Events

Retiro De Equipo (Recall) de CENTRICITY PACS WORKSTATION - HARDWARE

Según Health Canada (via FOI), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Canada que fue producido por GENERAL ELECTRIC CANADA (OPERATING AS GE HEALTHCARE).

¿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
    22491
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2008-11-07
  • 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
    1)a forced log off may occur during an open session 2)centricity enterprise web does not utilize calibration performed on image measurements in centricity ra1000 workstation.

Device

CENTRICITY PACS WORKSTATION - HARDWARE
  • Modelo / Serial
    Model Catalog: P0001L (Lot serial: 519646AIMB 519685TESTAIM); Model Catalog: K2080PN (Lot serial: 519646AIMB 519685TESTAIM); Model Catalog: K2033KK (Lot serial: 519646AIMB 519685TESTAIM); Model Catalog: P0001L (Lot serial: 416360CVPACS 519685AIMA); Model Catalog: K2033KK (Lot serial: S/N'S USE835NAJK 905895DIEA); Model Catalog: K2033KK (Lot serial: 416360CVPACS 519685AIMA); Model Catalog: P0001L (Lot serial: S/N'S USE835NAJK 905895DIEA); Model Catalog: K2080PN (Lot serial: S/N'S USE835NAJK 905895DIEA); Model Catalog: K2080PN (Lot serial: 416360CVPACS 519685AIMA); Model Catalog: P0001KA (Lot serial: s/n USE824N5BV 905895DIEA); Model Catalog: P0001KA (Lot serial: 416360CVPACS); Model Catalog: K2033KL (Lot serial: 416360CVPACS); Model Catalog: P0001KC (Lot serial: 416360CVPACS); Model Catalog: K2033KL (Lot serial: s/n USE824N5BV 905895DIEA); Model Catalog: P0001KC (Lot serial: s/n USE824N5BV 905895DIEA); Model Catalog: K2034JP (Lot serial: >10 NUMBERS); Model Catalog: K2034JP (Lot serial: CONTACT); Model Catalo
  • Descripción del producto
    CENTRICITY PACS WORKSTATION - HARDWARE
  • Manufacturer
    GENERAL ELECTRIC CANADA (OPERATING AS GE HEALTHCARE)

Manufacturer

GENERAL ELECTRIC CANADA (OPERATING AS GE HEALTHCARE)