Recall Z-2865-2016 ยท LLZ System, Image Processing, Radiological
Merge Healthcare, Inc.
Merge Cardio software. Product Usage: Merge Cardio is an integrated cardiovascular information system classified as a picture archiving and communications system.
| Date | Jan 30, 2016 |
| Status | Terminated |
| Reason | Patient information in the header is only found on the first page of the report and not on the subsequent pages. |
| Root cause | Software design |
| Action | Merge sent an Urgent Medical Device Recall letter dated January 28, 2016 to affected customers via e-mail or via certified mail if they did not have an e-mail address. The letter identified the affected product, problem and actions to be taken. For questions call Merge Customer Service at (877)741-5369 or support@merge.com. |
| Quantity | 42 sites potentially have the affected version |
| Distribution | US Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K051649 | VERICIS CARDIOVASCULAR IMAGE AND INFORMATION SYSTEM, MODEL 4.0 Camtronics Medical Systems, Aug 2, 2005 |