Events

Notificaciones De Seguridad De Campo acerca de HeartMate II and HeartMate XVE LVAS 12 Volt Sealed Lead Acid Battery Clips

Según Swiss Agency for Therapeutic Products, este evento ( notificaciones de seguridad de campo ) involucró a un dispositivo médico en Switzerland que fue producido por Thoratec Corporation.

¿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
    Field Safety Notice
  • ID del evento
    Vk_20091023_01
  • Fecha de publicación del evento
    2009-10-26
  • País del evento
    Switzerland
  • Fuente del evento
    SATP
  • URL de la fuente del evento
    https://fsca.swissmedic.ch/mep/#?q=Vk_20091023_01
  • Notas / Alertas
    The data from Switzerland is current through March 2018. All of the data comes from Swiss Agency for Therapeutic Products, 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 Switzerland.
  • Notas adicionales en la data

Device

HeartMate II and HeartMate XVE LVAS 12 Volt Sealed Lead Acid Battery Clips
  • Modelo / Serial
    1237 | 458560206, 581080207
    581080507, 34331720107
    34404690108, 34532990109
    343317201407, 34331720207
    34331720507, 34404690208, 34404690308
    34404690408, 34432810108
    34450070108, 34477720108
    34570570109,34577730109
    34331720307 | manufactured and distributed
    between November 25, 2007 and October 5, 2009
  • Descripción del producto
    AIMD: Circulatory assist system
  • Manufacturer
    Thoratec Corporation

Manufacturer

Thoratec Corporation
  • Empresa matriz del fabricante (2017)
    Abbott Laboratories
  • Comentario del fabricante
    “We are in constant communication with regulatory agencies and competent authorities worldwide which allows us to implement global recalls or in-country communication quickly and effectively,” Abbott, which now owns St. Jude Medical told ICIJ in a statement. In addition to sending global notices to physicians worldwide, we also make sure that product advisories are available online and classification of product recalls and product advisories are determined by global regulatory bodies which can impact the timing in any given country. MD companies follow varying regulations in different countries. In come countries software is not regulated so a recall in one country related to software would not be classified as a recall or field action in another. In addition, review cycles within the regulatory process can be different in each country which can impact communication and recall timing.
  • Source
    SATP