Events

Retiro De Equipo (Recall) de ACUSON SC2000 System (Ultrasound cardiovascular imaging system) when used with V5M Transducer (which includes revision 4 of the MPI board)

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 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-2013-RN-00325-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2013-04-24
  • 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-2013-RN-00325-1
  • 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
    When using the v5m transducer, the display of the temperature on the acuson sc2000 system can be lower than the actual temperature of the v5m transducer. this occurs only if the system hardware contains revision 4 of the mpi board. if this condition occurs when scanning a febrile or hyperthermic patient using maximum system power settings (0 db), the actual lens surface temperature could exceed 43degc while the system temperature display continues to show a value under 43degc. there is a potential to cause oesophageal burns in patients with body temperatures greater than 40degc.Products supplied in australia include a different transducer (4z1c) which cannot be used for trans-oesophageal imaging. potential for heating with this model is mitigated by independent mechanical cooling which is not dependent on a feedback mechanism. siemens is correcting all models including revision 4 of the mpi board irrespective of the transducer version.
  • Acción
    Siemens is providing temporary work around instructions and is implementing an upgrade of the system hardware that will correct the issue.

Device

ACUSON SC2000 System (Ultrasound cardiovascular imaging system) when used with V5M Transducer (wh...
  • Modelo / Serial
    ACUSON SC2000 System (Ultrasound cardiovascular imaging system) when used with V5M Transducer (which includes revision 4 of the MPI board)ARTG Number: 139591
  • Manufacturer
    Siemens Ltd

Manufacturer

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