Events

Retiro De Equipo (Recall) de LIGHTSPEED 16 CT SCANNER SYSTEM

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
    46563
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2016-01-26
  • 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
    Gehc has updated the service manuals used to maintain these scanners to fix an incorrect torque value which is the source of the field action. fmi 25463 identified a torque issue with 5 volt supplies in ct and pet lightspeed systems and corrected the issue by field action as well as a technical manual update. this recall is to send a second customer letter to anyone who may still possess and use an obsoleted service manual.

Device

LIGHTSPEED 16 CT SCANNER SYSTEM
  • Modelo / Serial
    Model Catalog: B7868JA (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: S9118JS (Lot serial: 00000348810CN3); Model Catalog: S9118JS (Lot serial: 00000349405CN1)
  • Descripción del producto
    LIGHTSPEED 16 CT SCANNER SYSTEM
  • Manufacturer
    GENERAL ELECTRIC CANADA (OPERATING AS GE HEALTHCARE)

Manufacturer

GENERAL ELECTRIC CANADA (OPERATING AS GE HEALTHCARE)