Events

Retiro De Equipo (Recall) de DISCOVERY MR750W 3.0T MAGNETIC RESONANCE IMAGING SYSTEM - MAIN UNIT

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
    25331
  • Clase de Riesgo del Evento
    III
  • Fecha de inicio del evento
    2015-08-31
  • 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 predicted head sar value from the modeling when using ge healthcare 3.0t mr scanners with the whole body rf transmit coil and receive-only surface coils for head and/or neck imaging suggests that actual sar delivered to the head could potentially exceed the 3.2 w/kg sar limit defined in iec60601-2-33. this issue does not affect mr scans performed outside the head and neck areas.

Device

DISCOVERY MR750W 3.0T MAGNETIC RESONANCE IMAGING SYSTEM - MAIN UNIT
  • Modelo / Serial
    Model Catalog: DISCOVERY MR750W 3.0T (Lot serial: 00000000UA0010); Model Catalog: DISCOVERY MR750W 3.0T (Lot serial: 663); Model Catalog: DISCOVERY MR750W 3.0T (Lot serial: 00000000UA0364); Model Catalog: DISCOVERY MR750W 3.0T (Lot serial: 00000000UA0042); Model Catalog: M3335JJ (Lot serial: 00000279069MR9); Model Catalog: M3335JJ (Lot serial: 00000HDMR10727); Model Catalog: M7000BD (Lot serial: 00000291154MR3); Model Catalog: M7000BD (Lot serial: 00000303327MR1); Model Catalog: M7000BD (Lot serial: 00000300711MR9); Model Catalog: M7000BD (Lot serial: 00000298951MR5); Model Catalog: M7000BD (Lot serial: 000000000R2726); Model Catalog: M7000BD (Lot serial: 00000296265MR2); Model Catalog: M7000BD (Lot serial: 00000299547MR0); Model Catalog: M7000BD (Lot serial: 00000291008MR1); Model Catalog: M7000BD (Lot serial: 00000296200MR9); Model Catalog: M7000BD (Lot serial: 00000300563MR4)
  • Descripción del producto
    DISCOVERY MR750W 3.0T MAGNETIC RESONANCE IMAGING
  • Manufacturer
    GENERAL ELECTRIC CANADA (OPERATING AS GE HEALTHCARE)

Manufacturer

GENERAL ELECTRIC CANADA (OPERATING AS GE HEALTHCARE)