Events

Retiro De Equipo (Recall) de ACUSON S Family ultrasound systems with software versions VD10A or VD10C when using 18L6 HD transducer

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-2017-RN-00478-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2017-04-19
  • 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-2017-RN-00478-1
  • 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 has identified a potential issue with the 18l6 hd transducer on the acuson s family ultrasound systems (with software versions vd10a or vd10). when scanning with the 18l6 transducer on the acuson helx evolution with touch control, the ultrasound system may display a triple image or an image with a dark band. when the triple image issue occurs, the system repeats one-third of the aperture, but does not display the full field of view. the issue occurs intermittently when connecting the 18l6 hd transducer to the ultrasound system or when selecting the touch screen control to activate the transducer. the potential risk is specific to breast exams and the possibility of not visualising lesions when acquiring images of breast tissue, which may result in a misdiagnosis.
  • Acción
    Siemens is recommending users perform the following steps before using the18L6 HD transducer: Connect the transducer to the ultrasound system and place a gel-coated fingertip on the transducer face. Drag the finger along the entire face of the transducer and if the echo from the finger displays in triplicate, disconnect and reconnect the transducer. Then repeat the test. It is recommended that users review any breast studies performed with an affected device to confirm no triple images were used as part of a diagnosis. Siemens is advising users that steps have been taken to resolve the issue with a software release.

Device

ACUSON S Family ultrasound systems with software versions VD10A or VD10C when using 18L6 HD trans...
  • Modelo / Serial
    ACUSON S Family ultrasound systems with software versions VD10A or VD10C when using 18L6 HD transducerCatalogue Numbers: S1000 – 10441701S2000 – 10041461S2000 (Refurbished) – 10440017S3000 – 1044173018L6 HD Transducer - 10041227 & 10789400ARTG Number: 137563
  • Manufacturer
    Siemens Healthcare Pty Ltd

Manufacturer

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