Recall Z-2303-2016— Merge Healthcare, Inc.

Name: FDA recall Z-2303-2016
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 2021-05-07. It names one FDA 510(k) clearance: K082144. Product: Merge PACS software. The firm name on the label is Merge Healthcare, Hartland, Wisconsin. Merge PACS 6.0 is software intended to create and display two-dimensional and three-dimensional images of anatomy from a series of digitally acquired images.. Reason: A migrated study that has annotations will display the annotations, but when a prior study is loaded that should have annotations, the second study will not display annotations..

Recalling firm: Merge Healthcare, Inc.
Classification: Class II
Status: Terminated
Initiated: 2016-01-30
Terminated: 2021-05-07
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. The firm name on the label is Merge Healthcare, Hartland, Wisconsin. Merge PACS 6.0 is software intended to create and display two-dimensional and three-dimensional images of anatomy from a series of digitally acquired images.

Reason for recall

A migrated study that has annotations will display the annotations, but when a prior study is loaded that should have annotations, the second study will not display annotations.

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