Events

Retiro De Equipo (Recall) de Siemens Flex Large 4 Coil for MAGNETOM Skyra, Verio, Spectra and Biograph mMR

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
    13497
  • Fecha de inicio del evento
    2012-09-14
  • 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
    Heating may occur if each of the following conditions applies at the same time:, - coil positioned off-center in head-foot direction by more than +/- 5 cm,, - coil at side position, - application of the high rf power over several minutes, in that position , the surface temperature may well exceed temperatures defined by regulatory standards and may cause local burns to the patient.
  • Acción
    Instructions for use to be updated

Device

Siemens Flex Large 4 Coil for MAGNETOM Skyra, Verio, Spectra and Biograph mMR
  • Modelo / Serial
    Model: Part No. 8625761, Affected: All units
  • Manufacturer
    Siemens AG

Manufacturer

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