Events

Retiro De Equipo (Recall) de Essenta DR Compact (Digital diagnostic X-Ray system)

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Philips Electronics Australia Ltd.

¿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
    RC-2012-RN-01094-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2012-10-29
  • País del evento
    Australia
  • Fuente del evento
    DHTGA
  • URL de la fuente del evento
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2012-RN-01094-1
  • Notas / Alertas
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • Notas adicionales en la data
  • Causa
    1. the weight of the u-arm on the essenta dr compacta is counterbalanced by two parallel suspension springs in the column. when a single spring breaks, there is a risk that the safety catch mechanism may not activate due to the counteracting force of the remaining spring. as a result, the u-arm moves down uncontrollably. this was observed during reliability tests on the steel rope within the vertical carriage where one of the springs broke and the safety catch did not hold. in a post market risk assessment it was detected, the item can occur in the field by 2.5 years of operation. these 2.5 years are calculated for a worst case usage of the system.2. during in house testing it was detected that the lifetime of the wire rope for the vertical movement is significantly lower than 10 years specified in the instructions for use. if the rope breaks, the safety catch will hold the u-arm under all circumstances.
  • Acción
    Philips Healthcare is replacing the vertical carriage, wire rope and Instructions for Use (IFU).

Device

Essenta DR Compact (Digital diagnostic X-Ray system)

Manufacturer

Philips Electronics Australia Ltd
  • Empresa matriz del fabricante (2017)
    Philips
  • Source
    DHTGA