Events

Retiro De Equipo (Recall) de Device Recall Ascom Mobile Monitoring Gateway

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 Ascom US, 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
    73578
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1638-2016
  • Fecha de inicio del evento
    2015-12-10
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2017-10-13
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=144525
  • 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,network and communication,physiological monitors - Product Code MSX
  • Causa
    Due to a malfunction of software, the secondary module will not automatically take over messaging if the primary module fails after a software upgrade to one of the other affected versions. messages from ge carescape/nurse call will not forward to handset until primary module is restored.
  • Acción
    On January 4, 2016 , the firm is initiating a field corrective action to update the software in the installed base and resynchronize the primary and secondary servers. All customers were sent a letter January 4, 2016, informing them of the voluntary recall of Ascom Mobile Monitoring Gateway and Unite Connect for Nurse Call. The reason stated for why the recall was initiated was that the secondary module would not take over the messaging function when the primary module failed, following a software upgrade. Ascom instructed customers to check if their software was one of the affected versions they should contact their local Ascom representative to review the MMG configuration and determine if the system is subject to malfunction. The same instructions were directed towards those who were not able to determine their software version. If it is determined that the program is subject to malfunction, the primary and secondary modules should be re-synchronized. A test of module redundancy should be conducted on re-synchronized modules. The second module should take over for the primary module within thirty seconds. Model redundancy should be tested frequently and following system upgrades. For more information call (919) 535-6143 , 8am till 4:30pm.

Device

Device Recall Ascom Mobile Monitoring Gateway
  • Modelo / Serial
    Ascom Mobile Monitoring Gateway version 4.1.1 & 4.2.0 and Ascom Unite Connect for Nurse Call version 2.2.0
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    CA, CT, FL, IA, ID, IL, IN, KY, LA, MA, MD, ME, MI, MO, NJ, NM, OH, OK, PA, TN, TX, VA, WA, WI and Hawaii. Australia, Austria, Belgium, Canada, France, Germany, Netherlands, Poland, Qatar, Sweden, Switzerland, and United Arab Emirates.
  • Descripción del producto
    Ascom Mobile Monitoring Gateway (versions 4.1.1 and 4.2.0) and Ascom Unite Connect for Nurse Call (version 2.2.0).
  • Manufacturer
    Ascom US, INC.

Manufacturer

Ascom US, INC.
  • Dirección del fabricante
    Ascom US, INC., 300 Perimeter Park Dr Ste D, Morrisville NC 27560-9703
  • Source
    USFDA