Events

translation missing: es.activerecord.attributes.event.titles.recall_field_safety_notice

Según Saudi Food & Drug Authority, este evento ( translation missing: es.activerecord.attributes.event.types.recall_field_safety_notice ) involucró a un dispositivo médico en Saudi Arabia que fue producido por Medtronic Navigation Inc.

¿Qué es esto?

Las notificaciones de seguridad de campo son comunicaciones sobre acciones que se pueden estar tomando en relación con un producto que se encuentra en el mercado, enviadas por los fabricantes de dispositivos médicos o sus representantes. Estas notificaciones son principalmente para trabajadores de la salud, pero también para usuarios. Pueden incluir alertas y retiro de equipos.

Más información acerca de la data acá
  • Tipo de evento
    Recall / Field Safety Notice
  • ID del evento
    mdprc 132 07 13 000
  • Fecha de inicio del evento
    2013-07-21
  • País del evento
    Saudi Arabia
  • Fuente del evento
    SFDA
  • URL de la fuente del evento
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=4&rid=3999
  • Notas / Alertas
    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.
  • Notas adicionales en la data
    Report Source: NCMDR
    SFDA urges all hospitals that have devices subjected to recall, to contact the company.
  • Causa
    Medtronic navigation, inc. has identified that the use of high resolution exams (greater than 256 x 256) under certain use conditions may cause the look‐ahead view labels to show user selected depths (displayed), but the corresponding images are shown at a depth twice the selected distance. under these conditions, visualization of the planned trajectory could show the image at the incorrect depth. further internal investigation of similar or related views discovered that the use of high resolution exams (greater than 256 x 256) under certain use conditions may cause a similar discrepancy between the exam image and the displayed measurement or overlay.

Device

Medtronic Navigation StealthStation S7 and i7 Systems and Planning Station containing FrameLink S...
  • Modelo / Serial
    The part numbers included in this corrective action are as follows: (1) Part Number 9734047 FrameLink S7 Applications Kit (2)Part Number 9734066 FrameLink S7 Planning Station Kit (3)Part Number 9733986 FrameLink Application Software
  • Descripción del producto
    Navigation system, Planning Station
  • Manufacturer
    Medtronic Navigation Inc

Manufacturer

Medtronic Navigation Inc
  • Empresa matriz del fabricante (2017)
    Medtronic plc
  • Comentario del fabricante
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Representante del fabricante
    Al Amin Medical Instruments Co. Ltd., Jeddah, (012) 6601149
  • Source
    SFDA