Events

Retiro De Equipo (Recall) de Hettich Centrifuge Bucket Model 4464-R. An in vitro diagnostic medical device (IVD)(used on StreamLAB Centrifuges, Aptio Centrifuges, FlexLab High Throughput Centrifuges and FlexLab)

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Siemens Healthcare 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-2016-RN-00663-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2016-05-23
  • 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-2016-RN-00663-1
  • 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
    Siemens healthcare diagnostics is issuing an urgent recall for product correction notice for the hettich centrifuge buckets (model 4464-r) of affected hettich rotanta 46 rsc robotic and rotanta 460 robotic centrifuges. hettich, the centrifuge manufacturer is currently investigating the reason for premature bucket failures. there is the possibility that material changes may have an impact of the strength of the buckets. when the hettich centrifuge bucket fails during centrifugation, the potential exists for a delay in patient testing and the potential for movement/rotation of the centrifuge.
  • Acción
    Siemens is providing users with instructions to conduct a weekly check of centrifuge buckets for signs of cracking and replace if required. Additionally, the maximum RPM should be reduced to 3,500 rpm.

Device

Hettich Centrifuge Bucket Model 4464-R. An in vitro diagnostic medical device (IVD)(used on Strea...
  • Modelo / Serial
    Hettich Centrifuge Bucket Model 4464-R. An in vitro diagnostic medical device (IVD)(used on StreamLAB Centrifuges, Aptio Centrifuges, FlexLab High Throughput Centrifuges and FlexLab)Model Number: 4464-RMultiple model numbers of affected centrifuges ARTG Numbers: 174699, 238361
  • Manufacturer
    Siemens Healthcare Pty Ltd

Manufacturer

Siemens Healthcare Pty Ltd
  • Empresa matriz del fabricante (2017)
    Siemens AG
  • Source
    DHTGA