Events

Retiro De Equipo (Recall) de UNICEL DXC 600

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

¿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
    71085
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2016-06-28
  • 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
    Beckman coulter has identified an incompatibility between no foam dxc reagent (ref b64130) and the dxc hydropneumatic parts associated with no foam delivery. dxc no foam reagent is intended to prevent formation of foam and/or bubbles in the dxc waste system of the hydropneumatic subsystems. over time this incompatibility may lead to: breaks in no foam cap assembly (pn a84827) cracks in no foam waste collector (pn a60007/a64665) seepage outside no foam tubing (pn's a10027 a10028 and a67123). this incompatibility does not affect no foam's ability to perform its function and there is no impact to patient results. cracks in the waste collector may stop instrument operation due to vacuum error and potentially lead to biohazardous waste exposure. cracks in the no foam cap and seepage from the no foam tubing may lead to exposure to no foam.

Device

UNICEL DXC 600
  • Modelo / Serial
    Model Catalog: 4764 (Lot serial: ALL); Model Catalog: 4772 (Lot serial: ALL); Model Catalog: 4773 (Lot serial: ALL); Model Catalog: 4767 (Lot serial: ALL); Model Catalog: 4771 (Lot serial: ALL); Model Catalog: 4768 (Lot serial: ALL); Model Catalog: B64130 (Lot serial: ALL)
  • Descripción del producto
    UNICEL DXC 600 SYNCHRON CLINICAL SYSTEMS;UNICEL DXC 680I SYNCHRON ACCESS INTEGRATED CLINICAL SYSTEMS;UNICEL DXC 860I SYNCHRON ACCESS INTEGRATED CLINICAL SYSTEMS;UNICEL DXC 600I SYNCHRON ACCESS INTEGRATED CLINICAL SYSTEMS;UNICEL DXC 800 SYNCHRON CLINICAL S
  • Manufacturer
    BECKMAN COULTER CANADA L.P.

Manufacturer

BECKMAN COULTER CANADA L.P.
  • Dirección del fabricante
    MISSISSAUGA
  • Empresa matriz del fabricante (2017)
    Danaher Corporation
  • Source
    HC