Events

Retiro De Equipo (Recall) de Device Recall Micro Focus XRay generator

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 Hamamatsu Corporation.

¿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
    59760
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-3076-2011
  • Fecha de inicio del evento
    2011-07-07
  • Fecha de publicación del evento
    2011-09-13
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2018-01-29
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=103604
  • 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
    industrial x-ray - Product Code RBS
  • Causa
    It was discovered about a potential issue of x-ray leakage with our model # li1 0951-35 micro focus x-ray generator.
  • Acción
    Hamamatsu Corporation sent a letter dated July 19, 2011, to the manufacturer and their subcontractor informing them of the affected product and what they propose to do. They will repair the units both in the field and those returned to our plant by installing additional lead shielding in the units. The lead shielding will be fixed to the unit by soldering the addition to the existing lead shield (see attachment 2). We expect to complete the repair of all units in the field by October 1, 2011. All new units to be shipped from our plant will be repaired before shipment. For further questions, please call (908) 231-0960 X 2300

Device

Device Recall Micro Focus XRay generator
  • Modelo / Serial
    Model # L10951-35 Serial number SII00002 through SII00009.
  • Clase de dispositivo
    Not Classified
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution -- USA ( nationwide ) the countries of Aichi, India and Japan.
  • Descripción del producto
    Hamamatsu model L10951-35 Micro Focus x-ray generator. || The x-ray generator is incorporated into a cabinet x-ray system that is used for a variety of studies.
  • Manufacturer
    Hamamatsu Corporation

Manufacturer

Hamamatsu Corporation
  • Dirección del fabricante
    Hamamatsu Corporation, 360 Foothill Rd, Bridgewater NJ 08807
  • Empresa matriz del fabricante (2017)
    Hamamatsu Photonics K.K.
  • Source
    USFDA