Events

Retiro De Equipo (Recall) de MAMMOTOME REVOLVE DUAL VACUUM ASSISTED BIOPSY SYSTEM - STEREOTACTIC PROBE

Según Health Canada (via FOI), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Canada que fue producido por DEVICOR MEDICAL PRODUCTS INC..

¿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
    31532
  • Clase de Riesgo del Evento
    III
  • Fecha de inicio del evento
    2016-05-26
  • 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
    It has come to the attention of devicor medical products inc. that a mst1009 probe for the mammotome revolve biopsy device in a stereotactic application may have been mislabeled. it is a 10 gauge device with a 9 cm needle. in lot number f11537107d1 a mst1009 was in a mst0815 package for a single unit. this single unit was identified by a customer and returned.

Device

MAMMOTOME REVOLVE DUAL VACUUM ASSISTED BIOPSY SYSTEM - STEREOTACTIC PROBE
  • Modelo / Serial
    Model Catalog: MST0815 (Lot serial: F11537109D1); Model Catalog: MST1009 (Lot serial: F11537109D1); Model Catalog: MST1009 (Lot serial: F11537107D1); Model Catalog: MST1009 (Lot serial: F11536423D1); Model Catalog: MST0815 (Lot serial: F11537107D1); Model Catalog: MST0815 (Lot serial: F11536423D1)
  • Descripción del producto
    MAMMOTOME REVOLVE DUAL VACUUM ASSISTED BIOPSY SYSTEM
  • Manufacturer
    DEVICOR MEDICAL PRODUCTS INC.

Manufacturer

DEVICOR MEDICAL PRODUCTS INC.
  • Dirección del fabricante
    CINCINNATI
  • Empresa matriz del fabricante (2017)
    Danaher Corporation
  • Source
    HC