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

FDA device recall Z-1275-2014 · posted 2014-03-25 · Terminated

Recall details

Recalling firm

Velocity Medical Solutions, LLC

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.

Action taken

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.

Root cause

Software design

Status

Terminated

Product code

LLZ

Quantity affected

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

Date initiated

2013-07-25

Date posted

2014-03-25

Date terminated

2014-09-11

Location

Atlanta, GA

Related 510(k) clearances