Events

Retiro De Equipo (Recall) de Ingenuity Core128 CT 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-2016-RN-00597-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2016-05-06
  • 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-2016-RN-00597-1
  • 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
    During production two different length fasteners were found to be made of stainless steel rather than the specified alloy steel. the nonconforming fasteners may have been used to manufacture ingenuity ct systems. the fasteners are used to secure sub-components of the adjustment cradle within the system gantry. analysis has concluded that the nonconforming fasteners continue to meet the tensile safety factor requirements for the application. however given the material characteristics of stainless steel, these fasteners may not be re-used (re-torqued). since the adjustment cradle requires periodic adjustment, it is expected that the nonconforming fasteners would require re-torqueing at some point during the system’s lifetime. repeated re-torqueing of the stainless steel fasteners could introduce stresses that approach the ultimate yield strength of the fasteners. there have been no reports of injuries.
  • Acción
    Philips is advising users that a field service technician will replace the affected screws on all affected systems.

Device

Ingenuity Core128 CT System

Manufacturer

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