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U.S. Department of Health and Human Services

Class 2 Device Recall DICOM

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 Class 2 Recall
DICOM
see related information
Date Posted March 25, 2014
Recall Status1 Open
Recall Number Z-1275-2014
Recall Event ID 67615
Premarket Notification
510(K) Number
K081076 
Product Classification System, Image Processing, Radiological - Product Code LLZ
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.
Code Information VelocityAIS 3.0.0
Recalling Firm/
Manufacturer
Velocity Medical Solutions, LLC
75 5th St Nw
Atlanta, Georgia 30308-1019
For Additional Information Contact Paul A. Pantalone
404-793-0372
Manufacturer 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.
FDA Determined
Cause 2
DESIGN: Software Design
Action 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.
Quantity in Commerce 54 installs
Distribution Worldwide Distribution - US 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. *** Center Recommended Depth is Consumer/User
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = LLZ and Original Applicant = VELOCITY MEDICAL SOLUTIONS, LLC
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