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 STERIS Corporation.

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 024 09 18 000
  • Date de mise en oeuvre de l'événement
    2018-09-11
  • 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=13132
  • 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
    Steris has identified that the welded connection between the main body of the ort 353c, ort 353d and ort 01g extension and the supporting bar may be incomplete; welding is only present on the top and underside instead of all around the connection point (affected components identified in red on the 3d images below). the incomplete weld may result in the component being weaker and subject to breakage when excessive downward force (exceeding 60kg) is applied. under normal use of the table and accessory, this amount of force is not expected to be applied; however, steris has received one report of component breakage during use related to the issue described above.

Device

ORT 353D, ORT 353C and ORT 01G Orthopaedic Extensions
  • Modèle / numéro de série
    ORT 353C, ORT 353D and ORT 01G Orthopaedic Extensions distributed from January 20, 2016 through April 26, 2018.
  • Description du dispositif
    Orthopaedic Extensions
  • Manufacturer
    STERIS Corporation

Manufacturer

STERIS Corporation
  • Société-mère du fabricant (2017)
    Steris Plc
  • Représentant du fabricant
    Al-Faisaliah Medical System
  • Source
    SFDA