Events

Retiro De Equipo (Recall) de Hologic QDR 4500

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 Hologic, 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
    51692
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1727-2009
  • Fecha de inicio del evento
    2009-04-07
  • Fecha de publicación del evento
    2009-08-25
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2010-11-29
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=80998
  • 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
    Bone Densitometer - Product Code KGI
  • Causa
    System may not turn off at the end of the x-ray and cause additional x-ray exposure.
  • Acción
    Hologic issued an Urgent: Medical Device Recall customer notification letter, dated April 17, 2009, by certified mail to inform customers of the problem. With the notification letter, customers will receive the following: -Software version Apex 12.6.2, 2.3.2, or 2.4.2 -Instructions to upgrade their systems with the provided software and to verify the new version on the system as a confirmation that the software was successfully loaded. -New Operator's Manual for installations where the operating characteristics of the system have changed due to the software upgrade. For Customers with systems with software versions other than 12.6, 2.3, or 2.4: Customers were asked to upgrade their QDR software, return their old QDR software disk, and complete and return to Hologic the enclosed Confirmation of Notification.

Device

Hologic QDR 4500
  • Modelo / Serial
    S/N: 45264A 45260A 45214A 45241A 45036A 47585C 49124C/CE 47513C 47758C 48342C/NCE 48337C/NCE 49781C/CE 48137C/NCE 47262C 45425SL/CE 45251SL 45751SL/CE 45815SL/CE, and  49521W/CE.
  • Clasificación del producto
    Radiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution -- USA, Canada, Europe, Austria, Belgium, Bulgaria, Czech Republic, Denmark, France, Germany, Great Britain, Greece, Hungary, Iceland, Italy, Latvia, Lithuania, Macedonia, Netherlands, Norway, Poland, Portugal, Romania, Russia, Serbia, Slovak Republic, Slovenia, Spain, Sweden, Switzerland, Turkey, Ukraine, Uzbekistan, Algeria, Arab Emirates, Argentina, Australia, Bahrain, Chile, China, Colombia, Costa Rica, Dominican Republic, Ecuador, Egypt, Hong Kong, Indonesia, India, Iran, Iraq, Israel, Japan, Jordan, Kenya, Korea, Kuwait, Lebanon, Malaysia, Morocco, Mexico, Pakistan, Peru, Puerto Rico, South Africa, Saudia Arabia, Singapore, Syria, Taiwan, Thailand, Tunisia, Venezuela, and Vietnam.
  • Descripción del producto
    Hologic QDR 4500 series Bone Densitometer || Software versions 12.6, 2.3., or 2.4 || Indicated for the estimation of bone mineral density (BMD), comparison of measurable variables obtained from a given QDR scan to a database of reference values, the estimation of fracture risk, vertebral deformity assessment, body composition analysis, and discrimination of bone from prosthetics.
  • Manufacturer
    Hologic, Inc.

Manufacturer

Hologic, Inc.
  • Dirección del fabricante
    Hologic, Inc., 35 Crosby Dr, Bedford MA 01730
  • Empresa matriz del fabricante (2017)
    Hologic Inc
  • Source
    USFDA