Retiro De Equipo (Recall) de (2) Fortify-Assura (CD 1259-40, CD 1259-40 Q, CD 2259-40, CD 2259-40 Q, CD 1359-40, CD 1255-40, (3) Heart Minder ST (CD 1299-40, CD 1299-40 Q, CD 2299-40, CD 2299-40 Q, CD 2259-40, (5) Unify (CD3235-40, CD3235-40Q) (6) Unify Assura (CD 3361-40, CD 3361-40C) (4) Heart Minder + (CD 1391-40C, CD 1391-40 QC, CD 2391-40 C, CD 231-40 QC) (8) QUADORA ASSURA (CD 3367-40, CD 3367-40C, CD 3367-40Q, CD 3367-40 QC) (9) Excelis CRT (CD3367-40, CD3367-40QC) (7) Unified Quadra (CD3251-40, CD3251-40Q) (11) Exelis + CRT-D (CD3389-40C, CD3389-40Q, CD3389-40QC) (11) Excises + CRT-D (CD3389-40C, CD3389-40Q, CD3389-40QC) (10) Quadra + Excellis (CD3385-40C, CD3385-40Q, CD3385-40QC) (12) Exelis Quadra (CD 3281 - 40, CD 3281 - 40 Q)

Según Pharmaceuticals and Medical Devices Agency, Japan, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Japan que fue producido por St. Jude Medical Co., Ltd..

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
  • ID del evento
  • Fecha
  • País del evento
  • Fuente del evento
  • URL de la fuente del evento
  • Notas / Alertas
    Japanese data is current through August 2018. All of the data comes from the Japanese Pharmaceuticals and Medical Devices Agency, 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 Japan.
  • Notas adicionales en la data
    2016/10/25 "2. Correction of target lot, quantity and shipping time"


  • Modelo / Serial
  • Descripción del producto
    (1) - (12) Automatic implantable defibrillator, implantable biventricular pacing pulse generator with defibrillation function
  • Manufacturer


  • Empresa matriz del fabricante (2017)
  • 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