Z-1275-2014Class II

DICOM Export Format for Sum Dose with Velocity v3.0.0. A stand-alone software product that provides the...

Name: Z-1275-2014 DICOM Export Format for Sum Dose with Velocity v3.0.0. A stand-alone software product that provides the...
Creator: Velocity Medical Solutions, LLC
Published: 2013-07-25
License: https://open.fda.gov/license/

Varian Medical Systems, Inc. / initiated 2013-07-25 / Terminated / root cause: software

FDA source

Velocity Medical Solutions, LLC began a recall of DICOM Export Format for Sum Dose with Velocity v3.0.0. A stand-alone software product that provides the oncology care specialists (physicians, physicists... on 2013-07-25. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-1275-2014
Classification: Class II
Status: Terminated
Initiated: 2013-07-25
Posted: 2014-03-25
Terminated: 2014-09-11
Recalling firm: Varian Medical Systems, Inc.
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.
Product code: LLZ System, Image Processing, Radiological
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.
Root cause tag: software
FDA 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 in commerce: 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.
Product codes and lots: VelocityAIS 3.0.0

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1275-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1275-2014	Class II	Terminated	Voluntary: Firm initiated	2014-04-02	2014-03-25

Product code LLZ

K081076Class IIVelocityais, Velocity Ai, Velocityvx, Velocityrt, V-ResponseVelocity Medical Solutions, LLC / cleared 2008-06-20

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)