Retiro De Equipo (Recall) de CHROMOVIEW FLAT PANEL ARM

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

¿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
    24776
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2010-01-21
  • País del evento
  • 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
    The problem involves a mechanical failure of the welted joint within the spring arm resulting in the rapid drop of a monitor to the panel to the mechanical stop.

Device

  • Modelo / Serial
    Model Catalog: TRAGARM (Lot serial: >THAN 10 PLEASE CONTACT MFG); Model Catalog: FP (Lot serial: >THAN 10 PLEASE CONTACT MFG); Model Catalog: 224 FP (Lot serial: >THAN 10 PLEASE CONTACT MFG); Model Catalog: 224 (Lot serial: >THAN 10 PLEASE CONTACT MFG); Model Catalog: C571/572 (Lot serial: >THAN 100 PLEASE CONTACT MFG); Model Catalog: C450/452 (Lot serial: >THAN 100 PLEASE CONTACT MFG); Model Catalog: C200 (Lot serial: >THAN 100 PLEASE CONTACT MFG); Model Catalog: C300 (Lot serial: >THAN 100 PLEASE CONTACT MFG); Model Catalog: C450 (Lot serial: >THAN 100 PLEASE CONTACT MFG); Model Catalog: C571 (Lot serial: >THAN 100 PLEASE CONTACT MFG); Model Catalog: C570 (Lot serial: >THAN 100 PLEASE CONTACT MFG); Model Catalog: C950 (Lot serial: >THAN 100 PLEASE CONTACT MFG); Model Catalog: LED 668 (Lot serial: more than 10 lot numbers); Model Catalog: LED 558 (Lot serial: more than 10 lot numbers); Model Catalog: LED 778 (Lot serial: more than 10 lot numbers); Model Catalog: E520 (Lot serial: more than 10 lot numbers);
  • Descripción del producto
    CHROMOVIEW FLAT PANEL ARM
  • Manufacturer

Manufacturer