Events

Retiro De Equipo (Recall) de NEURO TRAC MYO PLUS2

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

¿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
    133738
  • Clase de Riesgo del Evento
    III
  • Fecha de inicio del evento
    2011-07-12
  • 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
    An anomaly was found in the software in a limited number of myoplus 2 devices. in certain circumstances (both stimulation channels turned up the difference in intensity between the channels is more than 5 ma) this anomaly can cause the muscle stimulation output of channel 1 to stop increasing when the display on the lcd passes 45 ma. even though continued pressing of the channel 1 "ma+" control button increases the reading on the lcd display up to the maximum of 90 ma the actual output stays at 45 ma. however if and when the intensity of channel 2 is increased as you pass 47 ma channel 1 immediately corrects itself so that the output ma is the same as the lcd display for channel 1. the same problem exists in channel 2 if channel 2 is the first to be turned up past 45 ma and then channel 1 is increased above 47 ma. a potentially hazardous situation associated with the use of the device is a sudden surge of stimulation on one of the output channels which could be experienced by users as an unpleasant shock situation.

Device

NEURO TRAC MYO PLUS2
  • Modelo / Serial
    Model Catalog: MYO220 (Lot serial: 2011 MYO220 001)
  • Descripción del producto
    NEURO TRAC MYO PLUS2
  • Manufacturer
    REMINGTON MEDICAL EQUIPMENT LTD.

Manufacturer

REMINGTON MEDICAL EQUIPMENT LTD.