The Recall Desk
SevereFDA (Devices)·Z-1275-2014·Announced 2014-04-02

Velocity Medical Solutions Recalls DICOM Export Format Software

Velocity Medical Solutions is recalling DICOM Export Format for Sum Dose v3.0.0 software because it may replace calculated doses in Eclipse treatment plans.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class II. Per the rubric, FDA Class II recalls are assigned a severity score of 4 (Severe), particularly given the potential for significant injury due to incorrect radiation dose application in oncology treatment.

Plain-English summary

Velocity Medical Solutions, LLC is recalling DICOM Export Format for Sum Dose with Velocity v3.0.0. This stand-alone software product is used by oncology care specialists to compare medical imaging data from multiple DICOM conformant imaging modality sources. It allows for the display, annotating, volume rendering, registration, and fusing of medical images to aid in diagnostic radiology, oncology, and radiation therapy planning.

The recall was initiated because an anomaly was detected where, 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. This issue affects 54 installs of the software.

The product was distributed worldwide, including nationwide in the United States (specifically in AL, CA, CO, CT, DC, FL, GA, IL, IN, LA, MA, MD, MI, MS, NC, NY, PA, SC, TN, TX, and WI) and in the countries of Belarus, Italy, and Switzerland. Users of the software should contact Velocity Medical Solutions, LLC for further instructions regarding the recall.

The recalled product

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
Manufacturer
Velocity Medical Solutions, LLC
Category
Medical Device — Software
Hazard
Affected units
54

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • VelocityAIS 3.0.0

Distribution

Distributed nationwide across the United States.

The notice also names 21 states specifically:

Related recalls

Same hazard · incorrect dose

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