Events

Retiro De Equipo (Recall) de CombiDiagnost R90

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 Philips Medical Systems DMC GmbH.

¿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
    22314
  • Fecha de inicio del evento
    2017-11-24
  • 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
    The manufacturer has become aware that in some combidiagnost deliveries the tube adapter-plate green/yellow protective earthing wire was removed, during gcf tubes assembly, spacers with different thickness are used to position pre-loc ring in respect to focal spot in specified distance., there is a potential of an electrical shock if following factors occurs:, 1. an electrical failure leads to an electrical potential on the adapter plate, 2. the earth resistance based on mechanical connection is beyond limit, 3. person removes the tube cover. (not allowed for the customer), 4. person touches the live wired part during exposure/fluoroscopy.
  • Acción
    Product to be modified

Device

CombiDiagnost R90

Manufacturer

Philips Medical Systems DMC GmbH
  • Empresa matriz del fabricante (2017)
    Philips
  • Source
    NZMMDSA