Events

Retiro De Equipo (Recall) de NovaPACS

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 Novarad Corporation.

¿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
    74937
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2659-2016
  • Fecha de inicio del evento
    2016-08-12
  • Fecha de publicación del evento
    2016-08-25
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2017-02-22
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=148855
  • 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
    Novarad corporation announces a voluntary field action for the novapacs versions 8.4.7, 8.5.3, and 8.5.6 due to a "pop-up screen" that was prematurely released.
  • Acción
    Novarad sent an Urgent Medical Device Correction letter dated August 12, 2016, to all affected consignees. As a workaround, customers are advised to use the HTMLS Viewer for review purposes only and not for diagnostic purposes. The issue has been fixed in all future releases of NovaPACS software. You can eliminate the possibility of incorrect information appearing by contacting Novarad Technical Supoort to arrange for an upgrade to a corrected version of NovaPACS software. This correction is available to all affected customers at no cost and will be included din all future upgrades. Customers will need to fax, mail, or email th eincluded Acknowledgement and Receipt Form back to Novarad. Customers with questions or concerens regarding this notification or would like to request an upgrade, should contact Novarad Technical Support at 801-221-5895. For questions regarding this recall call 801-642-1001.

Device

NovaPACS
  • Modelo / Serial
    Versions 8.4.7, 8.5.3, and 8.5.6
  • Clasificación del producto
    Radiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - US (Nationwide) Canada and other foreign consignees.
  • Descripción del producto
    NovaPACS versions 8.4.7, 8.5.3, and 8.5.6. Distributed by Novarad Corporation. Picture archiving and communication system (PACS) || Product Usage NovaPACS is a picture archiving and communication system software that retrieves, archives, distributes, and displays images and data from all common modalities. NovaPACS uses a variety of workstations, including a Technologist Workstation, Enterprise Radiologist Workstation, Cardio Viewer and Workstation, NovaMG Workstation, and NovaWeb Web Viewer. The NovaPACS software makes images and data available in digital format from all common modalities. The images are viewed on a computer monitor or portable device. NovaPACS tools/features include the following: window, level, zoom, pan, digital subtraction, ejection fraction, cross localization, note-taking ability, voice dictation, and other similar tools. It includes the capability to measure distance and image intensity values, such as standardized uptake value. NovaPACS displays measurement lines, annotations, regions of interest, and fusion blending control functionality. Advanced features include 3D image rendering, virtual colonoscopy, and vessel analysis. Images and data are stored on a digital archive with multiple redundancies; images and data are available on-site and offsite. Novarad provides all software, including third party software (i.e. Windows¿ OS). NovaPACS software resides on third party hardware, which may vary depending on the client s PACS needs. All hardware is connected to the radiology department local area network. NovaPACS integrates with NovaRIS and may integrate with any other third party RIS software that has HL7 interface capabilities. NovaPACS is intended for the viewing, archiving, analysis, annotation, registration, distribution, editing, fusion, and processing of digital medical images and data acquired from diagnostic imaging devices and all DICOM devices, etc. NovaPACS is intended for use by trained healthcare professionals, including radiologists, physicians, technologists, clinicians, and nurses. NovaPACS allows the end user to display, manipulate, archive, and evaluate images. NovaPACS is not intended for diagnostic image review on a mobile platform. While NovaPACS provides tools to assist the healthcare professional determine diagnostic viability, it is the user's responsibility to ensure quality, display contrast, ambient light conditions, and to confirm image compression ratios are consistent with the generally accepted standards of the clinical application
  • Manufacturer
    Novarad Corporation

Manufacturer

Novarad Corporation
  • Dirección del fabricante
    Novarad Corporation, 752 E 1180 S Ste 200, American Fork UT 84003-3561
  • Empresa matriz del fabricante (2017)
    Novarad Corporation
  • Source
    USFDA