Events

Retiro De Equipo (Recall) de Device Recall REGIUS IM, RIM

Según U.S. Food and Drug Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en United States que fue producido por Konica Minolta Medical Imaging USA, 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
    34785
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0862-06
  • Fecha de inicio del evento
    2006-02-06
  • Fecha de publicación del evento
    2006-05-16
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2008-08-22
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=44641
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    System, Image Processing, Radiological - Product Code LLZ
  • Causa
    If the patient demographic data is entered into the cs-1 manually, and the user fails to enter any data in one of the demographic data fields labeled as birthday, sex, name or patient comments, etc, the rim will populate the fields where no data has been entered with data from the previous patient.
  • Acción
    The firm phoned the customers on 2/6/2006 to inform them of the recall and the corrective action associated to the recall. This will be followed up with a fax, e-mail and letter. The final step will be visiting the location to install the correct software.

Device

Device Recall REGIUS IM, RIM
  • Modelo / Serial
    58 units distributed between June 2003 and January 2006. Software version prior to January 31, 2006.
  • Clasificación del producto
    Radiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    The units were distributed to hospitals nationwide through the firm''s sales force and resellers. There are no government accounts.
  • Descripción del producto
    REGIUS Image Manager (AKA REGIUS IM, RIM). Catalogue Number 5900554. Centralized CR Image Quality Control. Patient throughput optimization via offloaded processing from various CR readers. Technologist review and audit. Key processing for specialized exams, totally automated processing for hands off operation. Centralized workflow device for dispersed readers environments. HIS/RIS patient status updates. Demographic Correction.
  • Manufacturer
    Konica Minolta Medical Imaging USA, Inc.

Manufacturer

Konica Minolta Medical Imaging USA, Inc.
  • Dirección del fabricante
    Konica Minolta Medical Imaging USA, Inc., 411 Newark Pompton Tpke, Wayne NJ 07470-6657
  • Source
    USFDA