FDA Medical Device Recalls (openFDA)
Velocity Medical Solutions, LLC: 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-1275-2014
- Recalling firm
- Velocity Medical Solutions, LLC
- 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.
- Status
- Terminated
- Initiated
- 2013-07-25
- Posted
- 2014-03-25
- Terminated
- 2014-09-11
- 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.
- Root cause
- Software design
- Action
- Velocity Medical Solutions sent a Urgent Field Safety Notice dated July 25th, 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Velocity advises customers creating Dose volumes in Velocity to refrain from exporting these dose files to Eclipse until the customers install has been upgraded to Velocity 3.0.1, which will be available August 5th, 2013. A new version of Velocity that corrects this error, Velocity v3.0.1, will be available on August 5th, 2013 for upgrade at no cost. Please contact your Velocity Medical representative to obtain this upgrade. Service representative will upgrade the application at your earliest convenience. Please advise the appropriate personnel working in your medical department of the content of this letter. We sincerely apologize for any inconvenience and thank you in advance for your co-operation. Contact Information. Helpdesk: (404) 920-1966 or (855) 857-0802 and press 2.
- Quantity
- 54 installs
- Distribution
- 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.
- Lot, serial or model codes
- VelocityAIS 3.0.0
- 510(k) numbers
- ["K081076"]
- PMA numbers
- not on file
- Product code
- LLZ
- Firm FEI
- 3007157255
- Firm city
- Atlanta
- Firm state
- GA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28