Events

Retiro De Equipo (Recall) de STERIS FINE TRACTION DEVICE

Según Health Canada (via FOI), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Canada que fue producido por STERIS CANADA INCORPORATED.

¿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
    96428
  • Clase de Riesgo del Evento
    III
  • Fecha de inicio del evento
    2013-06-04
  • 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
    The fine traction device is used to provide traction and enable fine adjustments to traction and orientation of the leg during orthopedic procedures. it is an accessory to the ot1000 series orthopedic surgical tables. steris has learned that the fine traction hand crank and rotation unlock button may lock up causing the fine traction adjustment of this accessory to be inoperable. steris has received no reports of illness or injuries one delay prior to the start of a procedure requiring the patient to be transferred to another surgical table to perform the procedure.

Device

STERIS FINE TRACTION DEVICE
  • Modelo / Serial
    Model Catalog: 10009177 (Lot serial: S/N: 0409813100); Model Catalog: 10009177 (Lot serial: S/N: 0409813097)
  • Descripción del producto
    STERIS FINE TRACTION DEVICE
  • Manufacturer
    STERIS CANADA INCORPORATED

Manufacturer

STERIS CANADA INCORPORATED
  • Dirección del fabricante
    MISSISSAUGA
  • Empresa matriz del fabricante (2017)
    Steris Plc
  • Source
    HC