Events

Retiro De Equipo (Recall) de Device Recall SCOPIX LR 5200P Laser Imagers

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 AGFA Corp..

¿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
    27844
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0207-04
  • Fecha de inicio del evento
    2003-11-25
  • Fecha de publicación del evento
    2003-12-11
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2004-10-01
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=30627
  • 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
    Camera, Multi Format, Radiological - Product Code LMC
  • Causa
    The gs1 circuit board may fail resulting in smoke or fire.
  • Acción
    Consignees were notified by letter on 11/25/2003. They were informed of the problem and were advised, if they have the affected type and serial number, to contact the Agfa service representative to arrange for repair. The firm intends to install a modified circuit board on each machine remaining in operation at customer locations. Consignees were instructed to discontinue use of the device immediately and to disconnect the unit from the power supply if any odor of smoke or fire is detected. They were urged to complete the Customer Acknowledgement form included with the letter and return it in the enclosed postage paid envelope.

Device

Device Recall SCOPIX LR 5200P Laser Imagers
  • Modelo / Serial
    Model number LR 5200P, Catalog number: EMQT S000, Types: 8394/600, Serial numbers: 4000 through 5266.
  • Clasificación del producto
    Radiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    The units were distributed to hospitals and other health facilities located nationwide
  • Descripción del producto
    SCOPIX ¿ LR 5200P¿ Laser Imagers, Type 8394/600, serial numbers between 4000 and 5266.
  • Manufacturer
    AGFA Corp.

Manufacturer

AGFA Corp.
  • Dirección del fabricante
    AGFA Corp., 10 S Academy St, Greenville SC 29601-2632
  • Source
    USFDA