Events

Retiro De Equipo (Recall) de Endoscan Brush Purple

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Thermo Fisher Scientific Australia 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-2018-RN-00661-1
  • Clase de Riesgo del Evento
    Class III
  • Fecha de inicio del evento
    2018-05-31
  • 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-2018-RN-00661-1
  • 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 is advising of a potential issue with artis pheno systems. during manual rotation of the c-arm at maximum speed, the system's safety stop mechanism may be activated. as a result, the c-arm of artis pheno stops the rotation and can drop up to 40 mm (1.6 "). this can happen during an ongoing procedure. if this problem occurs, the system performs a safety stop. the system can then be operated normally again. under certain circumstances, the cover of the detector or collimator can touch and possibly injure the patient due to the drop caused by this safety stop.
  • Acción
    Thermo Fisher are advising users to inspect stock and quarantine all unused units from lot 20180120. Thermo Fisher will arrange recovery and replacement of impacted stock. Correctly labelled product will be available in the next 3-4 weeks.

Device

Endoscan Brush Purple
  • Modelo / Serial
    Endoscan Brush PurpleCatalogue Number: PMD1013ALot Number: 20180120ARTG Number: 296456(X-ray system, diagnostic, fluoroscopic, angiographic, stationary, digital)
  • Manufacturer
    Thermo Fisher Scientific Australia Pty Ltd

Manufacturer

Thermo Fisher Scientific Australia Pty Ltd