Events

Retiro De Equipo (Recall) de Siemens e.cam Systems (Nuclear medicine gamma camera)

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-00657-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2015-07-17
  • 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-2015-RN-00657-1
  • 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 received a report of unintended detector motion. the cause of this motion was determined to be the simultaneous failure of two components, the radial brake circuit and touch pad. this unique combination of failures caused the axis brake to be ineffective, which ultimately led to the detector motion. additionally, activating the emergency stop (e-stop) or a system power failure, between 0.05 and 0.1 seconds after initiating motion could lead to this failure. siemens has determined that the likelihood that these events would occur over such a small time window is extremely rare. the most likely condition that could lead to a rapid power cycling is a touch pad failure. there have been no reports of injury as a result of this issue; however, it is remotely possible that a compression injury to the patient could occur.
  • Acción
    -PRODUCT CORRECTION Siemens has designed and will install an improved brake control circuit which will correct this condition. Users are advised that the e-stop should still be used confidently and they can continue to use their system with confidence while waiting for the repair to be scheduled and performed. Users are reminded that daily touch test and/or its failure should not be ignored. If they experience difficulty or a failure while performing the daily touch pad test, discontinue use and contact their local service representative. This action has been closed-out on 05/09/2016.

Device

Siemens e.cam Systems (Nuclear medicine gamma camera)
  • Modelo / Serial
    Siemens e.cam Systems (Nuclear medicine gamma camera) Multiple catalogue numbers installed prior to December 31st 2004 affectedPart numbers: 4380213, 4380221, 5242826, 5977066, 5989079, 5991109, 5992099, 7324143, 7823946, 7823953. ARTG number: 186317
  • Clasificación del producto
    Radiology Devices
  • Manufacturer
    Siemens Healthcare Pty Ltd

Manufacturer

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