Events

Retiro De Equipo (Recall) de Device Recall Merge Unity Z3D 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
    74846
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2551-2016
  • Fecha de inicio del evento
    2015-07-23
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2016-10-07
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=148592
  • 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
    The software is unable to accurately determine the calcium score of scans with a slice thickness not equal to 3 mm.
  • Acción
    The firm, Merge, sent a "canned" email on 7/23/2015 to its customers which also contained a personal message. The recalling firm issued a second letter entitled "URGENT: MEDICAL DEVICE RECALL" dated 1/27/2016 via e-mail on 1/30/2016. The letters described the product, problem and actions to be taken. The letter informed customers that an upgrade is available. The customers were instructed to call Merge Customer Service at (877) 741-5369 or send an email to support@merge.com to schedule the upgrade-Reference this recall #2016-14. If you decide to decline this maintenance release, complete the attached form and return to Merge Healthcare via recall@merge.com. Alternatively, complete the online form: http://www.merge.com/Landing-Pages/Customer-Upgrade-Decline-Form.aspx no later than February 22, 2016. Ensure that all users of the product are provided with this notification. If you have further distributed this, identify your customers and notify them at once of this product recall and provide a copy of the recall notification letter. If you have any additional questions, call Merge Customer Service at (877) 741-5369 or support@merge.com.

Device

Device Recall Merge Unity Z3D software
  • Modelo / Serial
    Version 11.0
  • Clasificación del producto
    Radiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    US Distribution to states of: CA, PA, TX, and MT.
  • Descripción del producto
    Merge Unity Z3D software. || Merge Unity PACS (formerly DR Systems PACS) is a medical image and information management system that allows viewing, selection, processing, printing, telecommunications, and media interchange of medical images from a variety of diagnostic imaging systems.
  • Manufacturer
    Merge Healthcare, Inc.

Manufacturer

Merge Healthcare, Inc.