02

Apr

2014

Velocity DICOM Export Format for Sum Dose Cl II

0

Company Velocity Medical Solutions, LLC.
Date of Enforcement Report:4/2/2014
Class lI:

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.
Recall Number Z-1275-20144

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.

RECALLING FIRM/MANUFACTURER
Velocity Medical Solutions, LLC, Atlanta, GA on 7/25/2103. Voluntary recall has been completed

VOLUME OF PRODUCT IN COMMERCE
54 installs

DISTRIBUTION
Nationwide and Internationally

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About the author

Amy Sellers

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

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