Retiro De Equipo (Recall) de e.cam and Symbia E systems (Nuclear medicine gamma camera system)

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-2016-RN-01052-1
  • Clase de Riesgo del Evento
    Class III
  • Fecha de inicio del evento
    2016-08-10
  • 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
    Siemens has received reports of patients’ hair being caught in the e.Cam and symbia e patient bed up/down drive. siemens is reminding users of the patient positioning instructions for the e.Cam or symbia e systems. additionally, an enhancement kit that reduces the gap in the patient bed up/down drive has been designed and will be installed by siemens.
  • Acción
    Siemens is reminding users of the positioning instructions for the e.cam and Symbia E systems that require operators to properly position the patient and observe the patient at all times. Siemens will be arranging for an enhancement kit to be installed by a Siemens service representative. This action has been closed-out on 23/06/2017.

Device

  • Modelo / Serial
    e.cam and Symbia E systems (Nuclear medicine gamma camera system)Catalogue Numbers: 4380213, 4380221, 5242826, 5977066, 5977074, 5984005, 5989079, 5989087, 5989095, 5991109, 5991117, 5992099, 7324119, 7324135, 7324143, 7324150, 7760809, 7760932, 7761161, 7823920, 7823938, 7823946, 7823953, 7823961, 7823979, 10151531, 10151532, 10275879, 10413009, 10520745ARTG Numbers: 186317, 186317
  • Manufacturer

Manufacturer

  • Empresa matriz del fabricante (2017)
  • Source
    DHTGA