Recall Z-2363-2016— Merge Healthcare, Inc.

Name: FDA recall Z-2363-2016
Creator: U.S. Food and Drug Administration
Published: 2016-02-05

Class II · Terminated

Class II FDA medical device recall by Merge Healthcare, Inc., initiated 2016-02-05, terminated 2016-10-25. It names one FDA 510(k) clearance: K082144. Product: Merge PACS software. The firm name on the label is Merge Healthcare, Inc., Hartland, WI. Intended to create and display two-dimensional and three-dimensional images of anatomy from a series of digitally acquired images.. Reason: When measuring a lesion on an unmagnified mammography image then performing the same measurement on an image magnified by the Hologic imager (different image), the measurements are not the same..

Recalling firm: Merge Healthcare, Inc.
Classification: Class II
Status: Terminated
Initiated: 2016-02-05
Terminated: 2016-10-25
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, Inc., Hartland, WI. Intended to create and display two-dimensional and three-dimensional images of anatomy from a series of digitally acquired images.

Reason for recall

When measuring a lesion on an unmagnified mammography image then performing the same measurement on an image magnified by the Hologic imager (different image), the measurements are not the same.

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