Events

Retiro De Equipo (Recall) de ACUSON S2000 and ACUSON S3000 Ultrasound Systems (software version VC25) or with HELX Evolution (software version VC30A)

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-00563-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2014-05-29
  • 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-00563-1
  • 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 9l4 transducer in combination with virtual touch quantification (vtq), the displayed mechanical index (ie, the ml value which reflects the risk of mechanical cavitation that could cause tissue damage) may be outside the stated tolerance of +/=15%. this occurs only between the depths of 2.5cm and 3.4cm. to date, no patient injury has been reported.
  • Acción
    Users are advised that the MI values should be interpreted as relative information and used only to assist the operators in implementing the ALARA (As Low As Reasonably Achievable) principle during patient examinations. For systems with software version VC25, Siemens is updating the Instructions for Use regarding the tolerance of the Mechanical Index (MI) displayed values. For systems with software version VC30A, Siemens is updating the software. This action has been closed-out on 18/02/2016.

Device

ACUSON S2000 and ACUSON S3000 Ultrasound Systems (software version VC25) or with HELX Evolution (...
  • Modelo / Serial
    ACUSON S2000 and ACUSON S3000 Ultrasound Systems (software version VC25) or with HELX Evolution (software version VC30A)Catalogue numbers: 10041461, 10440017 and 10441730ARTG Number: 137563
  • Manufacturer
    Siemens Ltd

Manufacturer

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