Events

Retiro De Equipo (Recall) de DR Systems Unity PACS software, now known as Merge Unity PACS

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
    76541
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1426-2017
  • Fecha de inicio del evento
    2016-04-08
  • Fecha de publicación del evento
    2017-03-09
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2017-03-17
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=153466
  • 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
    Reports were missing demographic header information when they were faxed to referring physicians.
  • Acción
    Merge sent an Urgent : Medical Device Recall letter dated March 28, 2016, to all affected customers via email on April 8, 2016. Nonresponders were issued a second letter dated July 11, 2016. The letter notifies the customer of the issue, makes them aware of a workaround, and informs them a fix is available. 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 8, 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. For further questions please call ( 877) 741-5369.

Device

DR Systems Unity PACS software, now known as Merge Unity PACS
  • Modelo / Serial
    Version 11.0
  • Clasificación del producto
    Radiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    US Distribution was made to medical facilities in CA, MT, PA, and TX. There was no foreign/military/government distribution.
  • Descripción del producto
    DR Systems Unity PACS software, now known as Merge Unity PACS
  • Manufacturer
    Merge Healthcare, Inc.

Manufacturer

Merge Healthcare, Inc.