Recall Z-3004-2026— Merge Healthcare, Inc.

Name: FDA recall Z-3004-2026
Creator: U.S. Food and Drug Administration
Published: 2026-07-22

Class II · Ongoing

Class II FDA medical device recall by Merge Healthcare, Inc., initiated 2026-07-22. It names one FDA 510(k) clearance: K192455. Product: Merge PACS and Merge OrthoPACS, medical imaging diagnostic workstation. Reason: Software issue may cause measurements to be displayed inaccurately..

Recalling firm: Merge Healthcare, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2026-07-22
Firm location: Hartland, WI, United States

510(k) clearances named in this recall

1 on FDA's record

K192455 — Merge PACSMerge Healthcare Incorporated·cleared 2019-10-17

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Merge PACS and Merge OrthoPACS, medical imaging diagnostic workstation

Reason for recall

Software issue may cause measurements to be displayed inaccurately.

Data sourced from openFDA. This site is unofficial and independent of the FDA.