Events

Retiro De Equipo (Recall) de INSTATRAK 3500 PLUS SYSTEM

Según Health Canada (via FOI), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Canada que fue producido por GENERAL ELECTRIC CANADA (OPERATING AS GE 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
    151165
  • Clase de Riesgo del Evento
    III
  • Fecha de inicio del evento
    2011-03-30
  • 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
    The customer labelling for transmitter sensor cables and receiver sensor cables states that the cables can be sterilized with the sterrad sterilization system. at the initial release of these products the only sterrad method was the 100s model. sterrad has since introduced the 100nx and nx models. the transmitter sensor cable and receiver sensor cable have been validated for sterilization in the sterrad 100s sterilizer and ethylene oxide (eto) sterilizers only. these products have not been validated for use in any other sterrad sterilizer. ge oec medical systems inc. internal testing has shown the high concentration of hydrogen peroxide used in the sterrad 100nx sterilizer is not compatible with some of the materials used in the transmitter sensor cable which may result in the degradation of the material. this could lead to a sterilization issue. testing shows that the receivers are not affected by the change in sterilization.

Device

INSTATRAK 3500 PLUS SYSTEM
  • Modelo / Serial
    Model Catalog: 1007907-NAV (Lot serial: ALL); Model Catalog: 1007914-NAV (Lot serial: ALL); Model Catalog: 1001989 (Lot serial: ALL); Model Catalog: 1002008 (Lot serial: ALL); Model Catalog: 1001990 (Lot serial: ALL); Model Catalog: 1004069 (Lot serial: ALL)
  • Descripción del producto
    INSTATRAK 3500 PLUS - Sensor Cables
  • Manufacturer
    GENERAL ELECTRIC CANADA (OPERATING AS GE HEALTHCARE)

Manufacturer

GENERAL ELECTRIC CANADA (OPERATING AS GE HEALTHCARE)