Events

Recall of Device Recall NovaPACS

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Novarad Corporation.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    74556
  • Event Risk Class
    Class 2
  • Event Number
    Z-2151-2016
  • Event Initiated Date
    2013-05-09
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-12-01
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=147900
  • Notes / Alerts
    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.
  • Extra notes in the data
    System, image processing, radiological - Product Code LLZ
  • Reason
    Potential for images to be flipped while streaming, which could incorrectly display image orientation markers.
  • Action
    Consignees were notified on 05/09/13 via letter and email to upgrade software and to turn off streaming function.

Device

Device Recall NovaPACS
  • Model / Serial
    All NovaPAC software versions 7.4, 7.5, 7.6, and 8.0
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide distribution including US nationwide. No Canadian distribution.
  • Product Description
    NovaPACS  versions 7.4, 7.5, 7.6, and 8.0, Diagnostic Viewer. Distributed by Novarad Corporation. Picture archiving and communication system (PACS)
  • Manufacturer
    Novarad Corporation

Manufacturer

Novarad Corporation
  • Manufacturer Address
    Novarad Corporation, 752 E 1180 S Ste 200, American Fork UT 84003-3561
  • Manufacturer Parent Company (2017)
    Novarad Corporation
  • Source
    USFDA