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
    73977
  • Event Risk Class
    Class 2
  • Event Number
    Z-1613-2016
  • Event Initiated Date
    2015-11-16
  • Event Date Posted
    2016-05-06
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-08-17
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=145814
  • 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
    The suv values that are being calculated in the pet/ct fusion tool are incorrect.
  • Action
    Consignees were notified on 11/16/15 via letter to contact Novarad Technical Support to arrange for an upgrade to a corrected version of NovaPACS software.

Device

Device Recall NovaPACS
  • Model / Serial
    Versions 8.3.7, 8.4.2, 8.4.3, and 8.4.4
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide. 3 Canadian and 33 foreign consignees. No VA/gov/military.
  • Product Description
    NovaPACS  Diagnostic Viewer versions 8.3.7, 8.4.2, 8.4.3, and 8.4.4. Novarad Corporation
  • 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