Events

Recall of Device Recall EVMS (Enterprise Visual Medical System Software)

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

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
    47526
  • Event Risk Class
    Class 3
  • Event Number
    Z-1644-2008
  • Event Initiated Date
    2008-01-01
  • Event Date Posted
    2008-05-28
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2009-06-11
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=69669
  • 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
    Picture archiving and communications system - Product Code LLZ
  • Reason
    Miscalculation: the calculation of the standard uptake value does not include the required calibration factor/decay correction factor. the resulting value is incorrectly calculated, which may lead to incorrect interpretation of tissue density. the calculation error exists in both the software and user guide.
  • Action
    Consignees were notified by Urgent Device Correction letters that were sent on 1/9/08 and 1/18/08. The letters instructed users not to use the standard uptake value in EVMS for diagnostic interpretation when viewing PET studies unless they received service bulletin 445, 446 or 7.0.1. Users were also instructed to replace pages in the user's guide with the pages provided and to affix the enclosed warning sticker on all workstations. Users will be contacted by the recalling firm to schedule a software patch.

Device

Device Recall EVMS (Enterprise Visual Medical System Software)
  • Model / Serial
    Model Numbers: 5.30.4, 5.30.5, 5.30.6, 5.30.7, 5.40.0 and 7.0.0.1.
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution including states of: MI, WI, CA, MN, AZ, CO, MN, MD, DC, MO, TX, IL, GA, FL, WI, SC, PA, NY, KS, TN, AL and OK.
  • Product Description
    EVMS (Enterprise Visual Medical System); Picture archiving and communications system; Model Numbers: 5.30.4, 5.30.5, 5.30.6, 5.30.7, 5.40.0 and 7.0.0.1. Emageon, Inc., Hartland, WI 53029.
  • Manufacturer
    Emageon

Manufacturer

Emageon
  • Manufacturer Address
    Emageon, 900 Walnut Ridge Dr, P.O. Box 950, Hartland WI 53029-0950
  • Source
    USFDA