Events

Retiro De Equipo (Recall) de Biograph m CT and Biograph m CT Flow Combination PET/CT

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 Medical Solutions USA Inc.

¿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
    20969
  • Fecha de inicio del evento
    2016-12-21
  • 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
    The manufacturer has become aware, through our supplier that some laser cover windows may fall off. due to the subsequent gantry cover opening, there is a potential for injury if a patient, operator or other person reaches into this gantry opening.
  • Acción
    Manufacturer to issue advice regarding use

Device

Biograph m CT and Biograph m CT Flow Combination PET/CT
  • Modelo / Serial
    Model: , Affected: Lot number: 10248668, 10248669, 10248670, 10248671, 10248672, 10248673, 10250743, 10250745, 10507786, 10528955, 10529159
  • Manufacturer
    Siemens Medical Solutions USA Inc

Manufacturer

Siemens Medical Solutions USA Inc
  • Empresa matriz del fabricante (2017)
    Siemens AG
  • Source
    NZMMDSA