Events

Retiro De Equipo (Recall) de SECURVIEW DX DIAGNOSTIC WORKSTATION

Según Health Canada (via FOI), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Canada que fue producido por CHRISTIE INNOMED 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
    82892
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2012-03-01
  • 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
    Two problems related to hologic released sofware 7.3.0 were reported: (1). measurements made on tomosynthesis images in a quadruple tiling mode will not have the correct value when displayed in other modes. and (2). annotations (gsps) made on tomosynthesis images may have incorrect placement on images if the annotations were made on images that were flipped from their original orientation.

Device

SECURVIEW DX DIAGNOSTIC WORKSTATION
  • Modelo / Serial
    Model Catalog: SVDX-00400 (Lot serial: 3980109B0672); Model Catalog: SVDX-00600 (Lot serial: 2981208B2456); Model Catalog: SVDX-00300 (Lot serial: 2981208B2456); Model Catalog: SVDX-00400 (Lot serial: 2981208B2456); Model Catalog: SVDX-00600 (Lot serial: 2980908B2284); Model Catalog: SVDX-00300 (Lot serial: 2980908B2284); Model Catalog: SVDX-00400 (Lot serial: 2980908B2284); Model Catalog: SVDX-00600 (Lot serial: 2981208B2443); Model Catalog: SVDX-00300 (Lot serial: 2981208B2443); Model Catalog: SVDX-00400 (Lot serial: 2981208B2443); Model Catalog: SVDX-00600 (Lot serial: 3961208B0414); Model Catalog: SVDX-00300 (Lot serial: 3961208B0414); Model Catalog: SVDX-00400 (Lot serial: 3961208B0414); Model Catalog: SVDX-00600 (Lot serial: 2961208B0413); Model Catalog: SVDX-00300 (Lot serial: 2961208B0413); Model Catalog: SVDX-00400 (Lot serial: 2961208B0413); Model Catalog: SVDX-00600 (Lot serial: 3980109B0672); Model Catalog: SVDX-00300 (Lot serial: 3980109B0672)
  • Descripción del producto
    SecurView DX and RT
  • Manufacturer
    CHRISTIE INNOMED INC.

Manufacturer

CHRISTIE INNOMED INC.
  • Dirección del fabricante
    ST-EUSTACHE
  • Empresa matriz del fabricante (2017)
    Groupe Christie Inc
  • Source
    HC