Events

Recall of Device Recall DICOM

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

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
    67615
  • Event Risk Class
    Class 2
  • Event Number
    Z-1275-2014
  • Event Initiated Date
    2013-07-25
  • Event Date Posted
    2014-03-25
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-09-11
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=125842
  • 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
    An anomaly was detected such that, under certain conditions, a summed dose created by velocity replaces the calculated dose from an approved plan in eclipse when importing the dose from velocity.
  • Action
    Velocity Medical Solutions sent a Urgent Field Safety Notice dated July 25th, 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Velocity advises customers creating Dose volumes in Velocity to refrain from exporting these dose files to Eclipse until the customers install has been upgraded to Velocity 3.0.1, which will be available August 5th, 2013. A new version of Velocity that corrects this error, Velocity v3.0.1, will be available on August 5th, 2013 for upgrade at no cost. Please contact your Velocity Medical representative to obtain this upgrade. Service representative will upgrade the application at your earliest convenience. Please advise the appropriate personnel working in your medical department of the content of this letter. We sincerely apologize for any inconvenience and thank you in advance for your co-operation. Contact Information. Helpdesk: (404) 920-1966 or (855) 857-0802 and press 2.

Device

Device Recall DICOM
  • Model / Serial
    VelocityAIS 3.0.0
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US (nationwide) including the states of AL, CA, CO, CT, DC, FL, GA, IL, IN, LA, MA, MD, MI, MS, NC, NY, PA, SC, TN, TX, WI, and the countries of Belarus, Italy and Switzerland.
  • Product Description
    DICOM Export Format for Sum Dose with Velocity v3.0.0. || A stand-alone software product that provides the oncology care specialists (physicians, physicists, dosimetrists, etc.) a means for comparison of medical imaging data from multiple DICOM conformant imaging modality sources. It allows the display, annotating, volume rendering, registration and fusing of medical images as an aid during use by diagnostic radiology, oncology, radiation therapy planning and other medical specialties.
  • Manufacturer
    Velocity Medical Solutions, LLC

Manufacturer

Velocity Medical Solutions, LLC
  • Manufacturer Address
    Velocity Medical Solutions, LLC, 75 5th St Nw, Atlanta GA 30308-1019
  • Manufacturer Parent Company (2017)
    Varian Medical Systems Inc
  • Source
    USFDA