Events

Retiro De Equipo (Recall) de Siemens syngo RT Therapist COHERENCE RTT Application Software

Según New Zealand Medicines and Medical Devices Safety Authority, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en New Zealand que fue producido por Siemens AG.

¿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
    20518
  • Fecha de inicio del evento
    2016-08-17
  • País del evento
    New Zealand
  • Fuente del evento
    NZMMDSA
  • URL de la fuente del evento
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notas / Alertas
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
  • Notas adicionales en la data
    Recalling Organisation: Siemens Healthcare (NZ) Ltd, Millennium Centre, Part Level 2, Building A, 600 Great South Road, Ellerslie, AUCKLAND 1051
  • Causa
    New software update that addresses multiple issues including an issue communicated earlier:, 1. incorrect isocenter assignment when using multiple treatment plans with different isocenters based on one single planning ct and when a cbct has been acquired for each isocenter, 2.When auto field-sequencing (afs) is selected the pause is no longer present when treating a plan containing at least two beams with different isocentric table angles, 3. table movement due to different isocenters in imaging beams and treatment beams, 4. reference image has been associated to the wrong patient, 5.Incorrect calculated isocenter shift when using late resumption after interruption after beam 1 has been completed, 6.Multiple isocenter in session resumption f1 abort workflow is incorrect, 7. irrevocable assignment of the first reference 2d image, 8. after reverting plan changes in ois mosaiq changes performed on rt therapisttm become inactive.
  • Acción
    Software to be upgraded

Device

Siemens syngo RT Therapist COHERENCE RTT Application Software
  • Modelo / Serial
    Model: , Affected: , Software version: 4.2.110 or 4.3.SP1 or 4.3.138 or 4.3.1_AR1 or 4.3.1_MR2 in combination with Oncology Information System ARIA (by VARIAN) or MOSAIQ (by ELEKTA Inc.)
  • Manufacturer
    Siemens AG

Manufacturer

Siemens AG
  • Empresa matriz del fabricante (2017)
    Siemens AG
  • Source
    NZMMDSA