Events

Retiro De Equipo (Recall) de ACUSON S Family Ultrasound Systems with software versions VC25D, VC30A, VC30B

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-2014-RN-00657-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2014-06-23
  • 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-2014-RN-00657-1
  • 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
    A potential measurement error may occur in all exams (except cardiac) when using the auto-stats tool or the velocity tool during live imaging and when adjusting one of the following parameters with the auto-stats tool enabled:- changing the transmit frequency of the active transducer using the pw multihz control. - adjusting the position of the spectral baseline using the baseline control.- adjusting the pulsed repetition frequency (prf) using the scale control. during system freeze, the measured results indicate the scale values prior to adjustment of any of the above parameters. as a result, the measurements and/or calculations will be incorrect. to date, no patient injury has been reported as a result of this issue.
  • Acción
    Siemens is advising operators that the issue can be avoided by not using the Auto-Stats tool and to only use the Velocity tool on frozen images. A Siemens service engineer will be in contact to update to software to correct the issue. Users are advised that a look back at previously reported results should be considered at the discretion of the clinician. Thia action has been closed-out on 28/01/2016.

Device

ACUSON S Family Ultrasound Systems with software versions VC25D, VC30A, VC30B
  • Modelo / Serial
    ACUSON S Family Ultrasound Systems with software versions VC25D, VC30A, VC30BARTG Number: 137563
  • Clasificación del producto
    Radiology Devices
  • Manufacturer
    Siemens Ltd

Manufacturer

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