CLASS II Device recall · Reported 2 Apr 2014 · FDA Enforcement Report
Dicom Export Format for Sum Dose with Velocity v3.0.0 recalled
Velocity Medical Solutions is recalling Dicom Export Format for Sum Dose with Velocity v3.0.0, distributed nationwide in the US. The recall was initiated on 25 Jul 2013 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1275-2014
- FDA event ID
- 67615
- Recalling firm
- Velocity Medical Solutions, Atlanta, GA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 25 Jul 2013
- FDA classified
- 25 Mar 2014
- Reported
- 2 Apr 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Imaging Equipment
Timeline
| 25 Jul 2013 | Recall initiated by company | |
| 25 Mar 2014 | Classified by FDA | +243 days |
| 2 Apr 2014 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
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.
Where it was distributed
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.
Nationwide AlabamaCaliforniaColoradoConnecticutDistrict of ColumbiaFloridaGeorgiaIllinoisIndianaLouisianaMassachusettsMarylandMichiganMississippiNorth CarolinaNew YorkPennsylvaniaSouth CarolinaTennesseeTexas
Questions about this recall
Is Dicom Export Format for Sum Dose with Velocity v3.0.0 recalled?
Yes. Velocity Medical Solutions recalled Dicom Export Format for Sum Dose with Velocity v3.0.0 on 25 Jul 2013. The recall is Class II and its status is Terminated. Recall number Z-1275-2014.
Why was it 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.
Which lots are affected?
VelocityAIS 3.0.0
Where was it sold?
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.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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