Events

Retiro De Equipo (Recall) de ACUSON S2000 DIAGNOSTIC ULTRASOUND SYSTEM - MAIN UNIT

Según Health Canada (via FOI), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Canada que fue producido por SIEMENS CANADA LIMITED - HEALTHCARE.

¿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
    Recall
  • ID del evento
    68316
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2009-09-11
  • País del evento
    Canada
  • Fuente del evento
    HC
  • Notas / Alertas
    Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
  • Notas adicionales en la data
  • Causa
    There is an intermittent series of events in which a print or store event failure may cause the following to occur: a)the last image of a patient study can be stored with the next new patient study performed. b)if the first patient's last image had measurement results will appear on the next patient's image. c) when a distance ratio or area ratio measurement is performed with l testis mass 2 measurement label it appears in the report as r testis mass 2 in english only and d) more than 4 measurements of the same label are performed will not apear on-screen or printed report.

Device

ACUSON S2000 DIAGNOSTIC ULTRASOUND SYSTEM - MAIN UNIT
  • Modelo / Serial
    Model Catalog: 10041461 (Lot serial: 200252); Model Catalog: 10041461 (Lot serial: 200995); Model Catalog: 10041461 (Lot serial: 200979); Model Catalog: 10041461 (Lot serial: 200926); Model Catalog: 10041461 (Lot serial: 200334); Model Catalog: 10041461 (Lot serial: 200288)
  • Descripción del producto
    ACUSON S2000
  • Manufacturer
    SIEMENS CANADA LIMITED - HEALTHCARE

Manufacturer

SIEMENS CANADA LIMITED - HEALTHCARE
  • Dirección del fabricante
    MISSISSAUGA
  • Empresa matriz del fabricante (2017)
    Siemens Ag
  • Source
    HC