Recall Z-2379-2016— Merge Healthcare, Inc.

Name: FDA recall Z-2379-2016
Creator: U.S. Food and Drug Administration
Published: 2016-01-30

Class II · Terminated

Class II FDA medical device recall by Merge Healthcare, Inc., initiated 2016-01-30, terminated 2020-10-05. It names one FDA 510(k) clearance: K082144. Product: Merge PACS software. Product was distributed under the AMICAS label, Brighton, MA, but labeling was later changed to Merge Healthcare, Hartland, WI.. Reason: The patient name in the Halo title bar and the thumbnails do not match the name on displayed images..

Recalling firm: Merge Healthcare, Inc.
Classification: Class II
Status: Terminated
Initiated: 2016-01-30
Terminated: 2020-10-05
Firm location: Hartland, WI, United States

510(k) clearances named in this recall

1 on FDA's record

K082144 — AMICAS PACS, VERSION 6.0Amicas, Inc.·cleared 2008-09-05

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 software. Product was distributed under the AMICAS label, Brighton, MA, but labeling was later changed to Merge Healthcare, Hartland, WI.

Reason for recall

The patient name in the Halo title bar and the thumbnails do not match the name on displayed images.

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