Events

Retiro De Equipo (Recall) de Radiometer TCM4 Transcutaneous Monitor

Según New Zealand Medicines and Medical Devices Safety Authority, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en New Zealand que fue producido por Radiometer Medical ApS.

¿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
    13859
  • Fecha de inicio del evento
    2012-12-04
  • País del evento
    New Zealand
  • Fuente del evento
    NZMMDSA
  • URL de la fuente del evento
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notas / Alertas
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
  • Notas adicionales en la data
    Recalling Organisation: Radiometer Pacific, Unit 3, 33 Spartan Road, Takanini 2105
  • Causa
    There is a potential risk of receiving an electrical shock under certain conditions as follows:, * the monitor is connected to the mains outlet and the mains switch is on, * the battery is fully charged (or no battery is present), * the operator disconnects the line cord (at either end) without first switching the mains switch on the back of the monitor to off, * the operator touches the two metal pins on the mains plug or on the monitor's line cord receptacle after disconnecting the line cord.
  • Acción
    Product to be modified

Device

Radiometer TCM4 Transcutaneous Monitor

Manufacturer

Radiometer Medical ApS