Recall Z-1275-2014— Velocity Medical Solutions, LLC

Name: FDA recall Z-1275-2014
Creator: U.S. Food and Drug Administration
Published: 2013-07-25

Class II · Terminated

Class II FDA medical device recall by Velocity Medical Solutions, LLC, initiated 2013-07-25, terminated 2014-09-11. It names one FDA 510(k) clearance: K081076. 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..

Recalling firm: Velocity Medical Solutions, LLC
Classification: Class II
Status: Terminated
Initiated: 2013-07-25
Terminated: 2014-09-11
Firm location: Atlanta, GA, United States

510(k) clearances named in this recall

1 on FDA's record

K081076 — VELOCITYAIS, VELOCITY AI, VELOCITYVX, VELOCITYRT, V-RESPONSEVelocity Medical Solutions, LLC·cleared 2008-06-20

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Reason for recall

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.