Retiro De Equipo (Recall) de C-300 FIXED CEILING LIFT

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

¿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
    16796
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2015-10-20
  • País del evento
  • 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
    Prism medical canada has been made aware of a number of incidents globally involving 300 series lifts in which the drive gear shaft has broken eliminating the lifts ability to raise or lower a client. of these incidents we have discovered very few cases in which the free fall protection system did not engage properly. if both of these incidents occur at the same time there is a risk for the person being supported by the lift to drop unexpectedly.

Device

  • Modelo / Serial
    Model Catalog: 330057 (Lot serial: all lots); Model Catalog: 330053R (Lot serial: all lots); Model Catalog: 330050 (Lot serial: all lots); Model Catalog: 330050R (Lot serial: all lots); Model Catalog: 330053 (Lot serial: all lots); Model Catalog: 303050 (Lot serial: all lots); Model Catalog: 303050R (Lot serial: all lots); Model Catalog: 303051 (Lot serial: all lots)
  • Descripción del producto
    C-300 FIXED CEILING LIFT
  • Manufacturer

Manufacturer

  • Dirección del fabricante
    CONCORD
  • Empresa matriz del fabricante (2017)
  • Source
    HC