Events

Retiro De Equipo (Recall) de Device Recall American Science & Engineering Inc, Gemini Cabinet Xray system

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 American Science & Engineering, 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
    71696
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2206-2015
  • Fecha de inicio del evento
    2015-05-22
  • Fecha de publicación del evento
    2015-08-14
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2017-02-22
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=138765
  • 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
    Cabinet x-ray, security (includes baggage x-ray) - Product Code RCG
  • Causa
    During factory testing, we discovered that gemini systems could, in rare circumstances, experience a fault that leads to a state in which x-rays are being produced but the x-ray indicator lights (located on the operator's console and on both ends of the tunnel) are not illuminated.
  • Acción
    American Science Engineering, Inc (AS&E;) is developing a fix for this problem that includes updating a software configuration on the X-ray source. You will be notified by field service as soon as this update is available. Please inform all operators of the system about this communication, so they are aware of the need to shut down and re-start the system should this fault occur. We appreciate your understanding. if you have any questions, please feel free to contact AS&E; via e-mail at service@as-e.com. If you are under a service contract, you can also contact your customer service representative. For further questions please call (978) 262-8700.

Device

Device Recall American Science & Engineering Inc, Gemini Cabinet Xray system
  • Modelo / Serial
    Gemini systems
  • Clase de dispositivo
    Not Classified
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - US Distribution to the states of : NY, FL, TN, PA, NJ, DE, ME, TX, CT, MS, NC, MD, MO, VA, DC, NV and GA., and to the countries of : Saudi Arabia, Indonesia, Canada, Netherlands, Hong Kong, Lebanon and Kazakhstan.
  • Descripción del producto
    American Science & Engineering Inc,Gemini Cabinet X-ray system.
  • Manufacturer
    American Science & Engineering, Inc.

Manufacturer

American Science & Engineering, Inc.
  • Dirección del fabricante
    American Science & Engineering, Inc., 829 Middlesex Tpke, Billerica MA 01821-3907
  • Empresa matriz del fabricante (2017)
    OSI Systems Inc
  • Source
    USFDA