Events

Retiro De Equipo (Recall) de Artis Systems running Artis VC1x software (Fluoroscopic angiographic diagnostic x-ray 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 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-2013-RN-00966-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2013-09-13
  • 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-2013-RN-00966-1
  • 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
    Under certain conditions, x-ray release on artis system version vc1x may get blocked. thepotential malfunction may only occur if:a) the system is ready for operation, andb) the c-arm was moved into the so called "patient transfer position" for patient transfer (in this position x-ray is blocked), andc) at the same time the c-arm is in "patient transfer position", a hardware failure in the ias (image acquisition system) is occurring.If the c-arm is moved out of the "patient transfer position" (the problem with the ias was solved by the system itself), x-ray remains blocked.This issue is known to have only occurred on a single system in the field.
  • Acción
    If the failure mode occurs, customers are advised to urgently manually switch the system OFF ("System shutdown") then switch the system back ON again. The failure mode cannot be generally rectified by either executing the "System Restart" or "Application Restart" functions. The supplement to the Operator Manual with the above information is enclosed with the customer letters. The problem will be resolved during the next service update.

Device

Artis Systems running Artis VC1x software (Fluoroscopic angiographic diagnostic x-ray system)
  • Modelo / Serial
    Artis Systems running Artis VC1x software (Fluoroscopic angiographic diagnostic x-ray system)ARTG Number: 102177
  • Manufacturer
    Siemens Ltd

Manufacturer

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