Events

Retiro De Equipo (Recall) de ULTRA-SPEED DENTAL INTRAORAL FILM

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
    34797
  • Clase de Riesgo del Evento
    III
  • Fecha de inicio del evento
    2014-06-26
  • 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 incorrect orientation of the indicator dot on dental intraoral film packet labeling of some lots of insight item 811 0785 (size 0 packet) ib-01 and some lots of ultra-speed item 834 8658 (size 0 packet) df-48. the indicator dot on the film packet's outer printed paper labeling was incorrectly positioned relative to the location of the raised dot on the film. this issue may cause some confusion for the dental practitioner if the processed film is placed on the view box by referencing the film's raised dot. the result is the image orientation will be rotated 180 degrees. the remaining content on the label is correct. image quality is not affected by this issue.

Device

ULTRA-SPEED DENTAL INTRAORAL FILM
  • Modelo / Serial
    Model Catalog: 834 8658 (Lot serial: 333-012-01); Model Catalog: 834 8658 (Lot serial: 333-012-02); Model Catalog: 834 8658 (Lot serial: 333-012-03); Model Catalog: 834 8658 (Lot serial: 343-015-01); Model Catalog: 811 0785 (Lot serial: 538-013-03); Model Catalog: 811 0785 (Lot serial: 539-012-01); Model Catalog: 811 0785 (Lot serial: 545-012-01); Model Catalog: 811 0785 (Lot serial: 546-012-01)
  • Descripción del producto
    ULTRA-SPEED
  • Manufacturer
    CARESTREAM HEALTH CANADA COMPANY

Manufacturer

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