Events

Retiro De Equipo (Recall) de CELLEX PHOTOPHERESIS SYSTEM

Según Health Canada (via FOI), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Canada que fue producido por ORTHO-CLINICAL DIAGNOSTICS.

¿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
    50380
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2011-09-07
  • 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
    Of 18000 treatments performed to date therakos received three confirmed reports of post reinfusion hemolysis or hemoglobinuria in patients treated on the cellex photopheresis system. the investigation suggests that heat generated in the centrifuge chamber may be responsible for red cell changes that may rarely result in post reinfusion hemolysis or hemoglobinuria. the purpose of the recall notification is to provide customers with recommended actions intended to reduce heat build-up in the centrifuge chamber of the cellex system.

Device

CELLEX PHOTOPHERESIS SYSTEM
  • Modelo / Serial
    Model Catalog: THERAKOS CELLEX (Lot serial: 40138); Model Catalog: THERAKOS CELLEX (Lot serial: 40223); Model Catalog: THERAKOS CELLEX (Lot serial: 40233); Model Catalog: THERAKOS CELLEX (Lot serial: 40234)
  • Descripción del producto
    THERAKOS CELLEX Photopheresis System
  • Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS

Manufacturer

ORTHO-CLINICAL DIAGNOSTICS