Events

Retiro De Equipo (Recall) de DRX-REVOLUTION MOBILE X-RAY SYSTEM

Según Health Canada (via FOI), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Canada que fue producido por CARESTREAM HEALTH 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
    16332
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2017-01-04
  • 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
    Carestream health has identified an issue with the drx-revolution mobile x-ray system that could result in unintended motion. carestream's investigation found that the pivot screws in the drive handle can back out and interfere with the driving mechanism. the backed out screw can interfere with operator control of the drx revolution and result in unintended motion. the investigation revealed that thread locking compound applied in the manufacturing process to secure this screw was not always applied as it should. to date carestream has found only a single system where this failure has occurred there was no resulting injury but the problem could manifest in additional units over the life of the device.

Device

DRX-REVOLUTION MOBILE X-RAY SYSTEM
  • Modelo / Serial
    Model Catalog: 1019397 (Lot serial: >10 NUMBERS CONTACT MFG)
  • Descripción del producto
    DRX-REVOLUTION MOBILE X-RAY SYSTEM
  • Manufacturer
    CARESTREAM HEALTH INC.

Manufacturer

CARESTREAM HEALTH INC.
  • Dirección del fabricante
    ROCHESTER
  • Empresa matriz del fabricante (2017)
    ONEX Corp
  • Source
    HC