Recall Z-3004-2026 ยท LLZ System, Image Processing, Radiological
Merge Healthcare, Inc.
Merge PACS and Merge OrthoPACS, medical imaging diagnostic workstation
| Date | Aug 21, 2026 (initiated Jul 22, 2026) |
| Status | Open, Classified |
| Reason | Software issue may cause measurements to be displayed inaccurately. |
| Root cause | Software Design Change |
| Action | Merge Healthcare issued an Urgent Field Safety Notice to its consignees on 7/22/2026 via email with a follow-up telephone call. The notice explained the issue and how to identify it, risk to patient, and requested the following: "Immediate actions to reduce risk to patients Merge Healthcare recommends that customers contact Merge Healthcare Support to identify any affected ultrasound studies and the necessary next steps to be taken. Until the software update is installed, ultrasound measurements performed using the Merge PACS & OrthoPACS Viewer should be confirmed against the measurements a |
| Quantity | 20 units |
| Distribution | US Nationwide distribution in the states of California, Florida, Kentucky, Nebraska, Washington. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K192455 | Merge PACS Merge Healthcare Incorporated, Oct 17, 2019 |