Events

Retiro De Equipo (Recall) de SYNGO.VIA

Según Health Canada (via FOI), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Canada que fue producido por SIEMENS HEALTHCARE LIMITED.

¿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
    98371
  • Clase de Riesgo del Evento
    III
  • Fecha de inicio del evento
    2018-01-11
  • País del evento
    Canada
  • Fuente del evento
    HC
  • Notas / Alertas
    Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
  • Notas adicionales en la data
  • Causa
    The manufacturer has identified a limitation within the syngo.Via vb20a reporting sections. after entering the findings information using the findings assistant or the interactive findings dialogue (ifd) user may check the finding information within the report. in case a correction of finding information should be needed user does the correction in "findings information" section or "summary of measured findings" section. in vb20a versions listed this feature is not working as expected: the corrected values modified in the report are neither saved nor printed nor sent to information system. the system will still use the former values. if the late modifications done on the syngo.Via evidence report are not noticed later when creating the formal report in the reporting system outdated information could be sent to the referring physician.

Device

SYNGO.VIA
  • Modelo / Serial
    Model Catalog: 10496180 (Lot serial: 101689); Model Catalog: 10496180 (Lot serial: 101928); Model Catalog: 10496180 (Lot serial: 101568); Model Catalog: 10496180 (Lot serial: 101386); Model Catalog: 10496180 (Lot serial: 109939); Model Catalog: 10496180 (Lot serial: 101075); Model Catalog: 10496180 (Lot serial: 131196); Model Catalog: 10496180 (Lot serial: 101414); Model Catalog: 10496180 (Lot serial: 101401); Model Catalog: 10496180 (Lot serial: 130766); Model Catalog: 10496180 (Lot serial: 101511); Model Catalog: 10496180 (Lot serial: 131273); Model Catalog: 10496180 (Lot serial: 130294); Model Catalog: 10496180 (Lot serial: 222377); Model Catalog: 10496180 (Lot serial: 102241); Model Catalog: 10496180 (Lot serial: 130666)
  • Descripción del producto
    SYNGO.VIA
  • Manufacturer
    SIEMENS HEALTHCARE LIMITED

Manufacturer

SIEMENS HEALTHCARE LIMITED
  • Dirección del fabricante
    OAKVILLE
  • Empresa matriz del fabricante (2017)
    Siemens Ag
  • Source
    HC