Retiro De Equipo (Recall) de RadSuite iConnect

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
    76654
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1470-2017
  • Fecha de inicio del evento
    2016-04-04
  • Fecha de publicación del evento
    2017-03-10
  • Estado del evento
    Open, Classified
  • País del evento
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
  • 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
    Device, digital image storage, radiological - Product Code LMB
  • Causa
    The software produced a number of "do not route" exceptions, which may result in potential patient injury or delay in diagnosis or treatment.
  • Acción
    Merge Healthcare sent an Urgent: Medical Device Recall letter dated March 28, 2016, via e-mail the week of April 4, 2016. If no email address was available, the letters were issued via certified mail. A second letter dated July 11, 2016, was issued to nonresponders. The letter notifies the customer of the issue and informs them a fix has been released for the issue. 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 are interested in accepting the fix. If they decline the fix, they are asked to provide the reason why. 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. The recalling firm reported emails will be tracked for delivery confirmation and the letters will be tracked for delivery by USPS certified services. For further questions, please call (877) 741-5369.

Device

  • Modelo / Serial
    iConnect Enterprise Archive versions 5.30.0 thru 9.4.3 and V11.0.
  • Clasificación del producto
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    USA (nationwide ) Distribution to medical facilities. Government distribution was also made. There was no foreign or military distribution.
  • Descripción del producto
    iConnect Enterprise Archive when used with RadSuite. The firm name on the label is Merge Healthcare.
  • Manufacturer

Manufacturer