Recall Z-0118-2017 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 | Oct 19, 2011 |
| Status | Terminated |
| Reason | Customers may experience an issue with the software study preferences when changes are made to the study protocol, resulting in incorrect patient follow-up. |
| Root cause | Software design |
| Action | Merge sent an Urgent Medical Device Recall dated January 28, 2016 to affected customers via email and certified mail if no email address was available. The letter identified the affected product, problem and actions to be taken. For questions Customer Service at 877-741-5369 or support@merge.com. |
| Quantity | 844 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 |