DICOM Export Format for Sum Dose with Velocity v3.0.0…

Date

April 2, 2014

Risk class

Class II (FDA's definition, 21 CFR 7.3(m): a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote)

Status

Terminated

Filed by

Velocity Medical Solutions, LLC

Product

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.

Distribution pattern

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

Codes and lots

VelocityAIS 3.0.0

Recall started

July 25, 2013

Device type

System, Image Processing, Radiological

Root cause (FDA)

Software design

What the company told customers

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.

Recall number

Z-1275-2014

What should I do? How serious is a recall? Classes and warnings explained

Source: FDA · Medical device enforcement report, recall number Z-1275-2014. The agency record governs; check it and the company before acting.