Events

Retiro De Equipo (Recall) de Merge Cardio

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
    76401
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1415-2017
  • Fecha de inicio del evento
    2016-04-04
  • Fecha de publicación del evento
    2017-03-08
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2017-03-20
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=153076
  • 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
    A situation can occur allowing two physicians to access the same study report in echoims when launched from the cardio study list without receiving the read-only notification prompt.
  • Acción
    Merge sent an Urgent: Medical Device Recall letter dated March 28, 2016, via e-mail on April 4, 2016. A letter was issued to nonresponders on July 11, 2016. The letter notifies the customer of the issue, informs them of the workaround, and that no further action was being taken to correct the issue, therefore, the customer needs to be aware of the possible behavior. The notification instructs the customer to pass the information onto all other users, as well as any downstream customers if it was further distributed. The notification also informs the customer their response is required using the enclosed form and the return addressed envelope. The response form asks, in part, if they understand the workaround. The response was required no later than April 18, 2016. Nonresponders were issued a second letter dated July 11, 2016, asking for a response by August 2, 2016. The letter and response form contained the same information as the first letter. If the second letter results in additional unresponsive customers, a call campaign will be managed by Customer Support and documented via SalesForce. Three call attempts will made before closing the case. For further information please call (877) 741-5369.

Device

Merge Cardio
  • Modelo / Serial
    Version 9.0.9 and earlier using EchoIMS.
  • Clasificación del producto
    Radiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    US Distribution was made to medical facilities in CA, FL, IL, MD, MO, OH, OK, TX, VT, and WI. Military distribution was also made.
  • Descripción del producto
    Merge Cardio software using EchoIMS. The firm name on the label is Merge Healthcare, Hartland, WI.
  • Manufacturer
    Merge Healthcare, Inc.

Manufacturer

Merge Healthcare, Inc.