Recall Z-1431-2017 ยท LLZ System, Image Processing, Radiological
Merge Healthcare, Inc.
Merge PACS software. The firm name on the label is Merge Healthcare.
| Date | Apr 4, 2016 |
| Status | Terminated |
| Reason | Studies that have QC, PDE, or HL7 ADT updates applied may fail to propagate via telmed protocol to the destination server and may fail to import on the destination server. |
| Root cause | Software design |
| Action | Merge sent an Urgent: Medical Device Recall letter dated March 28, 2016, to all affected customers via email the week of April 4, 2016. If no email address was available, the letters were issued via certified mail. A letter dated February 21, 2017 , was issued was also issued via email or certified mail. The letter notifies the customer of the issue, informs them not receiving updated demographics or image content may result in delay in diagnosis or treatment of the patient or misdiagnosis, and they should be aware of the workaround. The customer is also notified a fix is not yet available |
| Quantity | 248 sites potentially have the affected versions |
| Distribution | USA (nationwide ) Distribution was made to medical facilities. Internationally to Canada. There was no government or military distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K082144 | AMICAS PACS, VERSION 6.0 Amicas, Inc., Sep 5, 2008 |