Company Velocity Medical Solutions, LLC.
Date of Enforcement Report:4/2/2014
Class lI:
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.
Recall Number Z-1275-20144
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/MANUFACTURER
Velocity Medical Solutions, LLC, Atlanta, GA on 7/25/2103. Voluntary recall has been completed
VOLUME OF PRODUCT IN COMMERCE
54 installs
DISTRIBUTION
Nationwide and Internationally
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