FDA Enforcement Class II Terminated

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.

Recall: Z-1275-2014 · Reported April 2, 2014

Enforcement

Recall Number
Z-1275-2014
Event ID
67615
Classification
Class II
Status
Terminated
Product Type
Devices
Firm
Velocity Medical Solutions, LLC
Voluntary / Mandated
Voluntary: Firm initiated
Initial Notification
Letter
Report Date
April 2, 2014
Initiation Date
July 25, 2013
Classification Date
March 25, 2014
Termination Date
September 11, 2014
Address
75 5th St Nw, N/A, Atlanta, GA, 30308-1019, United States

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.

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.

Code Info

VelocityAIS 3.0.0

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.

Quantity

54 installs