Recall Z-2341-2016— Merge Healthcare, Inc.

Name: FDA recall Z-2341-2016
Creator: U.S. Food and Drug Administration
Published: 2012-07-02

Class II · Terminated

Class II FDA medical device recall by Merge Healthcare, Inc., initiated 2012-07-02, terminated 2017-06-26. It names one FDA 510(k) clearance: K082421. Product: Merge HEMO software.. Reason: The International Normalized Ratio (INR) value displayed in the study report does not match the value that is imported on the pre-procedure labs screen from HL7.

Recalling firm: Merge Healthcare, Inc.
Classification: Class II
Status: Terminated
Initiated: 2012-07-02
Terminated: 2017-06-26
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.

Reason for recall

The International Normalized Ratio (INR) value displayed in the study report does not match the value that is imported on the pre-procedure labs screen from HL7

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