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Terminated

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

FDA Recall Z-1457-2017 · Posted None

Recalling FirmMerge Healthcare, Inc.
Recall StatusTerminated
Product CodeDQK
Date Initiated2016-04-04
Date Terminated2019-08-05
Product Quantity361 sites potentially have the affected versions

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.

Firm Action

The recalling firm issued a letter dated March 28, 2016 via e-mail. If no email address was available, the letters were issued via certified mail. Non-responders were issued letters on July 11, 2016. The letter identified the affected product, problem and actions to be taken. For question send an email to [email protected].

Root Cause

Software design

Distribution Pattern

US Nationwide Distribution.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K082421HEARTSUITE HEMODYNAMICS 7.10Emageon, Inc. · 2008-12-17

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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