Events

Retiro De Equipo (Recall) de C-SERIES CARRY BAR

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
    44705
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2016-09-16
  • 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
    C-series carry bar have separated from the lift strap due to the metal strap pin breaking the black plastic puck and pulling through the top plate. this breaking has been linked to users not performing pre-use monthly & bi-annual inspections of their lifting equipment as specified in all prism medical user manuals. the black plastic puck does not support the weight of the client but instead acts as a swivel and washer that is sandwiched between the metal carry bar top plate and metal strap pin. they are not aware of any defects that will/may cause the black plastic puck to break unexpectedly.

Device

C-SERIES CARRY BAR
  • Modelo / Serial
    Model Catalog: 360757 (Lot serial: n/a); Model Catalog: 360756 (Lot serial: n/a); Model Catalog: 360755 REV B (Lot serial: n/a); Model Catalog: 360741 (Lot serial: n/a); Model Catalog: 360751 (Lot serial: n/a); Model Catalog: 360750 (Lot serial: n/a); Model Catalog: 360755 (Lot serial: n/a)
  • Descripción del producto
    C-SERIES CARRY BAR
  • Manufacturer
    PRISM MEDICAL LTD

Manufacturer

PRISM MEDICAL LTD
  • Dirección del fabricante
    CONCORD
  • Empresa matriz del fabricante (2017)
    Prism Medical Ltd.
  • Source
    HC