Recall Z-2874-2026— Merge Healthcare, Inc.

Class II · Ongoing

Class II FDA medical device recall by Merge Healthcare, Inc., initiated 2026-06-30. It names one FDA 510(k) clearance: K192455. Product: Merge PACS, medical imaging diagnostic workstation. Reason: Thumbnails from a previously opened patient study may be displayed in the Thumbnail Bar while a different patient study is currently open..

Recalling firm
Merge Healthcare, Inc.
Classification
Class II
Status
Ongoing
Initiated
2026-06-30
Firm location
Hartland, WI, United States

510(k) clearances named in this recall

1 on FDA's record

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, medical imaging diagnostic workstation

Reason for recall

Thumbnails from a previously opened patient study may be displayed in the Thumbnail Bar while a different patient study is currently open.

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