Events

Retiro De Equipo (Recall) de syngo RT Therapist 4.3.SP1 or 4.3.138 or 4.3.1_AR1 or 4.2.110 in combination with Oncology Information System (OIS), MOSAIQ

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-01088-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2016-08-23
  • 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-2016-RN-01088-1
  • 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
    Syngo rt therapist is specified in a way that it will always use the plan unique identifier (uid provided by ois mosaiq. if a plan has changed many times and one of the previous changes is reverted, mosaiq will apply the uid of the previous plan, before the change has been made in the past. in this case, from a treatment point of view mosaiq sends a previously used plan uid that may cause the rt therapist to choose an out-dated treatment plan according to the plan uid provided by mosaiq. as a consequence all performed changes on rt therapist, for example setup changes like added pauses or gating flags, will not be active. this behaviour might lead to a collision or a mistreatment.
  • Acción
    Siemens has notified users that from a syngo RT Therapist software point of view, it is not possible to distinguish between correct and incorrect UID provided by MOSAIQ. Therefore no technical solution for this issue can be provided by Siemens. The “RT Therapist Release Notes for MOSAIQ” have been updated with the according information in chapter 10.1. This action has been closed out on 16 June 2017.

Device

syngo RT Therapist 4.3.SP1 or 4.3.138 or 4.3.1_AR1 or 4.2.110 in combination with Oncology Inform...
  • Modelo / Serial
    syngo RT Therapist 4.3.SP1 or 4.3.138 or 4.3.1_AR1 or 4.2.110 in combination with Oncology Information System (OIS), MOSAIQCatalogue Numbers: 8162815 and 8168754ARTG Number: 171515
  • Manufacturer
    Siemens Healthcare Pty Ltd

Manufacturer

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