[Recalled] 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
Authorities recorded a safety problem with this product. The details below come directly from the government recall notice.
Recall details
| 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 disp |
|---|---|
| Brand / manufacturer | Velocity Medical Solutions, LLC |
| Category | device |
| Issuing authority | FDA_DEVICE |
| Reference | Z-1275-2014 |
| Country of notice | United States |
| Risk level | Class II |
| Hazard type | recall |
| Notice date | 25 July 2013 |
Why it was recalled
According to the FDA_DEVICE notice, the identified hazard is: 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.
This Class II recall concerns device products distributed in United States and was recorded by FDA_DEVICE. Recalls in this category are published so that owners, retailers, and importers can identify affected units and act quickly.
What to do if you own this product
Check whether your unit is affected and follow the authority's guidance before further use.
Read the full official notice →
This page indexes a public government recall notice for reference. We do not sell or verify this product; always confirm the current status on the authority's official site.