Events

Retiro De Equipo (Recall) de Biograph mMR with software version syngo E11P

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-2018-RN-00113-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2018-02-06
  • 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-2018-RN-00113-1
  • 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 been notified by the manufacturer that a mismatch has been identified between orientation labels and displayed anatomy (e.G. in the 3d task card) within the software version syngo e11p. this will lead to wrong attenuation correction of the pet data.The issue occurs when changing the image numbering in transversal mrac protocol (e.G. mrac_caipi_hires protocol) from the default setting "feet>>head" to a customised setting "head>>feet". the original images are labelled correctly, but the composed images are flipped by 180 degrees and shifted.There have been no injuries reported as a result of this issue.
  • Acción
    Siemens is advising that this issue will be corrected in the next service pack syngoE11P-SP03. In the interim, do not change the numbering of images in transversal MRAC protocols (within an MRPET workflow). Follow the user manual. Don't rely only on composed images; always additionally refer to the original images for diagnostic purposes.

Device

Biograph mMR with software version syngo E11P
  • Modelo / Serial
    Biograph mMR with software version syngo E11PCatalogue Number:10433372ARTG Number: 274035
  • Manufacturer
    Siemens Healthcare Pty Ltd

Manufacturer

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