Events

Retiro De Equipo (Recall) de FLOOR MOUNTING COLUMN JUPITER U

Según Health Canada (via FOI), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Canada que fue producido por OLYMPUS CANADA 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
    26971
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2014-12-23
  • 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
    Manufacturer has become aware of unintended movement occurring during surgical cases due to the use of damaged remotes. no patients or users have been injured. there is a possibility that damage can occur to a remote control which breaks the button and can cause permanent or sporadic electrical conduction and trigger unintended movement. this is a rare event and can be avoided by proper handling and maintenance of the remote control. the product is safe as long as it is not damaged.

Device

FLOOR MOUNTING COLUMN JUPITER U
  • Modelo / Serial
    Model Catalog: 1276277 (Lot serial: All Lots); Model Catalog: 4500112 (Lot serial: All Lots); Model Catalog: 4500113 (Lot serial: All Lots); Model Catalog: 1574977 (Lot serial: All Lots); Model Catalog: 4500170 (Lot serial: All Lots); Model Catalog: 1389826 (Lot serial: All Lots); Model Catalog: 1622774 (Lot serial: All Lots); Model Catalog: 1223188 (Lot serial: All Lots); Model Catalog: 1389824 (Lot serial: All Lots)
  • Descripción del producto
    FLOOR MOUNTING COLUMN JUPITER U
  • Manufacturer
    OLYMPUS CANADA INC.

Manufacturer

OLYMPUS CANADA INC.
  • Dirección del fabricante
    RICHMOND HILL
  • Empresa matriz del fabricante (2017)
    Olympus Corporation
  • Source
    HC