Events

Retiro De Equipo (Recall) de Aptio Automation Modules. 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 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-01310-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2016-10-10
  • 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-01310-1
  • 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
    An issue has been identified with the aptio automation modules. there is a possibility that the plug used to connect the automation system power source may overheat and fail. the plug used to connect to a standard power outlet is not affected.
  • Acción
    Siemens is advising users to review customer letter with Medical Director, ensure all users are aware of the issue, return completed Response Form, retain letter with laboratory records and forward letter to those who may have received product. Siemens Customer Service Engineers shall be visiting customer sites to replace the power cords.

Device

Aptio Automation Modules. An in vitro diagnostic medical device (IVD).
  • Modelo / Serial
    Aptio Automation Modules. An in vitro diagnostic medical device (IVD).Module: Refrigerated Storage ModuleMaterial Number:10703049, 10715227, 10703036, 10713762 and 10713767Module: Centrifuge ModuleMaterial Number: 10703032, 10713761 and 10713764Module: i2000SR Interface ModuleMaterial Number: 10989303 and 10989304ARTG Number: 174699
  • Manufacturer
    Siemens Healthcare Pty Ltd

Manufacturer

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