Events

Retiro De Equipo (Recall) de Pentacam AXL, with software versions 1.21r01, 1.21r03, 1.21r11 and 1.21r13

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Designs for Vision Aust Pty 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-2017-RN-01424-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2017-11-20
  • 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-2017-RN-01424-1
  • 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 manufacturer, oculus optikgeräte, has identified recently that when a specific workflow sequence for performing the power calculation is utilised, the coloured display of the quality specification (qs) value changes from yellow to white, while the output values remained the same. the result is that the interpretation of the data, by solely considering the qs value, changes from “check the measurement results; repeating the measurement by having any doubts” (yellow flagged) to “the measurement is ok” (white flagged). although the device has a secondary warning (plausibility check) whereby the software flags any axial length difference greater than 0.3mm, indicating with a warning and displaying the suspicious difference of the axial length, the company has determined that in rare cases, this workflow sequence could result, in displaying an erroneous output. there have been no injuries as a result of this issue.
  • Acción
    Paragon Care is providing users with a software upgrade as a permanent correction.

Device

Pentacam AXL, with software versions 1.21r01, 1.21r03, 1.21r11 and 1.21r13
  • Modelo / Serial
    Pentacam AXL, with software versions 1.21r01, 1.21r03, 1.21r11 and 1.21r13Serial Numbers: 0031 7130, 2721 6111, 3821 7110ARTG Number: 175820 (Designs for Vision Aust Pty Ltd - Corneal topography system)
  • Manufacturer
    Designs for Vision Aust Pty Ltd

Manufacturer

Designs for Vision Aust Pty Ltd