Events

Retiro De Equipo (Recall) de MYLA server HP Proliant

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 bioMerieux, 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
    71049
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1621-2015
  • Fecha de inicio del evento
    2015-04-14
  • Fecha de publicación del evento
    2015-05-15
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2017-12-13
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=135926
  • 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
    unknown device name - Product Code N/A
  • Causa
    The myla¿ server could slow down due to the volume (weight) of the data to manage and it could also stop processing, impacting the server start-up phase. the problem occurs in high volume settings. the myla server slows down and will stop processing completely if any task requires more than 5 minutes to complete. the server then fails to reboot and requires service, provided remotely or on-site.
  • Acción
    Consignees were notified electronically on April 14, 2015 and letter via FedEx on 04/20/2015.

Device

MYLA server HP Proliant
  • Modelo / Serial
    Ref. #415603 and 411402
  • Distribución
    Worldwide Distribution-Algeria, Argentina, Australia, Austria, Brazil Canada, Chile China, Colombia, Czech Republic, France Germany , Greece, Hungary, India, Italy Japan, Korea, Mexico, Netherlands, Poland, Portugal, Russia, Serbia, Singapore, South Africa, Spain, Sweden, Switzerland, Thailand, Turkey, Angola, Armenia, Kocaeli, Bahrain, Bangladesh, Republic of Belarus, Benin, Bolivia, Bosnia, Brunei, Bulgaria, Burkina Faso, Cambodia, Cameroon, Chad, Democratic Republic of Congo, Costa Rica, Germany Dominican Republic, Dutch Antilles, Ecuador, Egypt, El Salvador, Estonia, Ethiopia, Gabon, Georgia, Guam, Guatemala, Guinea, Honduras, Indonesia, Iran, Iraq, Israel, Ivory Coast, Kazakhstan, Kenya, Kuwait, Laos, Latvia, Lebanon, Libya, Lithuania, Macedonia, Malaysia, Mali, Malta, Morocco, Portugal, Myanmar, Managua, Niger, Nigeria, Oman, Palestine, Panama, Paraguay, Peru, Philippines, Qatar, Romania, Kingdom of Saudi Arabia, Senegal, Slovakia, Sri Lanka, Tanzania, Togo, Tunisia, Ukraine, UAE, Uraguay, Venezuela, Vietnam, Yemen and Zimbabwe.
  • Descripción del producto
    MYLA server HP Proliant: DL380-G8 and ML350-G6 version 3.xx computer application software. || MYLA V3 is a computer application ("Middleware") based on Web 2.0 technology which: Interfaces between the instruments connected to the application and the LIS(s) (Laboratory Information System(s).
  • Manufacturer
    bioMerieux, Inc.

Manufacturer

bioMerieux, Inc.
  • Dirección del fabricante
    bioMerieux, Inc., 100 Rodolphe St, Durham NC 27712-9402
  • Empresa matriz del fabricante (2017)
    Compagnie Merieux Alliance
  • Source
    USFDA