Events

Retiro De Equipo (Recall) de Philips Gel-E Donut and Squishon 2

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 Childrens Medical Ventures.

¿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
    16979
  • Fecha de inicio del evento
    2014-07-22
  • 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: Philips New Zealand Commercial Limited, Level 3, 123 Carlton Gore Road, Newmarket, AUCKLAND 1023
  • Causa
    Mould has been found on some gel-e donut and squishon 2 gel-filled products. the mould manifests as small black markings on the outer surface of the gel-e donut and squishon pad, which are visible through the transparent outer packaging ., note: the transparent outer packaging prevents the migration of any mould in the environment and can be safely handled without risk of contamination.
  • Acción
    Product to be destroyed

Device

Philips Gel-E Donut and Squishon 2

Manufacturer

Childrens Medical Ventures
  • Empresa matriz del fabricante (2017)
    Philips
  • Source
    NZMMDSA