Events

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

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
    21592
  • Clase de Riesgo del Evento
    III
  • Fecha de inicio del evento
    2012-08-27
  • 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
    During centricity to centricity exam transfer a potential image loss can occur while images are being transferred from the source to destination server. when another process in the destination server attempts to access the same object or table the transfer process of a particular image may be terminated. once terminated the transfer service skips the image being sent and continues to send the next image in the exam.

Device

CENTRICITY PACS WORKSTATION - SOFTWARE
  • Modelo / Serial
    Model Catalog: K2034W (Lot serial: >10 numbers contact mfg); Model Catalog: K2033LG (Lot serial: >10 numbers contact mfg); Model Catalog: K2033L (Lot serial: >10 numbers contact mfg); Model Catalog: CENTRICITY PACS 3.1.1.1 (Lot serial: >10 numbers contact mfg); Model Catalog: K2022PF (Lot serial: >10 numbers contact mfg); Model Catalog: K2022PE (Lot serial: >10 numbers contact mfg); Model Catalog: K2033JS (Lot serial: >10 numbers contact mfg)
  • Descripción del producto
    CENTRICITY PACS SYSTEM
  • Manufacturer
    GENERAL ELECTRIC CANADA (OPERATING AS GE HEALTHCARE)

Manufacturer

GENERAL ELECTRIC CANADA (OPERATING AS GE HEALTHCARE)