Reported Apr 2, 2014 · Terminated
DICOM Export Format for Sum Dose with Velocity v3.0.0. A stand-alone software product that provides the oncology care…
Velocity Medical Solutions, LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Velocity Medical Solutions, LLC · 75 5th St Nw · Atlanta, GA · 30308-1019
Is this the product you have?
- 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.
- Lot codes and dates
- VelocityAIS 3.0.0
- Amount recalled
- 54 installs
Where it was sold
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
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