Recall Z-1496-2017 ยท LLZ System, Image Processing, Radiological
Merge Healthcare, Inc.
Merge Cardio software with Issuer of Patient ID (IPID). The firm name on the label is Merge Healthcare, Hartland, WI.
| Date | Mar 20, 2017 (initiated Sep 22, 2015) |
| Status | Terminated |
| Reason | For sites using the Issuer of Patient ID (IPID), the system will display the study list and images from different patients with different IPIDs as though they are for the same patient if they all have the first name, last name, and medical record number in common. |
| Root cause | Process design |
| Action | Merge sent an Urgent: Medical Device Recall letter dated March 28, 2016, via email the week of April 4, 2016, or via certified mail if they did not have an email address for the customer. On/about September 22, 2015, the recalling firm emailed "IMPORTANT PRODUCT INFORMATION" letters dated August 20, 2015, to their customers. The letter notifies the customer of the issue and informs them a fix for the issue is in the new software release. The notification instructs the customer to pass the information onto all other users, as well as any downstream customers if it was further distributed. |
| Quantity | 16 sites were originally identified as potentially having the affected versions |
| Distribution | US Distribution was made to medical facilities located in GA, IL, MD, MI, MO, OH, TN, and VT. There was no foreign/government/military 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 |