Optima CT540 (Models 5432539 GTIN 00840682138963, 5432539-2 GTIN 00840682138963, 5432539-3 GTIN 00840682102551, 5432539-5 GTIN 00840682102551, 6447929)
  • Description du dispositif
    X-ray system, diagnostic, computed tomography
  • Manufacturer
    GE Healthcare

Manufacturer

GE Healthcare