Events

Retiro De Equipo (Recall) de Amo STAR Excimer Laser System

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 AMO Manufacturing USA, LLC.

¿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
    15562
  • Fecha de inicio del evento
    2013-10-30
  • 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: AMO Australia Pty Limited (NZ), c/- Exel New Zealand Limited, 3 - 5 Westfield Place, Mt Wellington, Auckland
  • Causa
    There is the potential to result in loss of illumination due to an unexpected failure of a component under high use conditions of the oblique and ring illumination lamps. this issue can be traced to overheating of a specific component found in a limited amount of star systems, which can result in a burning smell coming from the laser system. it does not affect laser pulse delivery. the treatment can continue without illumination of the surgical field at the surgeon's discretion. since all treatment steps (pulse by pulse) are stored in non-volatile memory, in the event of treatment interruption, when illumination is restored the surgeon can resume the treatment at the point where it was interrupted.
  • Acción
    Product to be modified

Device

Amo STAR Excimer Laser System

Manufacturer

AMO Manufacturing USA, LLC