Recall Z-1457-2017— Merge Healthcare, Inc.

Name: FDA recall Z-1457-2017
Creator: U.S. Food and Drug Administration
Published: 2016-04-04

Class II · Terminated

Class II FDA medical device recall by Merge Healthcare, Inc., initiated 2016-04-04, terminated 2019-08-05. It names one FDA 510(k) clearance: K082421. Product: Merge Hemo software. Product Usage: Merge Hemo is a hemodynamic monitoring system that records and displays physiological data.. Reason: In some instances, the system will lock tabs within a study, even when a second user does not have the study open on a different workstation..

Recalling firm: Merge Healthcare, Inc.
Classification: Class II
Status: Terminated
Initiated: 2016-04-04
Terminated: 2019-08-05
Firm location: Hartland, WI, United States

510(k) clearances named in this recall

1 on FDA's record

K082421 — HEARTSUITE HEMODYNAMICS 7.10Emageon, Inc.·cleared 2008-12-17

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 Hemo software. Product Usage: Merge Hemo is a hemodynamic monitoring system that records and displays physiological data.

Reason for recall

In some instances, the system will lock tabs within a study, even when a second user does not have the study open on a different workstation.

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