Recall Z-2709-2016 ยท LLZ System, Image Processing, Radiological
Merge Healthcare, Inc.
Merge Cardio software. The firm name on the label is Merge Healthcare, Hartland, WI. Image processing system.
| Date | Sep 1, 2016 (initiated Feb 9, 2016) |
| Status | Terminated |
| Reason | A report can be confirmed with the incorrect patient demographics resulting in it being saved under the incorrect patient record in the Electronic Medical Record (EMR). |
| Root cause | Software design |
| Action | MERGE sent an Urgent Medical Device Recall letter dated February 9, 2016, to all affected customers via email or via certified mail if they did not have an e-mail address for the customer. The notification instructs the customer to pass the information onto all other users, as well as any downstream customers if it was further distributed. In addition, the customer is requested to call Customer Service or send them an email to schedule the upgrade. If the customer chooses not to upgrade, they are requested to complete the attached form or go online and complete it. For further questions, p |
| Quantity | 116 customers potentially have the affected versions |
| Distribution | 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 |