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 Trumpf Medical Systems, Inc..

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 049 04 16 000
  • Date de mise en oeuvre de l'événement
    2016-04-12
  • 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=9177
  • 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
    The universal arm support enables precise positioning of the patient’s arm during surgical procedures. during our continuous monitoring and analysis of trumpf medical products installed in the field customers have reported that the universal arm support may be unable to hold its set position and support the arm of the patient. the feedback describes the issue occurring while attempting to secure the position of the device. with this preventive field action trumpf medical proactively wants to ensure the safe intended use of the universal arm support. the product has not been involved with any reported injuries.

Device

Universal Arm Support
  • Modèle / numéro de série
    Product Name: Universal Arm Support 450 Model Number: 1697630 up to serial number: 102441510 Product Name: Universal Arm Support 450 T Model Number: 1697635 up to serial number: 102472407 Product Name: Universal Arm Support 600 Model Number: 1697639 up to serial number: 102406761 Product Name: Universal Arm Support 600 T Model Number: 1697651 up to serial number: 102412823 Product Name: Universal Arm Support 450 U Model Number: 1697660 up to serial number: 102426024 Product Name: Universal Arm Support 450 U T Model Number: 1697662 up to serial number: 102452250
  • Description du dispositif
    Arm Support
  • Manufacturer
    Trumpf Medical Systems, Inc.

Manufacturer

Trumpf Medical Systems, Inc.
  • Société-mère du fabricant (2017)
    Hill-Rom Holdings, Inc
  • Représentant du fabricant
    Al-Faisaliah Medical System, Riyadh (01) 2119999
  • Source
    SFDA