Events

Retiro De Equipo (Recall) de Arthrex and Andreas Hettich Rotofix 32A Centrifuge, An in vitro diagnostic medical device (IVD)

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Device Technologies 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-2012-RN-00929-1
  • Clase de Riesgo del Evento
    Class III
  • Fecha de inicio del evento
    2012-09-12
  • 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-2012-RN-00929-1
  • 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
    It has been identified that affected serial numbers may be able to be opened during centrifugation due to a manufacturing fault of the upper parts, resulting in affected units will have a higher bending edge (i.E. the hole for the emergency release pin is lower than it should be).
  • Acción
    Customers to inspect all units as per the instructions provided in the recall notice and isolate any affected units. Sponsor will replace upper housing of affected centrifuges.

Device

Arthrex and Andreas Hettich Rotofix 32A Centrifuge, An in vitro diagnostic medical device (IVD)
  • Modelo / Serial
    Arthrex and Andreas Hettich Rotofix 32A Centrifuge, An in vitro diagnostic medical device (IVD)Product Code: ABS-10020Serial numbers: 14843 to 15070 and 15360 to 15559
  • Manufacturer
    Device Technologies Australia Pty Ltd

Manufacturer

Device Technologies Australia Pty Ltd