Events

Retiro De Equipo (Recall) de Scherbak Weights – 400 gr and 800 gr (used with Scherbak vaginal speculum)

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Medical & Optical Instruments Australia 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-2014-RN-00944-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2014-09-03
  • 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-2014-RN-00944-1
  • 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
    Medical & optical has been advised by kls martin 400gr and 800gr weights, placed in the market place for the scherbak vaginal speculum, fractures can occur in the laser welded seam between the holding hook and the weight involved.
  • Acción
    Medical & Optical is recalling the affected stock and a replacement of the affected weights will be provided free of charge. This action has been closed-out on 04/04/2017.

Device

Scherbak Weights – 400 gr and 800 gr (used with Scherbak vaginal speculum)
  • Modelo / Serial
    Scherbak Weights – 400 gr and 800 gr (used with Scherbak vaginal speculum)Affected part numbers: Scherbak Weight, 400gr - Art. No. 32-302-10-01Scherbak Weight, 800gr - Art. No. 32-302-12-01Full set: Art. No. 32-302-00-01ARTG number: 177280
  • Manufacturer
    Medical & Optical Instruments Australia Pty Ltd

Manufacturer

Medical & Optical Instruments Australia Pty Ltd