Events

Retiro De Equipo (Recall) de Merge Cardio software

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 Merge Healthcare, 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
    77124
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2123-2017
  • Fecha de inicio del evento
    2016-04-13
  • Fecha de publicación del evento
    2017-05-22
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2017-07-17
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=154998
  • 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, image processing, radiological - Product Code LLZ
  • Causa
    Fetal patient report was automatically pulling prior measurement data for a prior fetus since the fetal study is based on the mother's mrn, resulting in the wrong fetal measurements getting referenced.
  • Acción
    The recalling firm issued a "Medical Device Correction" letter dated 4/13/2016 via e-mail. The letter identified the affected product, issue involved, potential harm, a work around, as well as the actions to be performed by both the customer and firm. Merge Technical Support will contact customers to discuss the fix. Customers are to ensure that all users are provided the notice. If the affected product was further distributed, those customers should be identified and notified of the issue. A copy of the notice may be provided to those customers. If there are additional questions, customers can e-mail recall@merge.com.

Device

Merge Cardio software
  • Modelo / Serial
    Versions 10.0, 10.0.1, 10.1, 10.1.1,10.1.1.1, and 10.1.2.
  • Clasificación del producto
    Radiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Distributed to the states of AZ, CT, FL, GA, IL, IN, LA, MI, NY, NC, OH, OK, TX, and VT.
  • Descripción del producto
    Merge Cardio software. The firm name on the label is Merge Healthcare, Hartland, WI. || Intended to be used to acquire, store, print, transfer, and archive clinical information.
  • Manufacturer
    Merge Healthcare, Inc.

Manufacturer

Merge Healthcare, Inc.