Retiro De Equipo (Recall) de ACUSON S Family Ultrasound Systems utilising the 18L6 HD and/or 6C1 HD biopsy guidelines

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-2015-RN-00609-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2015-07-07
  • País del evento
  • Fuente del evento
    DHTGA
  • URL de la fuente del evento
  • 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
    This issue occurs when using the civco biopsy attachments in combination with the acuson s family on-screen guidelines. the biopsy needle may traverse outside the on-screen guidelines. this occurs on the 6c1 hd and 18l6 hd transducers. the potential risk is the tissue of interest may not get sampled. to date, no patient injury has been reported.
  • Acción
    To avoid this issue, users are advised not to use the 6C1 HD and 18L6 HD with the CIVCO biopsy attachments for guided biopsy procedures. For guided procedures with other transducers, users are advised that they must verify that the path of the needle is accurately indicated by the on-screen guidelines. The needle guide is ready for patient use only after the path of the needle has been verified. Also, users are reminded of the following warnings: - The biopsy guidelines that display on the system monitor are not intended as an absolute reference. It is the user's responsibility to verify correct positioning of the needle during a biopsy or puncture procedure. - Do not use a needle guide if the path of the needle is not accurately indicated by the on-screen guidelines. The path of the needle must display within the guideline. Users are advised to contact their Siemens service representative if the needle path is not accurately indicated.

Device

  • Modelo / Serial
    ACUSON S Family Ultrasound Systems utilising the 18L6 HD and/or 6C1 HD biopsy guidelinesCatalogue numbers – 10041461, 10441701, 10441730ARTG Number: 137563
  • Manufacturer

Manufacturer

  • Empresa matriz del fabricante (2017)
  • Source
    DHTGA