Events

Retiro De Equipo (Recall) de MX8000 IDT 16 Slice CT Scanner

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-2013-RN-00747-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2013-07-22
  • 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-2013-RN-00747-1
  • 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
    The ct system phantom supplied with the affected scanners has a special pin by which the customer can check the low contrast (lc) detectability for quality assurance. this pin consists of a nylon (aculon) body with six smaller lexan pins of 3mm, 4mm, 5mm, 6mm, 7mm and 8mm diameters, which have contrast difference of approximately 1% from aculon.The lc test is performed by visually inspecting the section and selecting the smallest detectable lexan pin for a predefined scan protocol as defined in the instructions for use (ifu) manual. this manufacturer-recommended procedure is subjective in nature and needs to be performed on several scans and by different people to be reliable.This pin visibility deteriorates over time because of slow water absorption. as the pin visibility deteriorates, the test becomes unreliable and inaccurate.
  • Acción
    The customer letter is providing a guideline to a more reliable check of the image noise on the water layer of the system phantom to assure that LC is within the specification. The letter is an addendum to the Instructions for Use. It replaces the Image Quality Low Contrast measurement instructions found in the Instructions for Use.

Device

MX8000 IDT 16 Slice CT Scanner

Manufacturer

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