Events

Retiro De Equipo (Recall) de Spot Vision Screener 100 with software version up to and including 3.0.01.07

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

¿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-2018-RN-00138-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2018-03-28
  • 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-2018-RN-00138-1
  • 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
    If the device is not used or charged every five months, the coin cell battery that maintains the system clock may become depleted. once the coin cell battery has depleted, the system clock will reset to a date in the past (date of the last installed software release for example). this may cause the patient age to be calculated incorrectly. please note, the patient age is used by the spot vision screener 100 to determine referral criteria for certain screening conditions–specifically anisometropia, myopia, astigmatism and hyperopia. an incorrect patient age could result in an incorrect (either under or over) referral recommendation.
  • Acción
    Welch Allyn is recommending users review new software releases and determine if the device should be updated. Software updates can be downloaded at www.welchallyn.com.au. In the interim, users are advised to refer to the additional instructions to re set the system clock if the issue occurs.

Device

Spot Vision Screener 100 with software version up to and including 3.0.01.07
  • Modelo / Serial
    Spot Vision Screener 100 with software version up to and including 3.0.01.07Model Number: Model VS100ARTG Number: 293205Welch Allyn Australia - Visual function analyser
  • Manufacturer
    Welch Allyn Australia Pty Limited

Manufacturer

Welch Allyn Australia Pty Limited