Recall Z-2871-2016 ยท LLZ System, Image Processing, Radiological
Merge Healthcare, Inc.
CADstream software. Product Usage: CADstream is an image processing system designed to assist in the visualization, analysis, and reporting of magnetic resonance imaging (MRI) studies. CADstream also is intended to provide workflow efficiency and interventional planning tools.
| Date | Nov 1, 2012 |
| Status | Terminated |
| Reason | An incorrect biopsy or missed target could result if the incorrect grid is selected within the application. |
| Root cause | Error in labeling |
| Action | Merge sent Urgent Medical Device Recall dated January 28, 2016 to affected customers. The letter identified the affected product, problem and actions to be taken. For questions Merge Customer Service at (877) 741-5369 or support@merge.com. |
| Quantity | 1,349 sites potentially have the affected versions |
| Distribution | US Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K092954 | CADSTREAM VERSION 5 Confirma, Inc., Nov 6, 2009 |