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Terminated

Merge HEMO software.

FDA Recall Z-2341-2016 · Posted 2016-08-04

Recalling FirmMerge Healthcare, Inc.
Recall StatusTerminated
Product CodeDQK
Date Initiated2012-07-02
Date Terminated2017-06-26
Product Quantity37

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

Firm Action

The firm issued an "Important Product Information" bulletin to customers dated 7/2/2012 via e-mail letting them know there was an upgrade available. On 1/30/2016, the recalling firm initiated phone calls to their customers letting them know there was an upgrade available and if they declined it, they would like a written response.

Root Cause

Software design

Distribution Pattern

The medical facilities who currently have the affected versions are located nationwide. There was government distribution but no military or foreign 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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