Z-1275-2014 Class II Terminated
FDA device recall Z-1275-2014 was initiated by Velocity Medical Solutions, LLC on July 25, 2013 and is designated Class II. 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. The recall status is terminated (terminated September 11, 2014). Affected quantity: 54 installs.
Recall Details
- Product Type
- Devices
- Report Date
- April 2, 2014
- Initiation Date
- July 25, 2013
- Termination Date
- September 11, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 54 installs
Product Description
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.
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.
Distribution Pattern
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.
Code Information
VelocityAIS 3.0.0