Events

Retiro De Equipo (Recall) de Device Recall Merge OfficePACS

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
    74522
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2144-2016
  • Fecha de inicio del evento
    2016-01-30
  • Fecha de publicación del evento
    2016-07-08
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2017-02-03
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=147824
  • 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
    Potential data loss occurs as a result of the software archiving not working properly.
  • Acción
    Merge Healthcare sent an Urgent Medical Device Recall letter dated January 26, 2016, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customers. Customers were instructed to provide a copy of the notification to all users. For additional questions customers were advised to call Merge Customer Service at (87) 741-5369. For questions regarding this recall call 262-367-0700.

Device

Device Recall Merge OfficePACS
  • Modelo / Serial
    Software versions: 4.0, 4.1, 4.1.1, 4.1.2, and 4.2
  • Clasificación del producto
    Radiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    The software was distributed nationwide to medical facilities. There was no government/military/foreign distribution.
  • Descripción del producto
    Merge OfficePACS software. The firm name on the label is Merge Healthcare, Hartland, WI. || OfficePACS is intended for the manipulation and displaying of medical images by a suitable licensed and qualified healthcare professional. It can show images from different modalities and interfaces to various image storage and printing devices using DICOM or similar interface standards. OrthoPACS also uses such images, in conjunction with templates for prosthetic devices, for the purposes of choosing the nature and characteristics of the prosthetic device to be used when planning a potential surgical procedure.
  • Manufacturer
    Merge Healthcare, Inc.

Manufacturer

Merge Healthcare, Inc.