Events

Retiro De Equipo (Recall) de Slit lamps HS010, SL 120, SL 130, SL 115 'Classic'

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 Carl Zeiss Ophthalmic Systems AG.

¿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
    21922
  • Fecha de inicio del evento
    2017-09-06
  • 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: Carl Zeiss (NZ) Ltd, 22 Fremlin Place, Avondale, Auckland 1026
  • Causa
    The manufacturer is aware that in certain devices there is an increased probability of 1) failure of the power supply on/off switch, and 2) surface corrosion of the mirror which changes the direction of the light projection. therefore the power supply on/off switch and the coating of the mirror has been modified to improve their reliability.
  • Acción
    Product to be exchanged

Device

Slit lamps HS010, SL 120, SL 130, SL 115 'Classic'

Manufacturer

Carl Zeiss Ophthalmic Systems AG