Events

Retiro De Equipo (Recall) de CS 8100 3D

Según Health Canada (via FOI), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Canada que fue producido por CARESTREAM HEALTH CANADA COMPANY.

¿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
    20255
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2015-01-23
  • 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 has identified an issue related to the manufacturing process of cs 8100 and cs 8100 3d tomographic digital panoramic x-ray systems manufactured between june 2012 and september 2014 which could result in the head unit descending unexpectedly and contacting the patient. the issue was found at an installation and nobody was injured. it has been determined that the root cause was a circlip (retaiing clip) on a pin used to mate the lower and upper portions of the stand not being fitted at the time of manufacture. this allowed the locating pin to move out of position within the location hole during transportation. there is no hazard during transport and the issue would now be found at any new installation. testing has shown that even without both circlips fitted the pin does not fall out during use but could move therefore to ensure all installed devices are not affected and will perform as designed through their expected life a field inspection recall is being initiated.

Device

CS 8100 3D
  • Modelo / Serial
    Model Catalog: 5311162 (Lot serial: CIID071); Model Catalog: 531 1329 (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: 530 3045 (Lot serial: >10 NUMBERS CONTACT MFG)
  • Descripción del producto
    CS 8100 3D
  • Manufacturer
    CARESTREAM HEALTH CANADA COMPANY

Manufacturer

CARESTREAM HEALTH CANADA COMPANY
  • Dirección del fabricante
    VAUGHAN
  • Empresa matriz del fabricante (2017)
    ONEX Corp
  • Source
    HC