FDAClass IIApril 2, 2014

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

DICOM Export Format for Sum Dose with Velocity v3.0.0. A stand-alone software product that provides the oncology care specialists (physicians…

Why was DICOM Export Format for Sum Dose with Velocity v3.0.0. recalled?

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.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

VelocityAIS 3.0.0

Product
DICOM Export Format for Sum Dose with Velocity v3.0.0. A stand-alone software product that provides the oncology care specialists (physicians…
Recalling firm
Velocity Medical Solutions, LLC
Quantity
54 installs
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.
Recall date
April 2, 2014
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls