Events

Retiro De Equipo (Recall) de SERVER SOFTWARE

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
    32765
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2014-04-14
  • 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
    A potential issue when using "in-progress" invasive reporting with sensis integration to syngo dynamics v9.5. the issue occurs under the following conditions: - sensis-syngo dynamics integration - sensis study is opened from syngo dynamics while still "in-progress" - sensis reference numbers > 1000000 -sensis reference numbers grow in response to hl7 messages even if those hl7 messages are not being utilized by sensis and/or syngo dynamics. sensis reference number greater than 1000000 are wrongly modified during transfer to syngo dynamics. when this happens during "in-progress" reporting a study will get a sensis reference number for the wrong study in sensis. this causes an incorrect 'link' between the syngo dynamics images and the sensis study data. if this happens customers will have to call siemens service team. there has not been any patient consequence reported from the installed base.

Device

SERVER SOFTWARE
  • Modelo / Serial
    Model Catalog: 10091862 (Lot serial: S/N 85162); Model Catalog: 10091863 (Lot serial: S/N 85182)
  • Descripción del producto
    SERVER SOFTWARE
  • Manufacturer
    SIEMENS HEALTHCARE LIMITED

Manufacturer

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