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Velocity Medical Solutions, LLC recalls DICOM Export Format for Sum Dose with Velocity v3.0.0. A stand-alone software product that provides the oncology care
Recalled April 2, 2014 · FDA recall Z-1275-2014 · Velocity Medical Solutions
Hazard
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 Class II
Units
54 installs
Sold at
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.
Description
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.
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.
Manufacturer(s)
Velocity Medical Solutions, LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →