Events

Retiro De Equipo (Recall) de DISINFECTION SYSTEM - 208 VOLTAGE

Según Health Canada (via FOI), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Canada que fue producido por JOHNSON & JOHNSON MEDICAL PRODUCTS A DIV. OF JOHNSON & JOHNSON 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
    92384
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2013-04-01
  • 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
    Advanced sterilization products has determined that a limited number of evotech endoscope cleaner and reprocessor systems manufactured between 2011 and 2012 did not receive sufficient high potential dc voltage testing. this test is one of a series of tests required to verify that all electrical components within the system are performing as intended after systems are fully assembled.

Device

DISINFECTION SYSTEM - 208 VOLTAGE
  • Modelo / Serial
    Model Catalog: 50014-102 (Lot serial: 5041120176); Model Catalog: 50014-101 (Lot serial: 5041120176); Model Catalog: 50014-102 (Lot serial: 5041120168); Model Catalog: 50014-101 (Lot serial: 5041120168); Model Catalog: 50014-102 (Lot serial: 5041110160); Model Catalog: 50014-101 (Lot serial: 5041110160); Model Catalog: 50014-102 (Lot serial: 5041110159); Model Catalog: 50014-101 (Lot serial: 5041110159); Model Catalog: 50014-102 (Lot serial: 5041110126); Model Catalog: 50014-101 (Lot serial: 5041110126); Model Catalog: 50014-102 (Lot serial: 5041110125); Model Catalog: 50014-101 (Lot serial: 5041110125); Model Catalog: 50014-102 (Lot serial: 5041110124); Model Catalog: 50014-101 (Lot serial: 5041110124); Model Catalog: 50014-102 (Lot serial: 5041110122); Model Catalog: 50014-101 (Lot serial: 5041110122)
  • Descripción del producto
    EVOTECH ENDOSCOPE CLEANER & REPROCESSOR
  • Manufacturer
    JOHNSON & JOHNSON MEDICAL PRODUCTS A DIV. OF JOHNSON & JOHNSON INC.

Manufacturer

JOHNSON & JOHNSON MEDICAL PRODUCTS A DIV. OF JOHNSON & JOHNSON INC.
  • Dirección del fabricante
    MARKHAM
  • Empresa matriz del fabricante (2017)
    Johnson & Johnson
  • Source
    HC