Events

Retiro De Equipo (Recall) de Millennium Nuclear Medicine Systems

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 GE Healthcare.

¿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
    33062
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0413-06
  • Fecha de inicio del evento
    2005-04-18
  • Fecha de publicación del evento
    2006-01-24
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2008-02-24
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=41268
  • 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, Tomography, Computed, Emission - Product Code KPS
  • Causa
    In certain cases, one of the four collimator locking mechanisms that attach the collimator to the head may work itself free if collimator exchange has not been performed for an extended period of time. this situation, if neglected, could eventually cause the locking mechanism to unlock itself.
  • Acción
    Customer letter is being sent to all customers who have an affected system. The letter alerts customers of the potential release of the locking mechanism and requires a Weekly Collimator Exchange Procedure to avoid release of the locking latch until the permanent solution is made available.

Device

Millennium Nuclear Medicine Systems
  • Modelo / Serial
    all serial numbers
  • Clasificación del producto
    Radiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    nationwide including Puerto Rico, and to countries including: Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, Denmark, Egypt, France, Germany, Iceland, India, Israel, Italy, Jordan, Korea, Kuwait, Luxembourg, Martinique, Mexico, New Zealand, Philippines Romania, Saudi Arabia, Slovenia, South Africa, Spain, Sweden, Taiwan and United Kingdom.
  • Descripción del producto
    GE Millennium Systems: MPR and MPS Digital CSE Single Detector Gamma Camera. This system is a multi-purpose single-head nuclear medicine imaging system, comprised of a Digital CSE (Correlated Signal Enhancement) multi-purpose square detector, a pass-through counter-balanced ring gantry, a SPECT-optimized imaging table, and a collimator cart.
  • Manufacturer
    GE Healthcare

Manufacturer

GE Healthcare
  • Dirección del fabricante
    GE Healthcare, 3000 N Grandview Blvd, Waukesha WI 53188-1615
  • Empresa matriz del fabricante (2017)
    General Electric Company
  • Source
    USFDA