Events

Retiro De Equipo (Recall) de Stereo Biopsy Device used with Mammomat Inspiration Mammography SystemMaterial number: 10140000 (Mammomat Inspiration)

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-01040-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2014-09-25
  • 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-01040-1
  • 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
    The stereo biopsy devices for mammomat inspiration mammography systems might have integrated a safety switch which causes a failure of the functionality. the pin implemented in the safety switch may not put enough pressure on the safety circuit to prohibit movement. the needle positioning device may move even with the safety switch being set sideward. if this occurs with the needle being already inserted, it could lead to an unintentional patient injury.
  • Acción
    Customers are advised that in case the needle holder moves unintentionally to press the emergency stop. Siemens is recommending inspection of the safety switch before every biopsy until the problem is solved. Siemens is preparing a modification of the safety switch that will resolve this potential malfunction. The field modification will be available beginning of October. This action has been closed-out on 07/06/2016.

Device

Stereo Biopsy Device used with Mammomat Inspiration Mammography SystemMaterial number: 10140000 (...
  • Modelo / Serial
    Stereo Biopsy Device used with Mammomat Inspiration Mammography SystemMaterial number: 10140000 (Mammomat Inspiration) Serial numbers: 1541, 2082ARTG number: 144223
  • Manufacturer
    Siemens Ltd

Manufacturer

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